Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease

Phase 1

• Conditions: Cushing's disease; MedDRA version: 20.0Level: LLTClassification code 10011651Term: Cushing's diseaseSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-004092-23-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-25
• Study Completion: 2020-12-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Male or female patients aged 18 - 75 years
Confirmed CD that is persistent or recurrent
For patients with a history of pituitary irradiation: at least 2 years since stereotactic radiosurgery (SRS), and 3 years since conventional (fractionated) radiation
Able to communicate well with the investigator, to understand and comply with the requirements of the study
Washout of any current drug therapy for CD
Additional inclusion criteria as per full protocol may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

- Use of other investigational drugs at the time of enrollment
- Pseudo-Cushing’s syndrome
- History of malignancy of any organ system
- Risk factors for QTc prolongation or Torsade de Pointes
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using highly effective methods of contraception
Additional exclusion criteria as per full protocol may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified