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

Novartis

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00933920

CTRI/2009/091/000287

CSPP100A2110

26-06-2009

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

Fed Group

Active Comparator group

Treatment:

Drug: Aliskiren

Drug: Aliskiren

Fasted group

Active Comparator group

Treatment:

Drug: Aliskiren

Drug: Aliskiren