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

Condition(s) targeted: Hypertension

Intervention: Valsartan/Hydrochlorothiazide (Drug); HCTZ (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis 862-778-8300 Pharmaceuticals, Study Director, Affiliation: Novartis

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

Official title: A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks

Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks

Secondary outcome:

Change from baseline in systolic blood pressure after 2 weeks and 4 weeks

Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks

Change in systolic blood pressure at 20 weeks compared to 4 weeks

Change in diastolic blood pressure at 20 weeks compared to 4 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Novartis, East Hanover, New Jersey 07936, United States

Starting date: November 2005
Last updated: June 6, 2011