A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

901 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-02-29

Brief Summary

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Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.

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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

Participants Investigators

Study Groups

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Aliskiren-based regimen

Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning

Amlodipine

Intervention Type DRUG

Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning

Ramipril-based regimen

Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg

Group Type ACTIVE_COMPARATOR

Ramipril

Intervention Type DRUG

Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning

Amlodipine

Intervention Type DRUG

Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning

Interventions

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Aliskiren

Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning

Intervention Type DRUG

Ramipril

Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning

Intervention Type DRUG

Amlodipine

Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients ≥ 65 years old.
* Patients with essential hypertension with an msSBP ≥ 140 mmHg and \< 180 mmHg, and msDBP \< 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
* Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
* Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).

Exclusion Criteria

* History of renal artery stenosis.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy.
* Current diagnosis of heart failure (New York Heart Association Class III-IV).
* History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
* History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
* Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
* Clinically significant valvular heart disease.
* Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No