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A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Mild Renal Function Impaired Subjects | Experimental |
| |
| 2. Moderate Renal Function Impaired Subjects | Experimental |
| |
| 3. Subjects with Normal Renal Function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conivaptan hydrochloride | Drug | intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure PK and protein binding of conivaptan | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure safety and tolerability of conivaptan | 5 days |
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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 |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States |
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|
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C106389 | conivaptan |
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