Trial Outcomes & Findings for Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension (NCT NCT01001572)
NCT ID: NCT01001572
Last Updated: 2011-05-24
Results Overview
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.
COMPLETED
PHASE3
932 participants
Baseline and Week 8
2011-05-24
Participant Flow
932 participants were entered into the single-blind valsartan 160 mg arm. 278 participants were discontinued from the single-blind arm. 654 participants were randomized into the double-blind treatment phase; 329 to the Valsartan/amlodipine arm and 325 to the valsartan alone arm.
Participant milestones
| Measure |
Single-Blind Run -In Valsartan 160 mg
Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
|
Valsartan/Amlodipine 160/5 mg
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|---|
|
Single-Blind Valsartan 160 mg
STARTED
|
932
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
COMPLETED
|
654
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
NOT COMPLETED
|
278
|
0
|
0
|
|
Double-Blind Treatment Phase
STARTED
|
0
|
329
|
325
|
|
Double-Blind Treatment Phase
Full Analysis Set (FAS)
|
0
|
328
|
323
|
|
Double-Blind Treatment Phase
COMPLETED
|
0
|
319
|
306
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
0
|
10
|
19
|
Reasons for withdrawal
| Measure |
Single-Blind Run -In Valsartan 160 mg
Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
|
Valsartan/Amlodipine 160/5 mg
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|---|
|
Single-Blind Valsartan 160 mg
Withdrawal by Subject
|
32
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
Adverse Event
|
11
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
Abnormal Test Procedure Result(s)
|
96
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
Unsatisfactory therapeutic effect
|
7
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
Abnormal Laboratory Value
|
1
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
Lost to Follow-up
|
4
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
Administrative problems
|
82
|
0
|
0
|
|
Single-Blind Valsartan 160 mg
Condition no longer requires study drug
|
45
|
0
|
0
|
|
Double-Blind Treatment Phase
Adverse Event
|
0
|
2
|
2
|
|
Double-Blind Treatment Phase
Withdrawal by Subject
|
0
|
8
|
13
|
|
Double-Blind Treatment Phase
Abnormal test procedure result(s)
|
0
|
0
|
1
|
|
Double-Blind Treatment Phase
Unsatisfactory therapeutic effect
|
0
|
0
|
1
|
|
Double-Blind Treatment Phase
Protocol deviation
|
0
|
0
|
1
|
|
Double-Blind Treatment Phase
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Baseline characteristics by cohort
| Measure |
Valsartan/Amlodipine 160/5 mg
n=328 Participants
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
n=323 Participants
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
Total
n=651 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52.9 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 9.41 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
187 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
360 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.
Outcome measures
| Measure |
Valsartan/Amlodipine 160/5 mg
n=328 Participants
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
n=323 Participants
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
|
-10.3 mmHg
Standard Error 0.39
|
-6.6 mmHg
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate
Outcome measures
| Measure |
Valsartan/Amlodipine 160/5 mg
n=328 Participants
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
n=323 Participants
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint
|
-14.9 mmHg
Standard Error 0.61
|
-7.0 mmHg
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.
The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) \< 90 mmHg or a \>= 10 mmHg reduction from baseline.
Outcome measures
| Measure |
Valsartan/Amlodipine 160/5 mg
n=328 Participants
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
n=323 Participants
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|
|
Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint
|
70.1 Percentage of Participants
|
52.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.
The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) \< 90 mmHg.
Outcome measures
| Measure |
Valsartan/Amlodipine 160/5 mg
n=328 Participants
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
n=323 Participants
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|
|
Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint
|
65.9 Percentage of Participants
|
50.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.
The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) \< 140/90 mmHg.
Outcome measures
| Measure |
Valsartan/Amlodipine 160/5 mg
n=328 Participants
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
n=323 Participants
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|
|
Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint
|
61.3 Percentage of Participants
|
39.3 Percentage of Participants
|
Adverse Events
Valsartan/Amlodipine 160/5 mg
Valsartan 160 mg
Serious adverse events
| Measure |
Valsartan/Amlodipine 160/5 mg
n=329 participants at risk
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
|
Valsartan 160 mg
n=325 participants at risk
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/329 • Week 8
Safety population included all randomized patients who received at least one dose of double-blind trial medication.
|
0.31%
1/325 • Week 8
Safety population included all randomized patients who received at least one dose of double-blind trial medication.
|
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