Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet
NCT ID: NCT00518765
Last Updated: 2010-10-06
Study Results
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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COMPLETED
PHASE3
32 participants
INTERVENTIONAL
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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1
Various sequences of different doses of Aliskiren
Aliskiren
2
Various sequences of different doses of Aliskiren plus placebo
Aliskiren plus placebo
3
Various sequences of different doses of Aliskiren
Aliskiren
4
Various sequences of different doses of Aliskiren plus placebo
Aliskiren plus placebo
Interventions
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Aliskiren
Aliskiren plus placebo
Aliskiren
Aliskiren plus placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Strictly adhere to provided diet.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Investigative site
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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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. doi: 10.1161/CIRCULATIONAHA.108.767202. Epub 2008 Jun 16.
Other Identifiers
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CSPP100A2318
Identifier Type: -
Identifier Source: org_study_id