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

This study is currently recruiting participants.

Verified by Novartis, July 2009

First Received: July 3, 2009 Last Updated: July 6, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00933920

Purpose

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	Intervention	Phase
Hypertension	Drug: Aliskiren	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

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. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Assess safety and tolerability of aliskiren when given with and without light meal [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Evaluate the effect on mean sitting systolic and diastolic blood pressure of aliskiren when given with or without a light meal [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	June 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fed Group: Active Comparator	Drug: Aliskiren
Fasted group: Active Comparator	Drug: Aliskiren

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933920

Contacts

Contact: Novartis Pharmaceuticals

+41 61 324 1111

Locations

India
Novartis Investigative Site	Recruiting
New Delhi, India
Contact +41 61 324 1111
Novartis Investigative Site	Recruiting
Hyderabaad, India
Contact +41 61 324 1111
Novartis Investigator Site	Recruiting
Hyderabaad, India
Contact +41 61 324 1111
Novartis Investigator Site	Recruiting
Mangalore, India
Contact +41 61 324 1111
Novartis Investigator Site	Recruiting
Coimbatore, India
Contact +41 61 324 1111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSPP100A2110, CTRI/2009/091/000287, 26-06-2009
Study First Received:	July 3, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00933920 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Novartis:

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

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009