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

December 17, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Coimbatore, India
        • Novartis Investigator Site
      • Hyderabaad, India
        • Novartis Investigative Site
      • Hyderabaad, India
        • Novartis Investigator Site
      • Mangalore, India
        • Novartis Investigator Site
      • New Delhi, India
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the effect of Plasma Renin Concentration (PRC) and angiotensin II of aliskiren when given with and without light meal
Time Frame: 28 Days
28 Days
Assess safety and tolerability of aliskiren when given with and without light meal
Time Frame: 28 days
28 days
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 3, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (Estimate)

July 7, 2009

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPP100A2110
  • CTRI/2009/091/000287
  • 26-06-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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