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

A Randomized, Single-blind, Parallel Group, Multiple Oral Dose Study to Evaluate the Effect of a Light Meal on the Pharmacokinetics and Pharmacodynamics of Aliskiren Using Market 300 mg Tablet Formulation in Subjects With Mild to Moderate Hypertension

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00933920

Enrollment

124

Registered

2009-07-07

Start date

2009-06-30

Completion date

Unknown

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Aliskiren,, hypertension,, renin-angiotensin-aldosterone system,, pharmacokinetics,, pharmacodynamics

Brief summary

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.

Interventions

DRUGAliskiren

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
Compare PK (AUC & Cmax) and PD, i.e. PRA (Plasma Renin Activity, AUE) of aliskiren when given with and without light meal.	28 Days

Secondary

Measure	Time frame
Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal	28 Days
Assess safety and tolerability of aliskiren when given with and without light meal	28 days
Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal	28 days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026