Overview

Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome

Status:
Completed

Trial end date:
2018-10-29

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Criteria

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