Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00439738
First received: February 23, 2007
Last updated: February 9, 2009
Last verified: January 2009
Results First Received: November 5, 2008  
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: HCTZ + Amlodipine
Drug: Valsartan/HCTZ

  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/HCTZ (Hydrochlorothiazide) No text entered.
HCTZ +Amlodipine No text entered.

Participant Flow:   Overall Study
    Valsartan/HCTZ (Hydrochlorothiazide)     HCTZ +Amlodipine  
STARTED     206     206  
COMPLETED     170     178  
NOT COMPLETED     36     28  
Withdrawal by Subject                 16                 13  
Adverse Event                 6                 4  
Lost to Follow-up                 5                 6  
Protocol Violation                 6                 3  
Lack of Efficacy                 2                 2  
Abnormal Lab Values                 1                 0  



  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/HCTZ (Hydrochlorothiazide) No text entered.
HCTZ +Amlodipine No text entered.
Total Total of all reporting groups

Baseline Measures
    Valsartan/HCTZ (Hydrochlorothiazide)     HCTZ +Amlodipine     Total  
Number of Participants  
[units: participants]
  206     206     412  
Age, Customized  
[units: participants]
     
< 65 years     172     180     352  
>=65 years     34     26     60  
Gender  
[units: participants]
     
Female     124     148     272  
Male     82     58     140  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mean Sitting Systolic Blood Pressure (MSSBP)   [ Time Frame: Baseline to Week 8 ]

2.  Secondary:   Change in Mean Sitting Diastolic Blood Pressure (MSDBP)   [ Time Frame: Baseline to Weeks 4, 8, 12 and 16 ]

3.  Secondary:   Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)   [ Time Frame: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16) ]

4.  Secondary:   Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)   [ Time Frame: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16) ]

5.  Secondary:   Change From Baseline in Postprandial Glucose   [ Time Frame: Week 16 ]

6.  Secondary:   Change From Baseline in Postprandial Insulin   [ Time Frame: Week 16 ]

7.  Secondary:   Change From Baseline in Postprandial Non-esterified Fatty Acids   [ Time Frame: Week 16 ]


  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
None


  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: 1-862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00439738     History of Changes
Other Study ID Numbers: CVAH631BUS06
Study First Received: February 23, 2007
Results First Received: November 5, 2008
Last Updated: February 9, 2009
Health Authority: United States: Food and Drug Administration