EUCTR2014-004092-23-PL
Active, not recruiting
Phase 1
A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cushing's disease
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 74
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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