Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-04-30

Brief Summary

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This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet taken once daily in the morning with a light meal.

Aliskiren 75 mg

Group Type EXPERIMENTAL

Aliskiren 75 mg

Intervention Type DRUG

Aliskiren 75 mg tablet taken once daily in the morning with a light meal.

Aliskiren 150 mg

Group Type EXPERIMENTAL

Aliskiren 150 mg

Intervention Type DRUG

Aliskiren 150 mg tablet taken once daily in the morning with a light meal.

Aliskiren 300 mg

Group Type EXPERIMENTAL

Aliskiren 300 mg

Intervention Type DRUG

Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Interventions

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Placebo

Placebo tablet taken once daily in the morning with a light meal.

Intervention Type DRUG

Aliskiren 75 mg

Aliskiren 75 mg tablet taken once daily in the morning with a light meal.

Intervention Type DRUG

Aliskiren 150 mg

Aliskiren 150 mg tablet taken once daily in the morning with a light meal.

Intervention Type DRUG

Aliskiren 300 mg

Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients 65 years of age and older.
* Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
* At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and \< 180 mmHg (msDBP \<110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion Criteria

* Severe hypertension \[Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg\].
* History or evidence of a secondary form of hypertension.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
* Current diagnosis of heart failure (NYHA Class II-IV).
* History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
* Current angina pectoris requiring pharmacological therapy other than nitrates.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No