Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-08-31

Brief Summary

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This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 mmHg).

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Detailed Description

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Conditions

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Essential Hypertension ( Mild to Moderate)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aliskiren-based regimen

All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren 150 or 300 mg

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 12.5 or 25 mg

Amlodipine

Intervention Type DRUG

Amlodipine 5 or 10 mg

Interventions

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Aliskiren

Aliskiren 150 or 300 mg

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide 12.5 or 25 mg

Intervention Type DRUG

Amlodipine

Amlodipine 5 or 10 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients ≥ 18 years of age
* Patients with a diagnosis of mild to moderate hypertension at Visit 1
* All patients must have a msSBP ≥ 140 mmHg and \< 180 mmHg and/or msDBP ≥ 90 mmHg and \< 110 mmHg mmHg at Visit 3

Exclusion Criteria

* Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg
* Secondary form of hypertension
* Current diagnosis of heart failure (NYHA Class II-IV)
* Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates)
* Second or third degree heart block without a pacemaker
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No