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Trial record 12 of 101 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001572
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : May 24, 2011
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: Valsartan/amlodipine 160/5 mg
Drug: Valsartan 160 mg
Drug: Placebo
Enrollment 932
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Single-Blind Run -In Valsartan 160 mg Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Hide Arm/Group Description Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks. 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. One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Period Title: Single-Blind Valsartan 160 mg
Started 932 0 [1] 0 [1]
Completed 654 0 0
Not Completed 278 0 0
Reason Not Completed
Withdrawal by Subject             32             0             0
Adverse Event             11             0             0
Abnormal Test Procedure Result(s)             96             0             0
Unsatisfactory therapeutic effect             7             0             0
Abnormal Laboratory Value             1             0             0
Lost to Follow-up             4             0             0
Administrative problems             82             0             0
Condition no longer requires study drug             45             0             0
[1]
Participants did not enroll into this arm during single blind period.
Period Title: Double-Blind Treatment Phase
Started 0 [1] 329 325
Full Analysis Set (FAS) 0 328 [2] 323 [3]
Completed 0 319 306
Not Completed 0 10 19
Reason Not Completed
Adverse Event             0             2             2
Withdrawal by Subject             0             8             13
Abnormal test procedure result(s)             0             0             1
Unsatisfactory therapeutic effect             0             0             1
Protocol deviation             0             0             1
Lost to Follow-up             0             0             1
[1]
This arm is only used for single blind period. So, no enrollment during double blind period.
[2]
One patient was excluded from full analysis set for having no post-baseline efficacy assessment.
[3]
Two patients were excluded from full analysis set for having no post-baseline efficacy assessment.
Arm/Group Title Valsartan/Amlodipine 160/5 mg Valsartan 160 mg Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 328 323 651
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 328 participants 323 participants 651 participants
52.9  (9.47) 53.1  (9.41) 53.0  (9.43)
[1]
Measure Description: Baseline Measures were based on the Full Analysis Set that excludes 3 participants for having no post-baseline efficacy assessment.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants 323 participants 651 participants
Female
141
  43.0%
150
  46.4%
291
  44.7%
Male
187
  57.0%
173
  53.6%
360
  55.3%
1.Primary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.
Arm/Group Title Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Hide Arm/Group Description:
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.
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Overall Number of Participants Analyzed 328 323
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-10.3  (0.39) -6.6  (0.40)
2.Secondary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint
Hide Description 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
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.
Arm/Group Title Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Hide Arm/Group Description:
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.
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Overall Number of Participants Analyzed 328 323
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-14.9  (0.61) -7.0  (0.61)
3.Secondary Outcome
Title Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.
Arm/Group Title Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Hide Arm/Group Description:
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.
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Overall Number of Participants Analyzed 328 323
Measure Type: Number
Unit of Measure: Percentage of Participants
70.1 52.6
4.Secondary Outcome
Title Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.
Arm/Group Title Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Hide Arm/Group Description:
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.
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Overall Number of Participants Analyzed 328 323
Measure Type: Number
Unit of Measure: Percentage of Participants
65.9 50.8
5.Secondary Outcome
Title Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.
Arm/Group Title Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Hide Arm/Group Description:
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.
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Overall Number of Participants Analyzed 328 323
Measure Type: Number
Unit of Measure: Percentage of Participants
61.3 39.3
Time Frame Week 8
Adverse Event Reporting Description Safety population included all randomized patients who received at least one dose of double-blind trial medication.
 
Arm/Group Title Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Hide Arm/Group Description 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. One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
All-Cause Mortality
Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/329 (0.00%)   1/325 (0.31%) 
Reproductive system and breast disorders     
Uterine polyp  1  0/329 (0.00%)  1/325 (0.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valsartan/Amlodipine 160/5 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/329 (0.00%)   0/325 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01001572    
Other Study ID Numbers: CVAA489A2317
First Submitted: October 15, 2009
First Posted: October 26, 2009
Results First Submitted: April 22, 2011
Results First Posted: May 24, 2011
Last Update Posted: May 24, 2011