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

April 19, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35662
        • Terence T. Hart, MD
    • California
      • Westlake Village, California, United States, 91361
        • Westlake Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73132
        • Oklahoma Cardiovascular & Hypertension
    • Texas
      • Euless, Texas, United States, 76040
        • Northeast Tarrant Internal Medicine Assoc
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Frandsen Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Time Frame: Baseline to Week 8
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time Frame: Baseline to Weeks 4, 8, 12 and 16
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
Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)
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
Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)
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
Week 16
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
Week 16
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
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 23, 2007

First Posted (Estimate)

February 26, 2007

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAH631BUS06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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