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A roll-over Study in Patients With Endogenous Cushing's Syndrome

Phase 4
Completed
Conditions
Cushing's syndrome
Registration Number
JPRN-jRCT2080224109
Lead Sponsor
Recordati Rare Diseases Japan K.K
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
180
Inclusion Criteria

Primary inclusion criteria
- Patients who have completed a Global Novartis-sponsored study receiving osilodrostat.
- Patients who will continue to benefit from treatment with osilodrostat, as judged by the investigator.
- Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
- Willingness and ability to comply with scheduled visits and treatment plans.
- Written informed consent obtained prior to enrolling into the roll-over study .

Exclusion Criteria

Primary exclusion criteria
- Patients who have been permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study.
- Patients who are receiving osilodrostat in combination with unapproved or experimental treatments.
- Pregnant or nursing (lactating) women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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