Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine

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

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.

Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.

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Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non responder Olmesartan/Amlodipine

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Group Type EXPERIMENTAL

Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Intervention Type DRUG

Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Interventions

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Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ

Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Essential hypertension stage II
* Male and female patients
* Age \>= 18 years old

Exclusion Criteria

* Severe hypertension (systolic BP \>= 180 mmHg, diastolic BP \>= 110 mmHg
* Poorly controlled diabetes mellitus or type 1 DM
* History of myocardial infarction, stroke
* Presence of heart failure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No