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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.
Information provided by:
Novartis Identifier:
First received: August 20, 2007
Last updated: October 5, 2010
Last verified: October 2010
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.

Condition Intervention Phase
Drug: Aliskiren
Drug: Aliskiren plus placebo
Phase 3

Novartis has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
Official Title: 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"

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: October 2005
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Various sequences of different doses of Aliskiren
Drug: Aliskiren
Other Name: 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 Name: SPP100
Experimental: 4
Various sequences of different doses of Aliskiren plus placebo
Drug: Aliskiren plus placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00518765

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Principal Investigator: Novartis Investigative site
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00518765     History of Changes
Other Study ID Numbers: CSPP100A2318
Study First Received: August 20, 2007
Last Updated: October 5, 2010

Keywords provided by Novartis:
aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on May 24, 2017