Endogenous Cushing Syndrome
Conditions
Brief summary
Incidence of treatment-emergent adverse events (TEAEs) (assessed monthly): TEAEs, serious TEAEs (SAEs), treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment., Changes from Baseline in clinical laboratory tests (hematology and chemistry panels)., Changes from Baseline in physical examinations and vital sign measurements., Changes from Baseline in electrocardiograms (ECGs) (12-lead) (including QTcF interval, QRS complex, PR interval, and heart rate)., Changes from Baseline in pituitary tumors based on magnetic resonance imaging (MRI) scans in patients with Cushing disease.
Interventions
None listed
Sponsors
Corcept Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) (assessed monthly): TEAEs, serious TEAEs (SAEs), treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment., Changes from Baseline in clinical laboratory tests (hematology and chemistry panels)., Changes from Baseline in physical examinations and vital sign measurements., Changes from Baseline in electrocardiograms (ECGs) (12-lead) (including QTcF interval, QRS complex, PR interval, and heart rate)., Changes from Baseline in pituitary tumors based on magnetic resonance imaging (MRI) scans in patients with Cushing disease. | — |
Countries
Austria, Bulgaria, Germany, Italy, Netherlands, Poland, Romania, Spain
Outcome results
None listed