Clinical trial: Safety and Efficacy of LCI699 in Cushing's Disease Patients (NCT01331239)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with a confirmed diagnosis of Cushing's Disease (persistent or recurrent) as
             evidenced by increased 24-hour urine free cortisol (UFC), normal or increased morning
             plasma Adrenocorticotropic Hormone (ACTH), and pituitary origin of excess ACTH.

          -  Patients with de novo Cushing's disease can be included only if they are not
             considered candidate for surgery

        Exclusion Criteria:

          -  Patients treated with mitotane 6 months prior to Visit 1

          -  Patients with compression of the optic chiasm

          -  Patients with a known inherited syndrome as the cause for hormone over secretion

          -  Patients with Cushing's syndrome due to ectopic ACTH secretion or adrenal Cushing's
             syndrome

          -  Patients with pseudo-Cushing's syndrome

          -  Patients who are not biochemically euthyroid

          -  Diabetic patients with poorly controlled diabetes (HbA1c >9%)

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using highly effective methods of contraception
             during dosing and for 1 week after completion of dosing.

          -  Patients who have received pituitary irradiation within five years prior to Visit 1.

          -  Patients with risk factors for QTc prolongation or Torsade de Pointes.
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.
Subject must be at most 75 Years

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