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Study Results
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Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
This study has been completed.
Study NCT00413413   Information provided by Novartis

First Received on December 18, 2006.   Last Updated on April 26, 2011   History of Changes
Results First Received: August 6, 2009  
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: Valsartan 80 mg
Drug: Valsartan 160 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
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Valsartan/Amlodipine 80/5 mg 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
Valsartan 80 mg 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Valsartan 160 mg 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Participant Flow for 2 periods

Period 1:   Single-Blind
    Valsartan/Amlodipine 80/5 mg     Valsartan 80 mg     Valsartan 160 mg  
STARTED     0 [1]   1134     0 [1]
COMPLETED     0     918     0  
NOT COMPLETED     0     216     0  
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 2:   Double-Blind
    Valsartan/Amlodipine 80/5 mg     Valsartan 80 mg     Valsartan 160 mg  
STARTED     308     307     303  
COMPLETED     293     293     285  
NOT COMPLETED     15     14     18  
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  



  Baseline Characteristics
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Reporting Groups
  Description
Valsartan/Amlodipine 80/5 mg 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
Valsartan 80 mg 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Valsartan 160 mg 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Baseline Measures
    Valsartan/Amlodipine 80/5 mg     Valsartan 80 mg     Valsartan 160 mg     Total  
Number of Participants  
[units: participants]
  308     306     302     916  
Age [1]
[units: years]
Mean ± Standard Deviation
  51.6  ± 10.8     51.7  ± 8.9     51.2  ± 9.6     51.5  ± 9.8  
Gender  
[units: participants]
       
Female     127     115     104     346  
Male     181     191     198     570  
[1] 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.



  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 Blood Pressure 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 Blood Pressure Control at the End of the Study (Week 8)   [ Time Frame: End of study (Week 8) ]

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


  Serious Adverse Events
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  Other Adverse Events
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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.


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


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00413413     History of Changes
Other Study ID Numbers: CVAA489A2316
Study First Received: December 18, 2006
Results First Received: August 6, 2009
Last Updated: April 26, 2011
Health Authority: China: State Food and Drug Administration;   United States: Food and Drug Administration