8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00327587
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

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: 2006-05
• Study First Submitted: 2006-05-16
• Study First Submitted QC: 2006-05-16
• Study First Posted: 2006-05-18
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2279

Inclusion Criteria

• Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg).

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Exclusion Criteria

• Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
• Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 1.
• Patients on four or more antihypertensive drugs at Visit 1.
• Arm circumference > 42 cm for patients participating in ABPM.

Other protocol-defined 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 diastolic blood pressure after 8 weeks
Change from baseline systolic blood pressure after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Blood pressure less than 140/90 mmHg after 8 weeks
Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks
Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements
Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals Corporation; 🇺🇸 E. Hanover, New Jersey, United States