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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

726 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aliskiren/HCTZ

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No