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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00933920

Collaborator

(none)

124

Enrollment

Locations

Arms

24.8

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Aliskiren Drug: Aliskiren	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fed Group	Drug: Aliskiren
Active Comparator: Fasted group	Drug: Aliskiren

Arm

Intervention/Treatment

Active Comparator: Fed Group

Drug: Aliskiren

Active Comparator: Fasted group

Drug: Aliskiren

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigator Site	Coimbatore	India
2	Novartis Investigative Site	Hyderabaad	India
3	Novartis Investigator Site	Hyderabaad	India
4	Novartis Investigator Site	Mangalore	India
5	Novartis Investigative Site	New Delhi	India