Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00933920
First received: July 3, 2009
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

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 ]

Enrollment: 124
Study Start Date: June 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fed Group Drug: Aliskiren
Active Comparator: Fasted group 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

Locations
India
Novartis Investigator Site
Coimbatore, India
Novartis Investigative Site
Hyderabaad, India
Novartis Investigator Site
Hyderabaad, India
Novartis Investigator Site
Mangalore, India
Novartis Investigative Site
New Delhi, India
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00933920     History of Changes
Other Study ID Numbers: CSPP100A2110, CTRI/2009/091/000287, 26-06-2009
Study First Received: July 3, 2009
Last Updated: February 3, 2010
Health Authority: India: Ministry of Health

Keywords provided by Novartis:
Aliskiren,
hypertension,
renin-angiotensin-aldosterone system,
pharmacokinetics,
pharmacodynamics

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013