Clinical trial: A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease (NCT00088608)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with pituitary Cushing's disease within the two months prior to study entry

          -  Patients for whom written informed consent to participate in the study has been
             obtained

          -  Female patients of child bearing potential who have not undergone clinically
             documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use
             barrier contraception throughout the course of the study, and for one month after the
             study has ended

        Exclusion Criteria:

          -  Female patients who are pregnant or lactating

          -  Patients who have been previously treated with certain medications may be required to
             be without certain medications prior to entering the study

          -  Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or
             HgbA1C > 10

          -  Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or
             history of acute MI less than one year prior to the study entry or clinically
             significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg
             or greater)

          -  Patients with chronic liver disease

          -  Patients with clotting disorders or abnormal blood counts

          -  History of immuno-compromise, including a positive HIV test result

          -  Patients with active gall bladder disease

          -  Patients who have participated in any clinical investigation with an investigational
             drug within 1 month prior to dosing

          -  Patients with active malignant disease (with the exception of basal cell carcinoma or
             carcinoma in situ of the cervix)
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 80 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? Entailment