At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 73 enrolled
Drug / intervention
osilodrostat +1 moredrug
Likely dose
osilodrostat 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease
In Brief
A Phase 3 clinical trial evaluating osilodrostat and osilodrostat Placebo for Cushing's Disease. Completed, enrolled 73 participants across 36 sites in 14 countries.
Detailed Summary
The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing's Disease
CountriesBelgium, Brazil, Canada, China, Costa Rica, Greece, Poland, Portugal, Russia, Spain, Switzerland, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartOct 2016
Primary CompletionJun 2019
Study CompletionDec 2020
TodayJul 2026
First PostedMar 3, 2016
Enrollment StartOct 3, 2016
Primary CompletionJun 19, 2019
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.3 years ago
Interventions
osilodrostatdrug
In the form of filmcoated tablets for oral administration, in the following dose strengths: 1 mg, 5 mg, 10 mg, and 20 mg.
osilodrostat Placebodrug
Matching Placebo in the form of filmcoated tablets for oral administration