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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00518765
First received: August 20, 2007
Last updated: October 5, 2010
Last verified: October 2010
History of Changes

August 20, 2007
October 5, 2010
October 2005
August 2007   (final data collection date for primary outcome measure)
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. ]
Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet;baseline,hourly intervals.
Complete list of historical versions of study NCT00518765 on ClinicalTrials.gov Archive Site
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 ]
Single dose application of aliskiren on renal hemodynamics and circulating markers of the renin pathway; baseline, and at 5 hours, and 24 hours post dose
Not Provided
Not Provided
 
Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Hypertension
  • Drug: Aliskiren
    Other Name: SPP100
  • Drug: Aliskiren plus placebo
  • Experimental: 1
    Various sequences of different doses of Aliskiren
    Intervention: Drug: Aliskiren
  • Experimental: 2
    Various sequences of different doses of Aliskiren plus placebo
    Intervention: Drug: Aliskiren plus placebo
  • Experimental: 3
    Various sequences of different doses of Aliskiren
    Intervention: Drug: Aliskiren
  • Experimental: 4
    Various sequences of different doses of Aliskiren plus placebo
    Intervention: Drug: Aliskiren plus placebo
Fisher ND, Jan Danser AH, Nussberger J, Dole WP, Hollenberg NK. Renal and hormonal responses to direct renin inhibition with aliskiren in healthy humans. Circulation. 2008 Jun 24;117(25):3199-205. Epub 2008 Jun 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00518765
CSPP100A2318
No
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Investigative site
Novartis
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP