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

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: NCT00439738
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : February 10, 2009
Last Update Posted : May 16, 2017
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE February 23, 2007
First Posted Date  ICMJE February 26, 2007
Results First Submitted Date  ICMJE November 5, 2008
Results First Posted Date  ICMJE February 10, 2009
Last Update Posted Date May 16, 2017
Study Start Date  ICMJE December 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
Change in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline to Week 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2007)
Change in MSSBP from baseline to Week 8
Change History Complete list of historical versions of study NCT00439738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Change in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline to Weeks 4, 8, 12 and 16 ]
  • 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) ]
    Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg
  • 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) ]
    Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg
  • Change From Baseline in Postprandial Glucose [ Time Frame: Week 16 ]
    After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
  • Change From Baseline in Postprandial Insulin [ Time Frame: Week 16 ]
    After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
  • Change From Baseline in Postprandial Non-esterified Fatty Acids [ Time Frame: Week 16 ]
    After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2007)
  • Change in mean sitting diastolic blood pressure (MSDBP) from baseline to Weeks 4, 8, 12 and 16
  • Proportion of patients achieving blood pressure (BP) control at Weeks 4, 8, 12 and 16
  • Change from baseline in postprandial glucose, insulin and non-esterified fatty acids 2 hours after an oral glucose tolerance test at Week 16
  • Evaluate safety and tolerability baseline to Week 16
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
Official Title  ICMJE A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients
Brief Summary The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: HCTZ + Amlodipine
    • 12.5 mg HCTZ capsules
    • 25 mg HCTZ capsules
    • 5 mg amlodipine capsules
    • 10 mg amlodipine capsules
  • Drug: Valsartan/HCTZ
    • 160 mg film-coated valsartan tablets
    • 320 mg film-coated valsartan tablets
    • 12.5 mg HCTZ capsules
    • 25 mg HCTZ capsules
Study Arms  ICMJE
  • Experimental: valsartan/HCTZ
    Intervention: Drug: Valsartan/HCTZ
  • Active Comparator: HCTZ +Amlodipine
    Intervention: Drug: HCTZ + Amlodipine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2008)
412
Original Enrollment  ICMJE
 (submitted: February 23, 2007)
392
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 40 years of age or older
  • Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
  • Central (abdominal) obesity

Exclusion Criteria:

  • Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
  • Currently taking more then 3 medications to treat high blood pressure
  • Inability to stop all current blood pressure medications if any up to 4 weeks
  • History of Type 1 or Type 2 diabetes
  • History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
  • History of or current diagnosis of congestive heart failure
  • History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma
  • Women who are pregnant or nursing
  • Alcohol or drug abuse within the last 2 years

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00439738
Other Study ID Numbers  ICMJE CVAH631BUS06
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP