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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: HCTZ + Amlodipine
* Drug: Valsartan/HCTZ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: valsartan/HCTZ<br> | Drug: Valsartan/HCTZ<br>* 160 mg film-coated valsartan tablets 320 mg film-coated valsartan tablets 12.5 mg HCTZ capsules 25 mg HCTZ capsules<br>|
| Active Comparator: HCTZ +Amlodipine<br> | Drug: HCTZ + Amlodipine<br>* 12.5 mg HCTZ capsules 25 mg HCTZ capsules 5 mg amlodipine capsules 10 mg amlodipine capsules<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) |  | 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 | 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 | 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 | Week 16 | 
| Change From Baseline in Postprandial Insulin | 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 | After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, hypertension, valsartan/hydrochlorothiazide