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

Condition(s) targeted: Hypertension

Intervention: Valsartan/hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis EH P, Study Chair, Affiliation: Sponsor

The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.

Official 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in MSSBP from baseline to Week 8

Secondary outcome:

Change in mean sitting diastolic blood pressure (MSDBP) from baseline to Weeks 4, 8, 12 and 16

Proportion of patients achieving blood pressure (BP) control at Weeks 4, 8, 12 and 16

Change from baseline in postprandial glucose, insulin and non-esterified fatty acids 2 hours after an oral glucose tolerance test at Week 16

Evaluate safety and tolerability baseline to Week 16

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Terence T. Hart, MD, Muscle Shoals, Alabama 35662, United States

Westlake Medical Research, Westlake Village, California 91361, United States

Oklahoma Cardiovascular & Hypertension, Oklahoma City, Oklahoma 73132, United States

Northeast Tarrant Internal Medicine Assoc, Euless, Texas 76040, United States

Frandsen Family Medicine, Port Orchard, Washington 98366, United States

Starting date: December 2006
Last updated: August 16, 2007