Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Valsartan/Hydrochlorothiazide; Drug: HCTZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT00277472

CVAH631BUS04

Details and patient eligibility

About

This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female 18 years of age and older
• Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg

Exclusion criteria

• • Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
• Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication
• History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

valsartan HCTZ

Experimental group

Treatment:

Drug: Valsartan/Hydrochlorothiazide

HCTZ

Active Comparator group

Treatment:

Drug: HCTZ