Trial Outcomes & Findings for Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension (NCT NCT00413413)
NCT ID: NCT00413413
Last Updated: 2011-04-28
Results Overview
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
COMPLETED
PHASE3
1134 participants
Baseline to end of study (Week 8)
2011-04-28
Participant Flow
A total of 1134 patients were enrolled into the single-blind period of the study, and 216 (19%) were discontinued. In total, 918 patients were randomized to the three treatment groups.
Participant milestones
| Measure |
Valsartan/Amlodipine 80/5 mg
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Single-Blind
STARTED
|
0
|
1134
|
0
|
|
Single-Blind
COMPLETED
|
0
|
918
|
0
|
|
Single-Blind
NOT COMPLETED
|
0
|
216
|
0
|
|
Double-Blind
STARTED
|
308
|
307
|
303
|
|
Double-Blind
COMPLETED
|
293
|
293
|
285
|
|
Double-Blind
NOT COMPLETED
|
15
|
14
|
18
|
Reasons for withdrawal
| Measure |
Valsartan/Amlodipine 80/5 mg
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Single-Blind
Adverse Event
|
0
|
9
|
0
|
|
Single-Blind
Lack of Efficacy
|
0
|
5
|
0
|
|
Single-Blind
Subject no longer requires study drug
|
0
|
151
|
0
|
|
Single-Blind
Protocol Violation
|
0
|
16
|
0
|
|
Single-Blind
Withdrawal by Subject
|
0
|
27
|
0
|
|
Single-Blind
Lost to Follow-up
|
0
|
8
|
0
|
|
Double-Blind
Adverse Event
|
6
|
0
|
5
|
|
Double-Blind
Unsatisfactory therapeutic effect
|
1
|
2
|
1
|
|
Double-Blind
Protocol deviation
|
1
|
2
|
1
|
|
Double-Blind
Subject withdrew consent
|
4
|
6
|
9
|
|
Double-Blind
Lost to Follow-up
|
3
|
4
|
2
|
Baseline Characteristics
Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
Baseline characteristics by cohort
| Measure |
Valsartan/Amlodipine 80/5 mg
n=308 Participants
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
n=306 Participants
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
n=302 Participants
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Total
n=916 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
51.6 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
51.7 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
51.2 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
51.5 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
346 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
570 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Outcome measures
| Measure |
Valsartan/Amlodipine 80/5 mg
n=308 Participants
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
n=306 Participants
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
n=302 Participants
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
|
-10.8 mmHg
Standard Error 0.42
|
-6.3 mmHg
Standard Error 0.42
|
-7.2 mmHg
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full-set analysis population population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Outcome measures
| Measure |
Valsartan/Amlodipine 80/5 mg
n=308 Participants
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
n=306 Participants
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
n=302 Participants
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
|
-12.5 mmHg
Standard Error 0.61
|
-6.0 mmHg
Standard Error 0.62
|
-7.7 mmHg
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
A diastolic blood pressure response was defined as a msDBP \< 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Outcome measures
| Measure |
Valsartan/Amlodipine 80/5 mg
n=308 Participants
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
n=306 Participants
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
n=302 Participants
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)
|
77.9 Percentage of patients
|
57.8 Percentage of patients
|
66.6 Percentage of patients
|
SECONDARY outcome
Timeframe: End of study (Week 8)Population: Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Diastolic blood pressure control was defined as a msDBP \< 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Outcome measures
| Measure |
Valsartan/Amlodipine 80/5 mg
n=308 Participants
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
n=306 Participants
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
n=302 Participants
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)
|
74.4 Percentage of patients
|
53.6 Percentage of patients
|
64.2 Percentage of patients
|
SECONDARY outcome
Timeframe: End of study (Week 8)Population: Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Overall blood pressure control rate was defined as a msSBP/msDBP \< 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Outcome measures
| Measure |
Valsartan/Amlodipine 80/5 mg
n=308 Participants
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
n=306 Participants
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
n=302 Participants
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
|
70.5 Percentage of patients
|
44.1 Percentage of patients
|
58.6 Percentage of patients
|
Adverse Events
Valsartan/Amlodipine 80/5 mg
Valsartan 80 mg
Valsartan 160 mg
Serious adverse events
| Measure |
Valsartan/Amlodipine 80/5 mg
n=308 participants at risk
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
Valsartan 80 mg
n=307 participants at risk
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Valsartan 160 mg
n=303 participants at risk
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/308
|
0.00%
0/307
|
0.33%
1/303
|
|
Eye disorders
Retinal haemorrhage
|
0.32%
1/308
|
0.00%
0/307
|
0.00%
0/303
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.32%
1/308
|
0.00%
0/307
|
0.00%
0/303
|
|
Investigations
Liver function test abnormal
|
0.32%
1/308
|
0.00%
0/307
|
0.00%
0/303
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/308
|
0.00%
0/307
|
0.99%
3/303
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/308
|
0.00%
0/307
|
0.00%
0/303
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Novartis Pharmaceuticals
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.
- Publication restrictions are in place
Restriction type: OTHER