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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00936741 | An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome | PHASE3 | COMPLETED | 30 | — | — | Jul 1, 2009 | Sep 1, 2012 | Apr 2, 2014 | 15 | United States |
| NCT00569582 | A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome | PHASE3 | COMPLETED | 50 | — | — | Dec 1, 2007 | - | Aug 22, 2013 | 17 | United States |
Subjects who received at least one dose of mifepristone were included in the safety analysis.
Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.
Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.
| Arm | Type | Description |
|---|---|---|
| Mifepristone | EXPERIMENTAL | Mifepristone 300mg to 1200mg once daily |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mifepristone | DRUG | Mifepristone 300 mg to 1200 mg once daily |
Inclusion Criteria: * Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582). * In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone. * Women of childbearing potential have a negative serum pregnancy test ...