Clinical trial
A Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients With Endogenous Cushing's Syndrome
Name
LCI699-RECAG-PASS-0572
Description
This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome
Trial arms
Trial start
2022-06-13
Estimated PCD
2028-06-01
Trial end
2029-02-01
Status
Recruiting
Treatment
Osilodrostat
oral administration of Osilodrostat tablets at different doses according to patient's need
Arms:
Osilodrostat
Other names:
Isturisa
Size
100
Primary endpoint
Incidence of osilodrostat-related adverse events and serious adverse events
3 years of treatment with osilodrostat
Eligibility criteria
Inclusion Criteria:
* Written informed consent obtained prior to registration of any patient data
* Male or female patients aged 18 years or older with endogenous CS treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening.
Exclusion Criteria:
* Patients with exogenous CS
* Patients with Pseudo CS
* Patients participating in an interventional clinical trial with an investigational drug.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-08-22
1 organization
Organization
Recordati Group