A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome

Exclusion Criteria

• •Have de novo Cushing's disease and are surgical candidates for pituitary surgery.
• •Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
• •Taking medications within 14 days of the baseline visit (Day 1) that a) have a large first pass metabolism largely mediated by CYP3A4 and a narrow therapeutic margin and/or b) are strong CYP3A4 inhibitors.
• •Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study.
• •Have received investigational treatment (drug, biological agent or device) within 30 days of Screening
• •Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
• •Have a non-endogenous source of hypercortisolemia such as factious hypercortisolemia (exogenous source of glucocorticoid, iatrogenic Cushing's syndrome), factious or therapeutic use of ACTH
• •Have Pseudo-Cushing's syndrome.
• •Receive PPARgamma agonist drugs (e.g. pioglitazone, rosiglitazone) within 4 months of Baseline (Day 1).
• •Postmenopausal women with an intact uterus who have experienced unexplained vaginal bleeding within 12 months of Screening are excluded.
• •Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.