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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan/Hydrochlorothiazide; Drug: HCTZ

• Registration Number: NCT00277472
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2005-11
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-16
• Status Verified: 2008-03
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
valsartan HCTZ	Valsartan/Hydrochlorothiazide	-
HCTZ	HCTZ	-

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States