Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00425373
First received: January 22, 2007
Last updated: April 20, 2011
Last verified: April 2011
Results First Received: January 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: Valsartan + amlodipine 40/2.5 mg
Drug: Valsartan + amlodipine 40/5 mg
Drug: Valsartan + amlodipine 80/2.5 mg
Drug: Valsartan + amlodipine 80/5 mg
Drug: Valsartan 40 mg
Drug: Valsartan 80 mg
Drug: Amlodipine 2.5 mg
Drug: Amlodipine 5 mg
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 40/2.5 mg Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + Amlodipine 40/5 mg Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + Amlodipine 80/2.5 mg Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + Amlodipine 80/5 mg Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mg Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mg Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mg Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mg Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Placebo 4 tablet and 2 capsule placebos taken once daily

Participant Flow:   Overall Study
    Valsartan + Amlodipine 40/2.5 mg   Valsartan + Amlodipine 40/5 mg   Valsartan + Amlodipine 80/2.5 mg   Valsartan + Amlodipine 80/5 mg   Valsartan 40 mg   Valsartan 80 mg   Amlodipine 2.5 mg   Amlodipine 5 mg   Placebo
STARTED   159   167   160   162   169   163   161   161   166 
COMPLETED   154   164   157   160   159   154   154   151   148 
NOT COMPLETED   5   3   3   2   10   9   7   10   18 
Adverse Event                2                2                0                1                4                6                2                3                8 
Lost to Follow-up                0                1                0                0                1                0                0                0                0 
Protocol Violation                1                0                1                0                0                0                0                5                3 
Withdrawal by Subject                2                0                2                1                4                0                2                2                2 
Lack of Efficacy                0                0                0                0                1                3                3                0                5 



  Baseline Characteristics
  Hide Baseline Characteristics

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 40/2.5 mg Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + Amlodipine 40/5 mg Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + Amlodipine 80/2.5 mg Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + Amlodipine 80/5 mg Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mg Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mg Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mg Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mg Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Placebo 4 tablet and 2 capsule placebos taken once daily
Total Total of all reporting groups

Baseline Measures
   Valsartan + Amlodipine 40/2.5 mg   Valsartan + Amlodipine 40/5 mg   Valsartan + Amlodipine 80/2.5 mg   Valsartan + Amlodipine 80/5 mg   Valsartan 40 mg   Valsartan 80 mg   Amlodipine 2.5 mg   Amlodipine 5 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   167   160   162   169   163   161   161   166   1468 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.9  (10.34)   52.8  (10.70)   52.8  (10.76)   54.1  (9.75)   52.9  (10.08)   52.6  (11.29)   53.2  (10.83)   54.4  (10.67)   51.5  (10.58)   53.1  (10.57) 
Gender 
[Units: Participants]
                   
Female   46   49   40   39   38   49   49   40   55   405 
Male   113   118   120   123   131   114   112   121   111   1063 


  Outcome Measures
  Show All Outcome Measures

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 MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]

4.  Secondary:   Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)   [ Time Frame: Baseline to end of study (Week 8) ]

5.  Secondary:   Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg 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
  Hide 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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00425373     History of Changes
Other Study ID Numbers: CVAA489A1301
Study First Received: January 22, 2007
Results First Received: January 12, 2011
Last Updated: April 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare