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

Novartis

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: HCTZ + Amlodipine

Drug: Valsartan/HCTZ

Study type

Interventional

Funder types

Industry

Identifiers

NCT00439738

CVAH631BUS06

Details and patient eligibility

About

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.

Enrollment

412 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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