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

Novartis Pharmaceuticals412 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

412

Conditions

Hypertension

Interventions

HCTZ + AmlodipineDRUG

* 12.5 mg HCTZ capsules * 25 mg HCTZ capsules * 5 mg amlodipine capsules * 10 mg amlodipine capsules

Valsartan/HCTZDRUG

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (5)

Terence T. Hart, MD

Muscle Shoals, Alabama, United States

Westlake Medical Research

Westlake Village, California, United States

Oklahoma Cardiovascular & Hypertension

Oklahoma City, Oklahoma, United States

Northeast Tarrant Internal Medicine Assoc

Euless, Texas, United States

Outcomes

Primary Outcomes

Change in Mean Sitting Systolic Blood Pressure (MSSBP)

Time frame: Baseline to Week 8

Secondary Outcomes

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)

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 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)

Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 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)

Change From Baseline in Postprandial Glucose

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Time frame: Week 16

Change From Baseline in Postprandial Insulin

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Time frame: Week 16

Change From Baseline in Postprandial Non-esterified Fatty Acids

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Time frame: Week 16

Data from ClinicalTrials.gov

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