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"
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 21, 2007
CompletedOctober 6, 2010
October 1, 2010
1.8 years
August 20, 2007
October 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet
baseline and hourly intervals.
Secondary Outcomes (1)
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
Study Arms (4)
1
EXPERIMENTALVarious sequences of different doses of Aliskiren
2
EXPERIMENTALVarious sequences of different doses of Aliskiren plus placebo
3
EXPERIMENTALVarious sequences of different doses of Aliskiren
4
EXPERIMENTALVarious sequences of different doses of Aliskiren plus placebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects age 18 to 75 years of age included
- Strictly adhere to provided diet.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 18559696DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Investigative site
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 21, 2007
Study Start
October 1, 2005
Primary Completion
August 1, 2007
Last Updated
October 6, 2010
Record last verified: 2010-10