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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan/HCTZ; Drug: HCTZ + Amlodipine

• Registration Number: NCT00439738
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-26
• Primary Completion: 2007-11
• Results First Submitted: 2008-11-05
• Results First Submitted QC: 2009-02-09
• Results First Posted: 2009-02-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
valsartan/HCTZ	Valsartan/HCTZ	-
HCTZ +Amlodipine	HCTZ + Amlodipine	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Sitting Systolic Blood Pressure (MSSBP)	Baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
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)	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
Change From Baseline in Postprandial Insulin	Week 16	After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)	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
Change From Baseline in Postprandial Glucose	Week 16	After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Change From Baseline in Postprandial Non-esterified Fatty Acids	Week 16	After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

Trial Locations

Locations (5)

Terence T. Hart, MD; 🇺🇸 Muscle Shoals, Alabama, United States

Oklahoma Cardiovascular & Hypertension; 🇺🇸 Oklahoma City, Oklahoma, United States

Northeast Tarrant Internal Medicine Assoc; 🇺🇸 Euless, Texas, United States

Frandsen Family Medicine; 🇺🇸 Port Orchard, Washington, United States

Westlake Medical Research; 🇺🇸 Westlake Village, California, United States