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

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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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: HCTZ + Amlodipine Drug: Valsartan/HCTZ Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Actual Primary Completion Date : November 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: valsartan/HCTZ Drug: Valsartan/HCTZ
  • 160 mg film-coated valsartan tablets
  • 320 mg film-coated valsartan tablets
  • 12.5 mg HCTZ capsules
  • 25 mg HCTZ capsules
Active Comparator: HCTZ +Amlodipine Drug: HCTZ + Amlodipine
  • 12.5 mg HCTZ capsules
  • 25 mg HCTZ capsules
  • 5 mg amlodipine capsules
  • 10 mg amlodipine capsules


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

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

  3. 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

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439738


Locations
United States, Alabama
Terence T. Hart, MD
Muscle Shoals, Alabama, United States, 35662
United States, California
Westlake Medical Research
Westlake Village, California, United States, 91361
United States, Oklahoma
Oklahoma Cardiovascular & Hypertension
Oklahoma City, Oklahoma, United States, 73132
United States, Texas
Northeast Tarrant Internal Medicine Assoc
Euless, Texas, United States, 76040
United States, Washington
Frandsen Family Medicine
Port Orchard, Washington, United States, 98366
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Results for CVAH631BUS06 from the Novartis Clinical Trials website  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00439738     History of Changes
Other Study ID Numbers: CVAH631BUS06
First Posted: February 26, 2007    Key Record Dates
Results First Posted: February 10, 2009
Last Update Posted: May 16, 2017
Last Verified: April 2017

Keywords provided by Novartis:
Obesity, hypertension, valsartan/hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors