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Clinical Trial Summary

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


Clinical Trial 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. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. Patients with endogenous Cushing's Syndrome who are treated with osilodrostat alone or in combination with other therapies will be considered eligible for study enrolment. Each patient enrolled in the study will be followed up for 3 years from study entry. Patients who discontinue prior to the end of the 3-year period will be followed-up for 3 months after discontinuation of osilodrostat and will be included in the analysis. The total number of patients enrolled in this study will be at least 100. Assuming a recruitment period of 3 years, the total study duration from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) will be 6 years. The maximum duration for the individual patient is 3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05382156
Study type Observational
Source RECORDATI GROUP
Contact Julia Stermenska
Phone +41 79 440 58 97
Email stermenska.j@recordati.com
Status Recruiting
Phase
Start date June 13, 2022
Completion date February 2029

See also
  Status Clinical Trial Phase
Completed NCT03277690 - A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. Phase 3
Completed NCT03880513 - Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)
Completed NCT01838551 - Treatment for Endogenous Cushing's Syndrome Phase 3