Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome (NCT02468193) | Clinical Trial Compass
CompletedPhase 2
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
Japan9 participantsStarted 2015-09-24
Plain-language summary
The study aim was to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Patients with confirmed Cushing's syndrome \[i.e. ectopic corticotropin syndrome, adrenal adenoma, adrenal carcinoma, ACTH-Independent Macronodular Adrenal Hyperplasia (AIMAH), or Primary Pigmented Nodular Adrenal Dysplasia (PPNAD)\]
* For patients on medical treatment for hypercortisolism due to Cushing's syndrome, the washout periods had to be completed prior to baseline efficacy assessments
Exclusion Criteria:
* Patients with Cushing's disease
* History of hypersensitivity to osilodrostat or to drugs of similar chemical classes
* History of malignancy of any organ system, treated or untreated, within the past 5 years
* Patients receiving treatment for within 4 weeks or ≤5 x half-life of the agent (whichever is longer) before first dose of osilodrostat
* Patients with risk factors for QTc prolongation or Torsade de Pointes
What they're measuring
1
Percent Change in the Mean Urine Free Cortisol (mUFC) at the Individual Level at Week 12