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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
  Purpose

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
Hypertension
 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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518765

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00518765     History of Changes
Other Study ID Numbers: CSPP100A2318
Study First Received: August 20, 2007
Last Updated: October 5, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Captopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013