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Also known as YM087 oral, conivaptan, Vaprisol, conivaptan hydrochloride
YM087 · 9 trials · 5 indications
Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1. Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment. Change is calculated as Hour 48 - Baseline.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
Change from baseline is calculated as time point minus baseline. Baseline procedures were performed prior to study drug administration.
| Arm | Type | Description |
|---|---|---|
| Regimen 1 Conivaptan QD | EXPERIMENTAL | 20 mg conivaptan once a day |
| Regimen 2 Conivaptan BID | EXPERIMENTAL | 20 mg conivaptan two times a day |
| Regimen 3 Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Lower dose |
| 2 | EXPERIMENTAL | Higher dose |
| Regimen 1 Conivaptan 12.5 mg | EXPERIMENTAL | Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours |
| Regimen 2 Conivaptan 25 mg | EXPERIMENTAL | Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours |
| 3 | EXPERIMENTAL | Middle dose |
| 4 | EXPERIMENTAL | High dose |
| Subjects with severe hepatic impairment | EXPERIMENTAL | - |
| Subjects with normal hepatic function | ACTIVE_COMPARATOR | - |
| 1. Mild Renal Function Impaired Subjects | EXPERIMENTAL | - |
| 2. Moderate Renal Function Impaired Subjects | EXPERIMENTAL | - |
| 3. Subjects with Normal Renal Function | EXPERIMENTAL | - |
| 1. Mildly Hepatic Impaired Subjects | EXPERIMENTAL | - |
| 2. Moderately Hepatic Impaired Subjects | EXPERIMENTAL | - |
| 3. Subjects with Normal Hepatic Function | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Conivaptan | DRUG | premix bag |
| Placebo | DRUG | premix bag |
| YM087 | DRUG | - |
| YM087 oral | DRUG | - |
| conivaptan hydrochloride | DRUG | Intravenous |
Inclusion Criteria: * Euvolemic or hypervolemic (edematous) based on clinical presentation * Serum sodium between 115 and 130mEq/L at baseline Exclusion Criteria: * Clinical presentation of volume depletion or dehydration
YM087 is being developed for the treatment of hyponatremia, a condition in which blood sodium levels are abnormally low. The clinical program has focused on patients with euvolemic or hypervolemic hyponatremia, meaning low sodium without volume depletion. YM087 is an investigational small molecule and has not been approved for commercial use.
YM087 is being developed by Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company that trades on the Nasdaq under the ticker CPIX. Cumberland is the sponsor of the YM087 clinical program in hyponatremia. The drug remains investigational, and no marketing approval has been granted for it.
YM087 has completed Phase 3 clinical development for hyponatremia. Two Phase 3 trials have been conducted, and both are now listed as completed. Because the program is still investigational, YM087 is not approved by the FDA or any other regulatory agency for hyponatremia or any other indication.
YM087 has been evaluated in two completed Phase 3 trials in hyponatremia. NCT00492037 tested oral YM087 in patients with euvolemic or hypervolemic hyponatremia across nine European countries, enrolling 83 participants. NCT00380575 tested intravenous YM087 in the same patient population across the United States, Canada, Israel, and South Africa, enrolling 84 participants.
Yes, YM087 oral is an alternative name for YM087, referring to the orally administered formulation studied in the hyponatremia program. The same compound has also been tested in an intravenous formulation. Both formulations were evaluated in separate completed Phase 3 trials, and neither is approved for use.
The YM087 clinical program enrolled a total of 167 patients across its two completed Phase 3 trials in hyponatremia. NCT00492037 enrolled 83 participants and NCT00380575 enrolled 84 participants. Both studies were randomized, double-blind, and included adults aged 18 years and older.