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| ID | Type | Description | Link |
|---|---|---|---|
| 127 | |||
| 2009_554 |
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This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Aliskiren 600 mg |
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| 2 | Active Comparator | Aliskiren 150 mg |
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| 3 | Active Comparator | Losartan 100 mg |
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| 4 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Single dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period. |
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| Measure | Description | Time Frame |
|---|---|---|
| change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren | 2-5 hours post dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan | 2-5 hours post dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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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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| Aliskiren | Drug | Single dose of one 150 mg tablet of Aliskiren in one of three study periods. There will be at least 10 days between each study period. |
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| Comparator: Losartan | Drug | Single dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period. |
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| Comparator: Placebo to Aliskiren | Drug | Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period. |
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| Comparator: Placebo to Losartan | Drug | Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period. |
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