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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Various sequences of different doses of Aliskiren |
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| 2 | Experimental | Various sequences of different doses of Aliskiren plus placebo |
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| 3 | Experimental | Various sequences of different doses of Aliskiren |
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| 4 | Experimental | Various sequences of different doses of Aliskiren plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug |
|
| |
| Aliskiren plus placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Renal plasma flow following 3 single doses of aliskiren in healthy volunteers on a low sodium(10 mEq/day)diet | baseline and hourly intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigative site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18559696 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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| Drug |
|
| Aliskiren | Drug |
|
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| Aliskiren plus placebo | Drug |
|