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"
Sponsor study identifier
interventional
32
1 country
1
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2007
Actual (reported)Study Completion
Not reported
Date not reportedThis 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 2007
Actual (reported)August 20, 2007
Actual (reported)August 21, 2007
Actual (reported)Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
baseline and hourly intervals.
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
Various sequences of different doses of Aliskiren
Various sequences of different doses of Aliskiren plus placebo
Various sequences of different doses of Aliskiren
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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.
Novartis
Investigative site
32 participants (actual enrollment reported by the registry).
First Submitted
August 20, 2007
First Posted
August 21, 2007
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Various sequences of different doses of Aliskiren plus placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 2007
Actual (reported)Last Updated
October 6, 2010
Record last verified: 2010-10
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Source: ClinicalTrials.gov.
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