Trial Outcomes & Findings for Study of Efficacy and Safety of CVAA489 in Hypertensive Patients (NCT NCT02062645)
NCT ID: NCT02062645
Last Updated: 2017-03-28
Results Overview
Control rate of BP defined as BP lower than 140/90 mmHg at office visits
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
115 participants
Primary outcome timeframe
At week 4 and 8
Results posted on
2017-03-28
Participant Flow
One hundred thirty patients were screened and 115 were enrolled into the trial.
Participant milestones
| Measure |
Amlodipine/Valsartan
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Amlodipine/Valsartan
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
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|---|---|
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Overall Study
Adverse Event
|
2
|
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Overall Study
Protocol Violation
|
8
|
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Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Study of Efficacy and Safety of CVAA489 in Hypertensive Patients
Baseline characteristics by cohort
| Measure |
Amlodipine/Valsartan
n=100 Participants
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
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|---|---|
|
Age, Continuous
|
55.06 years
STANDARD_DEVIATION 11.22 • n=99 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
|
Systolic blood pressure
|
164.3 mmHG
STANDARD_DEVIATION 13.2 • n=99 Participants
|
|
Diastolic blood pressure
|
96.7 mmHg
STANDARD_DEVIATION 12.7 • n=99 Participants
|
|
Heart rate
|
80.15 beats/min
STANDARD_DEVIATION 10.00 • n=99 Participants
|
|
Body mass index
|
31.19 kg/m^2
STANDARD_DEVIATION 5.32 • n=99 Participants
|
PRIMARY outcome
Timeframe: At week 4 and 8Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Control rate of BP defined as BP lower than 140/90 mmHg at office visits
Outcome measures
| Measure |
Amlodipine/Valsartan
n=100 Participants
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
|
|---|---|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 4 Systolic (n=100)
|
47.0 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 4 Diastolic (n=100)
|
78.0 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 4 Overall Blood Pressure(n=100)
|
45.0 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 Systolic(n=91)
|
70.3 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 Diastolic (n=91)
|
82.4 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 Overall Blood Pressure (n=91)
|
67.0 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 Systolic (LOCF) (n=100)
|
68.0 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 Diastolic (LOCF) (n=100)
|
81.0 Percentage of Participants
|
|
Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 Overall Blood Pressure (LOCF) (n=100)
|
65.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: baseline, week 4, week 8Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Change in systolic blood pressure measured in office from baseline at week 4 and 8.
Outcome measures
| Measure |
Amlodipine/Valsartan
n=100 Participants
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
|
|---|---|
|
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Systolic blood pressure (SBP) Day 0 (n=100)
|
164.3 mmHg
Standard Deviation 13.2
|
|
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Systolic blood pressure (SBP) Week 4 (n=100)
|
140.17 mmHg
Standard Deviation 14.05
|
|
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Systolic blood pressure (SBP) Week 8 (n=91)
|
134.04 mmHg
Standard Deviation 13.51
|
|
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Systolic blood pressure (SBP) Week 8 LOCF (n=100)
|
134.71 mmHg
Standard Deviation 13.37
|
|
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Decrease in Systolic Week 4 (n=100)
|
24.15 mmHg
Standard Deviation 18.18
|
|
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Decrease in Systolic Week 8 (n=91)
|
30.22 mmHg
Standard Deviation 18.25
|
|
Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Decrease in Systolic BP Week 8 LOCF (n=100)
|
29.61 mmHg
Standard Deviation 17.81
|
SECONDARY outcome
Timeframe: baseline, week 4, week 8Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.
Outcome measures
| Measure |
Amlodipine/Valsartan
n=100 Participants
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
|
|---|---|
|
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Diastolic blood pressure (DBP) Day 0 (n=100)
|
96.66 mmHg
Standard Deviation 12.68
|
|
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Diastolic blood pressure (DBP) Week 4 (n=100)
|
82.0 mmHg
Standard Deviation 9.88
|
|
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Diastolic blood pressure (DBP) Week 8 (n=91)
|
81.04 mmHg
Standard Deviation 8.66
|
|
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Diastolic blood pressure (DBP) Week 8 LOCF (n=100)
|
81.37 mmHg
Standard Deviation 8.69
|
|
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Decrease in Diastolic BP Week 4 (n=100)
|
14.66 mmHg
Standard Deviation 12.58
|
|
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Decrease in Diastolic BP Week 8 (n=91)
|
15.54 mmHg
Standard Deviation 13.19
|
|
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Decrease in Diastolic BP Week 8 LOCF (n=100)
|
15.29 mmHg
Standard Deviation 12.73
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SECONDARY outcome
Timeframe: At week 4 and 8Population: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values
Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (\>100 mEq/day)
Outcome measures
| Measure |
Amlodipine/Valsartan
n=70 Participants
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
|
|---|---|
|
Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 4 (n=70)
|
68.6 Percentage of participants
|
|
Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 (n=64)
|
64.1 Percentage of participants
|
|
Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Week 8 LOCF (n=70)
|
62.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At week 4 and 8Population: All patients received amlodipine/valsartan 160/5 mg daily at Day 0 and were up titrated to amlodipine/valsartan 160/10 mg daily at visit 2 (week 4) if their hypertension can not be controlled. The duration of treatment period was 8 weeks.
Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.
Outcome measures
| Measure |
Amlodipine/Valsartan
n=70 Participants
All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
|
|---|---|
|
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
SBP at Week 4 (n=70)
|
140.01 mmHg
Standard Deviation 13.67
|
|
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
SBP at Week 8 (n=64)
|
134.20 mmHg
Standard Deviation 13.24
|
|
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
SBP at Week 8 LOCF (n=70)
|
134.84 mmHg
Standard Deviation 13.17
|
|
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
DBP at Week 4 (n=70)
|
81.73 mmHg
Standard Deviation 10.26
|
|
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
DBP at Week 8 (n=64)
|
81.23 mmHg
Standard Deviation 8.80
|
|
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
DBP at Week 8 LOCF (n=70)
|
81.47 mmHg
Standard Deviation 8.91
|
Adverse Events
Amlodipine/Valsartan
Serious events: 3 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amlodipine/Valsartan
n=110 participants at risk
amlodipine/valsartan
|
|---|---|
|
General disorders
Death
|
0.91%
1/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.91%
1/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.91%
1/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
Other adverse events
| Measure |
Amlodipine/Valsartan
n=110 participants at risk
amlodipine/valsartan
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
7/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Cardiac disorders
Aortic valve incompetence
|
9.1%
10/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Cardiac disorders
Diastolic dysfunction
|
4.5%
5/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Cardiac disorders
Left atrial dilatation
|
3.6%
4/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Cardiac disorders
Left ventricular dysfunction
|
30.9%
34/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
27.3%
30/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Cardiac disorders
Mitral valve incompetence
|
14.5%
16/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
7.3%
8/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
3/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
General disorders
Oedema peripheral
|
2.7%
3/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Investigations
Blood uric acid increased
|
2.7%
3/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Investigations
Electrocardiogram abnormal
|
2.7%
3/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Investigations
Urine sodium increased
|
7.3%
8/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Renal and urinary disorders
Microalbuminuria
|
5.5%
6/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.7%
3/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
|
Vascular disorders
Aortic aneurysm
|
3.6%
4/110
The safety population included data from patients who attended Visit 2 which was 110 patients.
|
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 (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER