EUCTR2014-004092-23-PT进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •- 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.
研究者
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