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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00280540
• Lead Sponsor: Novartis

Brief Summary

This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-19
• Study First Posted: 2006-01-23
• Primary Completion: 2006-08
• Status Verified: 2008-03
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 648

Inclusion Criteria

• Male or female age 18 or older
• Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg)

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Exclusion Criteria

• Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
• History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
• History of myocardial infarction, stroke [e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline systolic blood pressure after 4 weeks
Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period
Blood pressure less than 140/90 mmHg after 6 weeks
Change from baseline diastolic blood pressure after 6 weeks
Change from baseline in blood and urine markers after 6 weeks

Trial Locations

Locations (1)

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