At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 94 enrolled
Drug / intervention
Levoketoconazoledrug
Likely dose
Not stated in 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.
An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome
In Brief
A Phase 3 clinical trial evaluating Levoketoconazole for Endogenous Cushing's Syndrome. Completed, enrolled 94 participants across 42 sites in 15 countries.
Detailed Summary
The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndogenous Cushing's Syndrome
CountriesBelgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Serbia, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartAug 2014
Primary CompletionApr 2018
Study CompletionNov 2018
TodayJul 2026
First PostedApr 24, 2013
Enrollment StartAug 1, 2014
Primary CompletionApr 1, 2018
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.2 years ago
Interventions
Levoketoconazoledrug
Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole