Trial Outcomes & Findings for Effect of Chronic ACE and DPP4 Inhibition on Blood Pressure (NCT NCT02130687)
NCT ID: NCT02130687
Last Updated: 2022-03-02
Results Overview
The primary analyses will focus on mean arterial blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)
Results posted on
2022-03-02
Participant Flow
Participants were enrolled if they met inclusion and exclusion criteria. 174 were consented to enroll 106. In other words, 68 of 174 consented were excluded because they did not meet inclusion/exclusion criteria.
Participant milestones
| Measure |
Amlodipine
Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
|
Ramipril
Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
|
Valsartan
Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
|
|---|---|---|---|
|
Washout
STARTED
|
36
|
35
|
35
|
|
Washout
COMPLETED
|
36
|
33
|
31
|
|
Washout
NOT COMPLETED
|
0
|
2
|
4
|
|
Drug 1 Only
STARTED
|
36
|
33
|
31
|
|
Drug 1 Only
COMPLETED
|
33
|
30
|
30
|
|
Drug 1 Only
NOT COMPLETED
|
3
|
3
|
1
|
|
Crossover Period 1
STARTED
|
33
|
30
|
30
|
|
Crossover Period 1
COMPLETED
|
33
|
30
|
30
|
|
Crossover Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Drug 1 Only Between Periods 1 and 2
STARTED
|
33
|
30
|
30
|
|
Drug 1 Only Between Periods 1 and 2
COMPLETED
|
33
|
26
|
29
|
|
Drug 1 Only Between Periods 1 and 2
NOT COMPLETED
|
0
|
4
|
1
|
|
Crossover Period 2
STARTED
|
33
|
26
|
29
|
|
Crossover Period 2
COMPLETED
|
33
|
26
|
29
|
|
Crossover Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Drug 1 Only Between Periods 2 and 3
STARTED
|
33
|
26
|
29
|
|
Drug 1 Only Between Periods 2 and 3
COMPLETED
|
33
|
25
|
27
|
|
Drug 1 Only Between Periods 2 and 3
NOT COMPLETED
|
0
|
1
|
2
|
|
Crossover Period 3
STARTED
|
33
|
25
|
27
|
|
Crossover Period 3
COMPLETED
|
33
|
25
|
27
|
|
Crossover Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Chronic ACE and DPP4 Inhibition on Blood Pressure
Baseline characteristics by cohort
| Measure |
Amlodipine
n=36 Participants
Subjects in this arm will receive calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
|
Ramipril
n=35 Participants
Subjects will receive ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
|
Valsartan
n=35 Participants
Subjects will receive ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects will receive three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
Placebo: Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.
Sitagliptin: Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
Aprepitant: Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
Mixed Meal Test (MMT): The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
52.9 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
57.9 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
56.3 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
76 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=99 Participants
|
35 participants
n=107 Participants
|
35 participants
n=206 Participants
|
106 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)The primary analyses will focus on mean arterial blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=27 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=25 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=28 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=29 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=29 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Arterial Blood Pressure
|
94.42 mmHg
Standard Deviation 7.53
|
93.41 mmHg
Standard Deviation 8.75
|
91.54 mmHg
Standard Deviation 7.80
|
90.21 mmHg
Standard Deviation 12.46
|
89.88 mmHg
Standard Deviation 9.67
|
86.95 mmHg
Standard Deviation 10.16
|
94.54 mmHg
Standard Deviation 9.96
|
93.71 mmHg
Standard Deviation 10.75
|
93.98 mmHg
Standard Deviation 10.75
|
PRIMARY outcome
Timeframe: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=27 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=25 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=28 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=29 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=29 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Heart Rate
|
69.59 beats per minute
Standard Deviation 9.75
|
70.43 beats per minute
Standard Deviation 9.79
|
69.41 beats per minute
Standard Deviation 9.84
|
66.58 beats per minute
Standard Deviation 7.71
|
66.30 beats per minute
Standard Deviation 8.16
|
66.15 beats per minute
Standard Deviation 8.06
|
66.19 beats per minute
Standard Deviation 9.19
|
65.86 beats per minute
Standard Deviation 8.46
|
65.10 beats per minute
Standard Deviation 8.52
|
PRIMARY outcome
Timeframe: 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, or sitagliptin+aprepitant)The primary analyses will focus on blood pressure, heart rate, and norepinephrine (NE) concentrations during ramipril versus ramipril+sitagliptin, and during ramipril+sitagliptin versus ramipril+sitagliptin+aprepitant. We will make similar comparisons within the valsartan- and placebo-treated groups. In addition, we will compare blood pressure and heart rate parameters among the ramipril-treated, valsartan-treated, and placebo-treated groups during comparable concurrent treatment.
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=32 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=32 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=32 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=27 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=25 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=27 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Norepinephrine (NE) Concentrations
|
741.65 pg/mL
Standard Deviation 660.82
|
730.88 pg/mL
Standard Deviation 613.69
|
610.65 pg/mL
Standard Deviation 587.19
|
470.69 pg/mL
Standard Deviation 474.88
|
627.55 pg/mL
Standard Deviation 593.92
|
649.39 pg/mL
Standard Deviation 624.67
|
874.22 pg/mL
Standard Deviation 863.75
|
986.31 pg/mL
Standard Deviation 1114.67
|
1013.54 pg/mL
Standard Deviation 1073.91
|
SECONDARY outcome
Timeframe: for 5 minutes on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)Low frequency variability of systolic blood pressure will be measured using spectral analysis.
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=19 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=13 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=14 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=13 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Low Frequency Variability of Blood Pressure Activity
|
5.14 mmHg2
Standard Deviation 2.65
|
7.32 mmHg2
Standard Deviation 7.72
|
7.07 mmHg2
Standard Deviation 6.57
|
8.78 mmHg2
Standard Deviation 8.10
|
7.27 mmHg2
Standard Deviation 5.91
|
12.18 mmHg2
Standard Deviation 11.16
|
8.51 mmHg2
Standard Deviation 5.43
|
7.81 mmHg2
Standard Deviation 3.65
|
8.58 mmHg2
Standard Deviation 6.57
|
SECONDARY outcome
Timeframe: fasting at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)measure of effectiveness of DPP4 inhibitor
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=32 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=32 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=27 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=25 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=27 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=29 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=29 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Glucose
|
123.78 mg/dL
Standard Deviation 34.28
|
112.51 mg/dL
Standard Deviation 29.96
|
109.08 mg/dL
Standard Deviation 21.35
|
118.04 mg/dL
Standard Deviation 21.79
|
107.55 mg/dL
Standard Deviation 18.41
|
107.66 mg/dL
Standard Deviation 17.47
|
112.01 mg/dL
Standard Deviation 21.6
|
103.69 mg/dL
Standard Deviation 18.13
|
99.75 mg/dL
Standard Deviation 15.59
|
SECONDARY outcome
Timeframe: fasting insulin measured at 3 hours on the 7th day of each intervention (placebo, sitagliptin, sitatliptin+aprepitant)Measure of insulin resistance.
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=26 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=22 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=21 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=21 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=21 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=22 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=20 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=21 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=20 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Insulin
|
20.7 microU/mL
Standard Deviation 10.36
|
20.72 microU/mL
Standard Deviation 11.95
|
20.22 microU/mL
Standard Deviation 16.32
|
26.15 microU/mL
Standard Deviation 13.82
|
22.59 microU/mL
Standard Deviation 13.01
|
26.02 microU/mL
Standard Deviation 18.48
|
21.39 microU/mL
Standard Deviation 16.22
|
19.92 microU/mL
Standard Deviation 14.46
|
16.83 microU/mL
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)Measure of DPP4 inhibitor administration.
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=31 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=25 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=23 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=26 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=26 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=27 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=27 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dipeptidyl Peptidase IV (DPP4) Activity
|
20.27 nmol/mL/min
Standard Deviation 6.80
|
7.34 nmol/mL/min
Standard Deviation 2.98
|
6.96 nmol/mL/min
Standard Deviation 4.33
|
20.61 nmol/mL/min
Standard Deviation 6.24
|
8.78 nmol/mL/min
Standard Deviation 6.5
|
7.71 nmol/mL/min
Standard Deviation 3.4
|
19.4 nmol/mL/min
Standard Deviation 7.14
|
7.83 nmol/mL/min
Standard Deviation 4.07
|
6.70 nmol/mL/min
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: for 4.5 hours on the 7th day of each intervention (placebo, sitagliptin, sitagliptin+aprepitant)This is a measure of activity of the angiotensin-converting enzyme (ACE). The assay is a kinetic assay (Labcore) that measures the rate of cleavage of an added ACE substrate over time and the results are reported in Units, which represent the rate of increase in fluorescent metabolite over 30 minutes under standard conditions at 37C.
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=33 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=32 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=26 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=24 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=25 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=28 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Angiotensin Converting Enzyme (ACE) Activity
|
37.00 Units
Standard Deviation 14.56
|
40.15 Units
Standard Deviation 14.87
|
35.78 Units
Standard Deviation 13.73
|
15.44 Units
Standard Deviation 9.20
|
14.69 Units
Standard Deviation 9.37
|
13.46 Units
Standard Deviation 5.38
|
37.21 Units
Standard Deviation 14.75
|
36.68 Units
Standard Deviation 13.08
|
36.89 Units
Standard Deviation 13.20
|
SECONDARY outcome
Timeframe: Value provided is the AVERAGE of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.Average of measurements made every five minutes beginning just prior to (time 0) and for four hours after the ingestion of a mixed meal
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Arterial Blood Pressure
|
96.0 mmHg
Standard Deviation 10.0
|
93.6 mmHg
Standard Deviation 8.9
|
92.9 mmHg
Standard Deviation 8.7
|
94.2 mmHg
Standard Deviation 11.3
|
92.6 mmHg
Standard Deviation 10.7
|
91.0 mmHg
Standard Deviation 9.6
|
94.2 mmHg
Standard Deviation 11.6
|
96.1 mmHg
Standard Deviation 8.8
|
94.5 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Value provided is the average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal.The average of measurements made every five minutes prior to (time 0) and for four four hours after ingestion of a mixed meal
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Heart Rate
|
71.8 bpm
Standard Deviation 13.1
|
70.3 bpm
Standard Deviation 11.6
|
71.7 bpm
Standard Deviation 13.0
|
69.9 bpm
Standard Deviation 10.7
|
73.3 bpm
Standard Deviation 9.2
|
72.0 bpm
Standard Deviation 10.4
|
70.3 bpm
Standard Deviation 11.9
|
71.9 bpm
Standard Deviation 11.3
|
71.9 bpm
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Neuropeptide Y concentration prior to ingestion of the mixed meal.Measurement of Neuropeptide Y (NPY) concentrations
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=20 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=15 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=16 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neuropeptide Y
|
0.35 pM
Standard Error 0.28
|
0.52 pM
Standard Error 0.34
|
0.51 pM
Standard Error 0.33
|
0.32 pM
Standard Error 0.32
|
0.54 pM
Standard Error 0.26
|
0.52 pM
Standard Error 0.29
|
0.27 pM
Standard Error 0.15
|
0.50 pM
Standard Error 0.26
|
0.47 pM
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Urine was collected for sodium for 24 hrs prior to each of the study days listed below. Study days occurred after each 7-day treatment arm (placebo/placebo, sitagliptin/placebo, or sitagliptin/aprepitant) within 3 anti-hypertensive groups.Subjects will collect 24hr urine sample and bring with to the study day for analysis
Outcome measures
| Measure |
Amlodipine Plus Placebo/Placebo
n=29 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Sitagliptin/Placebo
n=29 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=29 Participants
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Ramipril Plus Placebo/Placebo
n=20 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for one week for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=20 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule.
|
Ramipril Plus Sitagliptin/Aprepitant
n=22 Participants
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Valsartan Plus Placebo/Placebo
n=26 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=26 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=25 Participants
Participants in this group received valsartan 320mg/d for 15 weeks. During this intervention period they also received sitagliptin 100mg/day and aprepitant 125mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
24hr Urinary Testing for Sodium
|
147.66 mEq
Standard Deviation 69.46
|
146.90 mEq
Standard Deviation 74.29
|
154.42 mEq
Standard Deviation 61.01
|
177.70 mEq
Standard Deviation 74.48
|
162.05 mEq
Standard Deviation 68.55
|
142.95 mEq
Standard Deviation 94.62
|
158.77 mEq
Standard Deviation 60.19
|
138.65 mEq
Standard Deviation 44.48
|
160.92 mEq
Standard Deviation 80.86
|
OTHER_PRE_SPECIFIED outcome
Timeframe: for 4.5 hours on the 7th day of each interventionrenin-angiotensin system measurements were not done because there were not significant differences in blood pressure
Outcome measures
Outcome data not reported
Adverse Events
Washout Prior to Amlodipine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Amlodipine Alone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Amlodipine Plus Sitagliptin/Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Amlodipine Plus Placebo/Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Amlodipine Plus Sitagliptin/Aprepitant
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Washout Prior to Ramipril
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ramipril Alone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ramipril Plus Placebo/Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ramipril Plus Sitagliptin/Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ramipril Plus Sitagliptin/Aprepitant
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Washout Prior to Valsartan
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Valsartan Alone
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Valsartan Plus Placebo/Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Valsartan Plus Sitagliptin/Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Valsartan Plus Sitagliptin/Aprepitant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Washout Prior to Amlodipine
n=36 participants at risk
Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. Subjects underwent washout prior to starting amlodipine.
|
Amlodipine Alone
n=36 participants at risk
Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received amlodipine alone.
|
Amlodipine Plus Sitagliptin/Placebo
n=33 participants at risk
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Placebo/Placebo
n=33 participants at risk
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=33 participants at risk
Participants received amlodipine 10mg/day for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Washout Prior to Ramipril
n=35 participants at risk
Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting ramipril.
|
Ramipril Alone
n=33 participants at risk
Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks.
After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received ramipril alone.
|
Ramipril Plus Placebo/Placebo
n=27 participants at risk
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=25 participants at risk
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
|
Ramipril Plus Sitagliptin/Aprepitant
n=28 participants at risk
Participants in this group received ramipril 10mg/d for 15 days. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Washout Prior to Valsartan
n=35 participants at risk
Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting valsartan.
|
Valsartan Alone
n=31 participants at risk
Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received valsartan alone.
|
Valsartan Plus Placebo/Placebo
n=28 participants at risk
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=29 participants at risk
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=29 participants at risk
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/27 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
|
Cardiac disorders
unstable angina
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/27 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
Other adverse events
| Measure |
Washout Prior to Amlodipine
n=36 participants at risk
Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. Subjects underwent washout prior to starting amlodipine.
|
Amlodipine Alone
n=36 participants at risk
Subjects in this arm received calcium channel blocker therapy with amlodipine 5mg daily for 3 days then 10mg daily for 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received amlodipine alone.
|
Amlodipine Plus Sitagliptin/Placebo
n=33 participants at risk
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Amlodipine Plus Placebo/Placebo
n=33 participants at risk
Participants received amlodipine 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
|
Amlodipine Plus Sitagliptin/Aprepitant
n=33 participants at risk
Participants received amlodipine 10mg/day for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Washout Prior to Ramipril
n=35 participants at risk
Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting ramipril.
|
Ramipril Alone
n=33 participants at risk
Subjects received ACE-inhibitor therapy with ramipril 5mg daily for 3 days, followed by 10mg daily for the remaining 15 weeks.
After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions were: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received ramipril alone.
|
Ramipril Plus Placebo/Placebo
n=27 participants at risk
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Ramipril Plus Sitagliptin/Placebo
n=25 participants at risk
Participants in this group received ramipril 10mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
|
Ramipril Plus Sitagliptin/Aprepitant
n=28 participants at risk
Participants in this group received ramipril 10mg/d for 15 days. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
|
Washout Prior to Valsartan
n=35 participants at risk
Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. Subjects underwent washout prior to starting valsartan.
|
Valsartan Alone
n=31 participants at risk
Subjects received ARB therapy with valsartan 160mg daily for 3 days, followed by 320mg daily for the remaining 15 weeks. After 4 weeks of treatment, subjects received three different 1 week concurrent interventions, in a cross-over fashion, separated by a 4 week washout. The interventions will be: placebo + placebo, sitagliptin + placebo, sitagliptin + aprepitant.
During the first four weeks and between crossover therapies, participants received valsartan alone.
|
Valsartan Plus Placebo/Placebo
n=28 participants at risk
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received two placebo capsules for 7 days.
|
Valsartan Plus Sitagliptin/Placebo
n=29 participants at risk
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and a placebo capsule for 7 days.
|
Valsartan Plus Sitagliptin/Aprepitant
n=29 participants at risk
Participants in this group received valsartan 320 mg/d for 15 weeks. During this intervention period they also received sitagliptin 100 mg/day and aprepitant 125 mg/d for one day followed by 80 mg/d for a total of 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
6.5%
2/31 • Number of events 2 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
|
Vascular disorders
edema
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
6.1%
2/33 • Number of events 3 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
|
Nervous system disorders
headache
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/27 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
7.1%
2/28 • Number of events 2 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
6.9%
2/29 • Number of events 2 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
|
Cardiac disorders
elevated blood pressure
|
11.1%
4/36 • Number of events 4 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
8.6%
3/35 • Number of events 3 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/27 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
|
Cardiac disorders
orthostasis
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
9.1%
3/33 • Number of events 3 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
9.1%
3/33 • Number of events 3 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/27 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.4%
1/29 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
|
Renal and urinary disorders
hypokalemia
|
0.00%
0/36 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/33 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/27 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/25 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/35 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/31 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/28 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
0.00%
0/29 • Adverse event data were collected through study completion or for approximately 15 weeks.
Information for adverse events are provided for each anti-hypertensive group. Most events occurred during periods before or between crossover treatment periods and these are listed as such.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place