Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
conivaptan · 7 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 |
| 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
Conivaptan is a small molecule being developed by Cumberland Pharmaceuticals Inc. for hyponatremia, a condition of low blood sodium. It is also studied in liver disease, chronic heart failure, kidney diseases, and liver cirrhosis. The drug is currently in Phase 2 clinical development for these indications.
Conivaptan is a vasopressin receptor antagonist, meaning it blocks the action of vasopressin, a hormone that regulates water balance in the body. By blocking these receptors, conivaptan increases water excretion, which helps raise blood sodium levels in patients with hyponatremia.
Conivaptan is developed by Cumberland Pharmaceuticals Inc., a biopharmaceutical company traded on NASDAQ under the ticker CPIX. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating hyponatremia and related conditions.
Conivaptan is in Phase 2 clinical development for liver disease, chronic heart failure, kidney diseases, liver cirrhosis, and hyponatremia. It is an investigational drug and has not been approved by the FDA for these uses. Clinical trials are ongoing to assess its safety and effectiveness.
Conivaptan has been studied in several completed clinical trials. NCT00379847 was a Phase 3 open-label study in 251 patients with hyponatremia. NCT00592475 was a Phase 2 study in 20 cirrhotic patients. NCT00851227 and NCT01370148 were Phase 1 studies in patients with liver impairment.
Yes, conivaptan is also known as YM087. In clinical trials, it has been referred to by both names. For example, NCT00379847, a study in patients with hyponatremia, was titled 'An Open-Label Study of YM087 (Conivaptan)'. This alternative name is used interchangeably in research literature.