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Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

NCT03606408 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-12-18

Study results available
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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.

Conditions

Interventions

DRUG

osilodrostat

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.

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Recordati · Recordati AG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-05
Primary Completion
2023-11-16
Completion
2023-11-16
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Costa Rica
  • France
  • Germany
  • India
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606408 on ClinicalTrials.gov