Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00358878 | Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS) | PHASE3 | COMPLETED | 463 | — | — | Jul 1, 2006 | Dec 1, 2008 | May 26, 2016 | 21 | United States, Argentina +19 |
| NCT00501384 | Satavaptan Dose-Ranging Study in the Prevention of Ascites | PHASE2 | COMPLETED | 151 | — | — | Apr 1, 2004 | May 1, 2005 | Jan 12, 2009 | 11 | Argentina, Australia +9 |
| NCT00501566 | Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites | PHASE2 | COMPLETED | 148 | — | — | Apr 1, 2004 | Jan 1, 2005 | Jul 16, 2007 | 12 | Argentina, Australia +10 |
| NCT00501722 | Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites | PHASE2 | COMPLETED | 110 | — | — | Apr 1, 2004 | Mar 1, 2005 | Jan 12, 2009 | 13 | United States, Argentina +11 |
| Arm | Type | Description |
|---|---|---|
| Satavaptan | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Satavaptan | DRUG | oral administration once daily |
| placebo | DRUG | oral administration once daily |
| satavaptan (SR121463B) | DRUG | - |
Inclusion Criteria: * Participants with cirrhosis of the liver * Participants with clinically evident ascites primarily managed by diet and/or diuretics * Stable treatment of ascites for at least the previous 2 weeks without paracentesis * Participants having undergone no more than one therapeutic ...