Clinical trial: An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome (NCT00936741)

Eligibility criteria:
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 at Entry.

          -  Women of childbearing potential must be willing to use non-hormonal, medically
             acceptable methods of contraception during the study.

          -  Are able to provide written informed consent

          -  Are able to return to the investigative site to complete the study evaluations
             outlined in the protocol.

          -  Will not use systemic estrogens during the study.

        Exclusion Criteria:

          -  Have an acute or unstable medical problem, which could be aggravated by mifepristone
             treatment.

          -  Are taking medications within 14 days of the Entry visit that a) have a large first
             pass metabolism that is largely mediated by CYP3A4 and which have 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) other than
             CORLUX (mifepristone) within 30 days of Entry

          -  Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)

          -  Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone
             or eplerenone is allowed to control hypokalemia.

          -  Postmenopausal women with a history of endometrial hyperplasia with atypia or
             pathological features consistent with endometrial carcinoma.

          -  Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved
             after induction of menstrual bleeding with progesterone.

          -  Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.

          -  Any woman with an intact uterus who has a hemorrhagic disorder or is being treated
             with an anticoagulant (e.g. warfarin, heparin).

          -  Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.

          -  Elevated total bilirubin >1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? Contradiction