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OpenTrials
Completed

NCT Number: NCT00439738

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

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.

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Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Terence T. Hart, MD, Muscle Shoals, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCTZ + Amlodipine

Drug
  • 12.5 mg HCTZ capsules
  • 25 mg HCTZ capsules
  • 5 mg amlodipine capsules
  • 10 mg amlodipine capsules

Valsartan/HCTZ

Drug
  • 160 mg film-coated valsartan tablets
  • 320 mg film-coated valsartan tablets
  • 12.5 mg HCTZ capsules
  • 25 mg HCTZ capsules

Primary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (MSSBP)

    Time frame: Baseline to Week 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
First posted
Feb 26, 2007
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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