Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension

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

PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate 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

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Fed Group

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

Fasted group

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

Interventions

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Aliskiren

Intervention Type DRUG

Aliskiren

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* Secondary form of hypertension.
* Type 1 or type 2 diabetes mellitus
* Serum potassium out side laboratory reference range
* Any history of hypertensive encephalopathy or cerebrovascular accident

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No