Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00387517
• Lead Sponsor: Novartis

Brief Summary

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

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: 2006-10
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 726

Inclusion Criteria

• Male or female outpatients 18 years old or older.

• Patients with a diagnosis of hypertension defined as follows:

  • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit 1.
  • All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit 2.
  • All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit 5.

• Patients who are eligible and consent to participate in the study

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Exclusion Criteria

• Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
• Previous or current diagnosis of heart failure.
• History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
• 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
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.

Secondary Outcome Measures

Name	Time	Method
Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
Safety and tolerability
Proportion of patients achieving a blood pressure control target at week 8

Trial Locations

Locations (1)

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