At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
osilodrostatdrug
Likely dose
osilodrostat 1mgfrom 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, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat
In Brief
A Phase 2 clinical trial evaluating osilodrostat for Cushing's Syndrome. Completed, enrolled 127 participants across 56 sites in 21 countries.
Detailed Summary
The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing's Syndrome
CountriesArgentina, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, France, Germany, India, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartOct 2018
Primary CompletionNov 2023
TodayJul 2026
First PostedJul 30, 2018
Enrollment StartOct 5, 2018
Primary CompletionNov 16, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 7.9 years ago
Interventions
osilodrostatdrug
osilodrostat, in the form of film coated tablets for oral administration, in the following tablet strengths: 1mg, 5mg, 10mg. Each strength has unique tablet size, colour and imprint.