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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00413049
First received: December 18, 2006
Last updated: April 26, 2011
Last verified: April 2011
Results First Received: January 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Valsartan/amlodipine 80/5 mg
Drug: Amlodipine 5 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Valsartan/Amlodipine 80/5 mg 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.
Amlodipine 5 mg 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.

Participant Flow:   Overall Study
    Valsartan/Amlodipine 80/5 mg     Amlodipine 5 mg  
STARTED     349     349  
COMPLETED     325     331  
NOT COMPLETED     24     18  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Valsartan/Amlodipine 80/5 mg 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.
Amlodipine 5 mg 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 Total of all reporting groups

Baseline Measures
    Valsartan/Amlodipine 80/5 mg     Amlodipine 5 mg     Total  
Number of Participants  
[units: participants]
  347     349     696  
Age  
[units: years]
Mean ± Standard Deviation
  53.4  ± 9.7     54.2  ± 9.1     53.8  ± 9.4  
Gender  
[units: participants]
     
Female     134     109     243  
Male     213     240     453  



  Outcome Measures
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1.  Primary:   Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]

2.  Secondary:   Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]

3.  Secondary:   Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]

4.  Secondary:   Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]

5.  Secondary:   Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]

6.  Secondary:   Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided


Responsible Party: Novartis Medical Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00413049     History of Changes
Other Study ID Numbers: CVAA489A2315
Study First Received: December 18, 2006
Results First Received: January 11, 2011
Last Updated: April 26, 2011
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration