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Trial record 6 of 101 for:    AMLODIPINE AND VALSARTAN

Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00413049
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : February 8, 2011
Last Update Posted : April 29, 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 Hypertension
Interventions Drug: Valsartan/amlodipine 80/5 mg
Drug: Amlodipine 5 mg
Enrollment 698
Recruitment Details  
Pre-assignment Details Two patients in the valsartan/amlodipine group were excluded from the intent-to-treat population used for the efficacy analyses for having no post-baseline efficacy assessment.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description 1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. 1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Period Title: Overall Study
Started 349 349
Completed 325 331
Not Completed 24 18
Reason Not Completed
Adverse Event             10             8
Withdrawal by Subject             7             5
Lost to Follow-up             2             3
Protocol Violation             3             1
Subject no longer requires study drug             0             1
Abnormal laboratory value(s)             1             0
Lack of Efficacy             1             0
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg Total
Hide Arm/Group Description 1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. 1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. Total of all reporting groups
Overall Number of Baseline Participants 347 349 696
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 347 participants 349 participants 696 participants
53.4  (9.7) 54.2  (9.1) 53.8  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
Female
134
  38.6%
109
  31.2%
243
  34.9%
Male
213
  61.4%
240
  68.8%
453
  65.1%
1.Primary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Hide Description 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. A negative change score indicates lowered BP.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Overall Number of Participants Analyzed 347 349
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-9.7  (0.42) -7.1  (0.42)
2.Secondary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
Hide Description 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. A negative change score indicates lowered BP.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Overall Number of Participants Analyzed 347 349
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-11.4  (0.61) -7.4  (0.60)
3.Secondary Outcome
Title Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)
Hide Description A patient achieved a diastolic response if their msDBP < 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP 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.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Overall Number of Participants Analyzed 347 349
Measure Type: Number
Unit of Measure: Percentage of patients
79.3 66.8
4.Secondary Outcome
Title Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)
Hide Description A patient achieved diastolic control if their 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.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Overall Number of Participants Analyzed 347 349
Measure Type: Number
Unit of Measure: Percentage of patients
75.5 64.5
5.Secondary Outcome
Title Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)
Hide Description A patient achieved overall control if the 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.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Overall Number of Participants Analyzed 347 349
Measure Type: Number
Unit of Measure: Percentage of patients
69.2 57.6
6.Secondary Outcome
Title Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)
Hide Description Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic BP -6.3  (5.85) 0.3  (5.82)
Systolic BP -7.3  (7.62) -0.2  (8.64)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Hide Arm/Group Description 1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. 1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
All-Cause Mortality
Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/349 (1.15%)   2/349 (0.57%) 
Gastrointestinal disorders     
Gastric ulcer  1  1/349 (0.29%)  1/349 (0.29%) 
Injury, poisoning and procedural complications     
Humerus fracture  1  1/349 (0.29%)  0/349 (0.00%) 
Musculoskeletal and connective tissue disorders     
Jaw cyst  1  1/349 (0.29%)  0/349 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Parathyroid tumour benign  1  0/349 (0.00%)  1/349 (0.29%) 
Nervous system disorders     
Post herpetic neuralgia  1  1/349 (0.29%)  0/349 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valsartan/Amlodipine 80/5 mg Amlodipine 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/349 (0.00%)   0/349 (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: Novartis Medical Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00413049     History of Changes
Other Study ID Numbers: CVAA489A2315
First Submitted: December 18, 2006
First Posted: December 19, 2006
Results First Submitted: January 11, 2011
Results First Posted: February 8, 2011
Last Update Posted: April 29, 2011