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| Name | Class |
|---|---|
| Cardiokine Biopharma, LLC | INDUSTRY |
| Biogen | INDUSTRY |
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia
Phase I and Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, LCWA and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in patients with hyponatremia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CK-LX3401 | Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia. | ||
| CK-LX3405 | Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia | ||
| CK-LX3430 | Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials. | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that after open-label lixivaptan treatment: improvements in the time to complete the TMT-B will be maintained compared to baseline, and improvements in the Medical Outcomes Survey will be maintained compared to baseline. | 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia (CK-LX3401, CK-LX3405, or CK-LX3430)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Torrance Clinical Research | Lomita | California | 90717 | United States | ||
| Innovative Research of West Florida |
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| Clearewater |
| Florida |
| 33756 |
| United States |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Millenium Psychiatric Associates, LLC | Creve Cour | Missouri | 63141 | United States |
| Internal Medical Associates of Grand Island, PC | Grand Island | Nebraska | 68803 | United States |
| ID | Term |
|---|---|
| D007177 | Inappropriate ADH Syndrome |
| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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