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| ID | Type | Description | Link |
|---|---|---|---|
| 2010P001281 | Other Identifier | Partners Healthcare System |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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The objective of the study is to determine the magnitude of the effect of direct renin inhibition by VTP-27999 on renal plasma flow and kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VTP-27999 | Experimental |
| |
| aliskiren | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren | Drug | single dose, tablet |
|
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| Measure | Description | Time Frame |
|---|---|---|
| renal plasma flow | as measured by PAH clearance | pre-dose to 6 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| glomerular filtration rate | pre-dose to 6 hours post-dose | |
| RAAS pathway biomarkers | renin, prorenin, plasma renin activity, ang II | pre-dose to 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman K Hollenberg, MD, PhD | Brigham and Women's Hospital, Boston, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Barkoudah E, Danser AHJ, van Thiel BS, Fisher NDL, Gregg R, Hollenberg NK. Journal of the American Society of Hypertension 9(4) | ||
| 26882043 | Result | Barkoudah E, van Thiel BS, Fisher ND, Gregg RA, Danser AH, Moukarbel GV, Hollenberg NK. Maximum renal responses to renin inhibition in healthy study participants: VTP-27999 versus aliskiren. J Hypertens. 2016 May;34(5):935-41. doi: 10.1097/HJH.0000000000000860. |
| Label | URL |
|---|---|
| maximum renal responses in healthy study participants: VTP-27999 versus aliskiren | View source |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| C582069 | methyl (2-((3-chlorophenyl)(1-((2-(methylamino)-3-(tetrahydro-2H-pyran-3-yl)propyl)carbamoyl)piperidin-3-yl)methoxy)ethyl)carbamate |
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| placebo | Drug | single dose, tablet |
|
| VTP-27999 | Drug | single dose, tablet |
|
| VTP-27999 concentrations | pre-dose to 24 hours post-dose |