Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 99 for:    AMLODIPINE AND VALSARTAN

Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With 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: NCT00413413
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : September 14, 2009
Last Update Posted : April 28, 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: Valsartan 80 mg
Drug: Valsartan 160 mg
Enrollment 1134
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Period Title: Single-Blind
Started 0 [1] 1134 0 [1]
Completed 0 918 0
Not Completed 0 216 0
Reason Not Completed
Adverse Event             0             9             0
Lack of Efficacy             0             5             0
Subject no longer requires study drug             0             151             0
Protocol Violation             0             16             0
Withdrawal by Subject             0             27             0
Lost to Follow-up             0             8             0
[1]
In single-blind period participants were only enrolled to Valsartan 80 mg arm.
Period Title: Double-Blind
Started 308 307 303
Completed 293 293 285
Not Completed 15 14 18
Reason Not Completed
Adverse Event             6             0             5
Unsatisfactory therapeutic effect             1             2             1
Protocol deviation             1             2             1
Subject withdrew consent             4             6             9
Lost to Follow-up             3             4             2
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg Total
Hide Arm/Group Description 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily Total of all reporting groups
Overall Number of Baseline Participants 308 306 302 916
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 308 participants 306 participants 302 participants 916 participants
51.6  (10.8) 51.7  (8.9) 51.2  (9.6) 51.5  (9.8)
[1]
Measure Description: All baseline measures were based on Full-set analysis population. Two patients were excluded from the full-set analysis population for having no post-baseline efficacy assessment. All randomized patients were included in the safety population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 306 participants 302 participants 916 participants
Female
127
  41.2%
115
  37.6%
104
  34.4%
346
  37.8%
Male
181
  58.8%
191
  62.4%
198
  65.6%
570
  62.2%
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.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Overall Number of Participants Analyzed 308 306 302
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-10.8  (0.42) -6.3  (0.42) -7.2  (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.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Overall Number of Participants Analyzed 308 306 302
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-12.5  (0.61) -6.0  (0.62) -7.7  (0.62)
3.Secondary Outcome
Title Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)
Hide Description 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.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Overall Number of Participants Analyzed 308 306 302
Measure Type: Number
Unit of Measure: Percentage of patients
77.9 57.8 66.6
4.Secondary Outcome
Title Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)
Hide Description 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.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Overall Number of Participants Analyzed 308 306 302
Measure Type: Number
Unit of Measure: Percentage of patients
74.4 53.6 64.2
5.Secondary Outcome
Title Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
Hide Description 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.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Overall Number of Participants Analyzed 308 306 302
Measure Type: Number
Unit of Measure: Percentage of patients
70.5 44.1 58.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
All-Cause Mortality
Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valsartan/Amlodipine 80/5 mg Valsartan 80 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/308 (1.30%)   0/307 (0.00%)   4/303 (1.32%) 
Blood and lymphatic system disorders       
Leukopenia  1  0/308 (0.00%)  0/307 (0.00%)  1/303 (0.33%) 
Eye disorders       
Retinal haemorrhage  1  1/308 (0.32%)  0/307 (0.00%)  0/303 (0.00%) 
Injury, poisoning and procedural complications       
Abdominal injury  1  1/308 (0.32%)  0/307 (0.00%)  0/303 (0.00%) 
Investigations       
Liver function test abnormal  1  1/308 (0.32%)  0/307 (0.00%)  0/303 (0.00%) 
Nervous system disorders       
Cerebral infarction  1  0/308 (0.00%)  0/307 (0.00%)  3/303 (0.99%) 
Transient ischaemic attack  1  1/308 (0.32%)  0/307 (0.00%)  0/303 (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 Valsartan 80 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/308 (0.00%)   0/307 (0.00%)   0/303 (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: NCT00413413     History of Changes
Other Study ID Numbers: CVAA489A2316
First Submitted: December 18, 2006
First Posted: December 19, 2006
Results First Submitted: August 6, 2009
Results First Posted: September 14, 2009
Last Update Posted: April 28, 2011