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.”

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

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Valsartan/Hydrochlorothiazide

Primary Measures

• 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 Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis 862-778-8300 Pharmaceuticals Study Director Novartis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277472

Study ID Number: CVAH631BUS04

ClinicalTrials.gov Identifier: NCT00277472

Health Authority: United States: Food and Drug Administration

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