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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM087 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17664863 | Background | Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N; Conivaptan Study Group. Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27(5):447-57. doi: 10.1159/000106456. Epub 2007 Jul 26. | |
| 18034777 | Background | Verbalis JG, Zeltser D, Smith N, Barve A, Andoh M. Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: subgroup analysis of a randomized, controlled study. Clin Endocrinol (Oxf). 2008 Jul;69(1):159-68. doi: 10.1111/j.1365-2265.2007.03149.x. Epub 2008 Jul 1. |
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| Phoenix |
| Arizona |
| United States |
| Tuscon | Arizona | United States |
| La Jolla | California | United States |
| Los Angeles | California | United States |
| Santa Rosa | California | United States |
| Miami | Florida | United States |
| Plantation | Florida | United States |
| Springfield | Illinois | United States |
| Indianapolis | Indiana | United States |
| Shreveport | Louisiana | United States |
| Worchester | Massachusetts | United States |
| Petoskey | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Rolla | Missouri | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| New York | New York | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Columbia | South Carolina | United States |
| Sioux Falls | South Dakota | United States |
| Chattanooga | Tennessee | United States |
| Norfolk | Virginia | United States |
| Salem | Virginia | United States |
| Huntington | West Virginia | United States |
| Madison | Wisconsin | United States |
| Drummondville | Quebec | Canada |
| Montreal 2 Sites | Quebec | Canada |
| Ashkelon | Israel |
| Beersheba | Israel |
| Haifa 2 Sites | Israel |
| Holon | Israel |
| Jerusalem | Israel |
| Rehovot | Israel |
| Safed | Israel |
| Tel Aviv | Israel |
| Tel Litwinsky | Israel |
| Bloemfontein | South Africa |
| Buff | South Africa |
| Durban | South Africa |
| East London | South Africa |
| eManzimtoti | South Africa |
| Johannesburg | South Africa |
| Lyttelton Manor | South Africa |
| Port Elizabeth | South Africa |
| Pretoria | South Africa |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C106389 | conivaptan |
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