Trial Outcomes & Findings for Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension (NCT NCT01237223)
NCT ID: NCT01237223
Last Updated: 2012-06-13
Results Overview
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1342 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2012-06-13
Participant Flow
Participant milestones
| Measure |
Placebo
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
|
Aliskiren 150 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
|---|---|---|---|---|---|---|
|
Single Blind(Run-in Period, 4 Weeks)
STARTED
|
1342
|
0
|
0
|
0
|
0
|
0
|
|
Single Blind(Run-in Period, 4 Weeks)
COMPLETED
|
944
|
0
|
0
|
0
|
0
|
0
|
|
Single Blind(Run-in Period, 4 Weeks)
NOT COMPLETED
|
398
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (Treatment Period, 8 Weeks)
STARTED
|
153
|
157
|
158
|
158
|
159
|
159
|
|
Double Blind (Treatment Period, 8 Weeks)
COMPLETED
|
120
|
142
|
143
|
153
|
155
|
154
|
|
Double Blind (Treatment Period, 8 Weeks)
NOT COMPLETED
|
33
|
15
|
15
|
5
|
4
|
5
|
Reasons for withdrawal
| Measure |
Placebo
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
|
Aliskiren 150 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
|---|---|---|---|---|---|---|
|
Single Blind(Run-in Period, 4 Weeks)
Adverse Event
|
29
|
0
|
0
|
0
|
0
|
0
|
|
Single Blind(Run-in Period, 4 Weeks)
Abnormal laboratory value(s)
|
25
|
0
|
0
|
0
|
0
|
0
|
|
Single Blind(Run-in Period, 4 Weeks)
Abnormal test procedure result(s)
|
308
|
0
|
0
|
0
|
0
|
0
|
|
Single Blind(Run-in Period, 4 Weeks)
Subject withdrew consent
|
28
|
0
|
0
|
0
|
0
|
0
|
|
Single Blind(Run-in Period, 4 Weeks)
Protocol deviation(s)
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Double Blind (Treatment Period, 8 Weeks)
Adverse Event
|
12
|
4
|
3
|
2
|
2
|
1
|
|
Double Blind (Treatment Period, 8 Weeks)
Unsatisfactory therapeutic effect
|
20
|
6
|
7
|
1
|
0
|
1
|
|
Double Blind (Treatment Period, 8 Weeks)
Withdrawal by Subject
|
1
|
4
|
4
|
0
|
1
|
1
|
|
Double Blind (Treatment Period, 8 Weeks)
Administrative problems
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Double Blind (Treatment Period, 8 Weeks)
Protocol deviation(s)
|
0
|
1
|
1
|
2
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=153 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
|
Aliskiren 150 mg
n=157 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Total
n=944 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
54.6 years
STANDARD_DEVIATION 8.35 • n=39 Participants
|
55.0 years
STANDARD_DEVIATION 9.96 • n=41 Participants
|
54.8 years
STANDARD_DEVIATION 10.25 • n=35 Participants
|
55.8 years
STANDARD_DEVIATION 10.05 • n=31 Participants
|
54.6 years
STANDARD_DEVIATION 11.11 • n=146 Participants
|
55.5 years
STANDARD_DEVIATION 9.86 • n=19 Participants
|
55.1 years
STANDARD_DEVIATION 9.96 • n=147 Participants
|
|
Age, Customized
< 65 years
|
128 participants
n=39 Participants
|
131 participants
n=41 Participants
|
129 participants
n=35 Participants
|
126 participants
n=31 Participants
|
125 participants
n=146 Participants
|
127 participants
n=19 Participants
|
766 participants
n=147 Participants
|
|
Age, Customized
>=65 years
|
25 participants
n=39 Participants
|
26 participants
n=41 Participants
|
29 participants
n=35 Participants
|
32 participants
n=31 Participants
|
34 participants
n=146 Participants
|
32 participants
n=19 Participants
|
178 participants
n=147 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
51 Participants
n=31 Participants
|
51 Participants
n=146 Participants
|
57 Participants
n=19 Participants
|
288 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=39 Participants
|
118 Participants
n=41 Participants
|
113 Participants
n=35 Participants
|
107 Participants
n=31 Participants
|
108 Participants
n=146 Participants
|
102 Participants
n=19 Participants
|
656 Participants
n=147 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Outcome measures
| Measure |
Placebo
n=153 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
|
Aliskiren 150 mg
n=157 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)
|
-5.21 mm Hg
Standard Error 0.69
|
-7.49 mm Hg
Standard Error 0.68
|
-9.46 mm Hg
Standard Error 0.68
|
-11.90 mm Hg
Standard Error 0.68
|
-12.40 mm Hg
Standard Error 0.68
|
-16.43 mm Hg
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Outcome measures
| Measure |
Placebo
n=153 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
|
Aliskiren 150 mg
n=157 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)
|
-4.57 mm Hg
Standard Error 0.97
|
-10.63 mm Hg
Standard Error 0.96
|
-13.16 mm Hg
Standard Error 0.96
|
-17.98 mm Hg
Standard Error 0.96
|
-18.15 mm Hg
Standard Error 0.96
|
-25.49 mm Hg
Standard Error 0.96
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication
Blood pressure control is defined as having as a msDBP \< 90 mmHg and a msSBP \< 140 mmHg.
Outcome measures
| Measure |
Placebo
n=153 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
|
Aliskiren 150 mg
n=157 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Blood Pressure Control at Endpoint
|
16.3 percentage of participants
|
25.5 percentage of participants
|
32.9 percentage of participants
|
50.0 percentage of participants
|
45.9 percentage of participants
|
69.2 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication
The response rate was defined as percentage of participants who achieved msDBP \< 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.
Outcome measures
| Measure |
Placebo
n=153 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
|
Aliskiren 150 mg
n=157 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Successful Response Rate
|
34.6 percentage of participants
|
46.5 percentage of participants
|
50.6 percentage of participants
|
70.3 percentage of participants
|
65.4 percentage of participants
|
86.2 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Safety set: All patients who received at least one dose of double-blind study medication.
Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.
Outcome measures
| Measure |
Placebo
n=153 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
|
Aliskiren 150 mg
n=157 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 Participants
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Serious Adverse Events
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death
Adverse Events
|
62 Participants
|
57 Participants
|
50 Participants
|
49 Participants
|
57 Participants
|
59 Participants
|
Adverse Events
Placebo (Double Blind)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Aliskiren 150 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Amlodipine 2.5 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Amlodipine 5 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Aliskiren/Amlodipine 150/2.5 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Aliskiren/Amlodipine 150/5 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo (Single-Blind run-in Period)
Serious events: 4 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Double Blind)
n=153 participants at risk
In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
|
Aliskiren 150 mg
n=157 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Placebo (Single-Blind run-in Period)
n=1342 participants at risk
In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/153
|
0.00%
0/157
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
0.00%
0/159
|
0.00%
0/1342
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/153
|
0.00%
0/157
|
0.00%
0/158
|
0.63%
1/158
|
0.00%
0/159
|
0.00%
0/159
|
0.00%
0/1342
|
|
Infections and infestations
Pneumonia
|
0.00%
0/153
|
0.00%
0/157
|
0.63%
1/158
|
0.00%
0/158
|
0.00%
0/159
|
0.00%
0/159
|
0.00%
0/1342
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/153
|
0.00%
0/157
|
0.00%
0/158
|
0.00%
0/158
|
0.00%
0/159
|
0.63%
1/159
|
0.00%
0/1342
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/153
|
0.00%
0/157
|
0.00%
0/158
|
0.00%
0/158
|
0.00%
0/159
|
0.00%
0/159
|
0.07%
1/1342
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/153
|
0.00%
0/157
|
0.00%
0/158
|
0.00%
0/158
|
0.00%
0/159
|
0.00%
0/159
|
0.07%
1/1342
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/153
|
0.00%
0/157
|
0.00%
0/158
|
0.00%
0/158
|
0.00%
0/159
|
0.00%
0/159
|
0.07%
1/1342
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/153
|
0.00%
0/157
|
0.00%
0/158
|
0.00%
0/158
|
0.00%
0/159
|
0.00%
0/159
|
0.07%
1/1342
|
Other adverse events
| Measure |
Placebo (Double Blind)
n=153 participants at risk
In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
|
Aliskiren 150 mg
n=157 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 2.5 mg
n=158 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
|
Amlodipine 5 mg
n=158 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/2.5 mg
n=159 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
|
Aliskiren/Amlodipine 150/5 mg
n=159 participants at risk
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.
Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
|
Placebo (Single-Blind run-in Period)
n=1342 participants at risk
In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.2%
11/153
|
10.8%
17/157
|
8.9%
14/158
|
12.0%
19/158
|
10.1%
16/159
|
10.1%
16/159
|
6.0%
81/1342
|
|
Nervous system disorders
Headache
|
7.8%
12/153
|
3.2%
5/157
|
1.9%
3/158
|
1.3%
2/158
|
0.63%
1/159
|
1.9%
3/159
|
4.4%
59/1342
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER