Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

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Detailed Description

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Conditions

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Moderate to Severe Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aliskiren/amlodipine 300/10 mg tablet

Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.

Group Type EXPERIMENTAL

Aliskiren/amlodipine 300/10 mg tablet

Intervention Type DRUG

Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Amlodipine 10 mg capsule

Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.

Group Type ACTIVE_COMPARATOR

Amlodipine 10 mg capsule

Intervention Type DRUG

Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Interventions

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Aliskiren/amlodipine 300/10 mg tablet

Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Intervention Type DRUG

Amlodipine 10 mg capsule

Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients ≥ 18 years of age
* Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and \< 200 mmHg at Visit 2

Exclusion Criteria

* Mild to moderate hypertension
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
* History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
* Patients on a combination of 3 or more antihypertensive medications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No