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

NCT ID: NCT00933920

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Fed Group

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

Fasted group

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

Interventions

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Aliskiren

Intervention Type DRUG

Aliskiren

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Coimbatore, , India

Site Status

Novartis Investigative Site

Hyderabaad, , India

Site Status

Novartis Investigator Site

Hyderabaad, , India

Site Status

Novartis Investigator Site

Mangalore, , India

Site Status

Novartis Investigative Site

New Delhi, , India

Site Status

Countries

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India

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3763

Results for CSPP100A2110 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CTRI/2009/091/000287

Identifier Type: -

Identifier Source: secondary_id

26-06-2009

Identifier Type: -

Identifier Source: secondary_id

CSPP100A2110

Identifier Type: -

Identifier Source: org_study_id