Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet

October 5, 2010 updated by: Novartis

A Single-center, Placebo-controlled Study of the Effects of Ascending Single Oral Doses of Aliskiren Compared With Captopril on Renal Hemodynamics in Healthy Volunteers on a Low and High Sodium Diet "Renin Inhibition and the Kidney"

This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female subjects age 18 to 75 years of age included
  • Strictly adhere to provided diet.

Exclusion Criteria:

  • Symptomatic low blood pressure
  • Prescription medications, including those for blood pressure control, birth control pills, and any other medication that could affect kidney function
  • Over-the-counter medication 2 weeks before study start
  • Clinically significant heart abnormalities.
  • Previous history of allergy to the study drug or drugs similar to the study drug.
  • Any surgical or medical condition which might significantly alter the action of a drug (for example, absorption, distribution, metabolism or excretion) or which may jeopardize the subject in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria 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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Various sequences of different doses of Aliskiren
Drug: Aliskiren
Other Names:
  • SPP100
Experimental: 2
Various sequences of different doses of Aliskiren plus placebo
Drug: Aliskiren plus placebo
Experimental: 3
Various sequences of different doses of Aliskiren
Drug: Aliskiren
Other Names:
  • SPP100
Experimental: 4
Various sequences of different doses of Aliskiren plus placebo
Drug: Aliskiren plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
Time Frame: baseline and hourly intervals.
baseline and hourly intervals.

Secondary Outcome Measures

Outcome Measure
Time Frame
Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway
Time Frame: baseline, and at 5 hours, and 24 hours post dose
baseline, and at 5 hours, and 24 hours post dose

Collaborators and Investigators

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

Sponsor

Novartis

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.

General Publications

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

October 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2010

Last Update Submitted That Met QC Criteria

October 5, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPP100A2318

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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