EUCTR2017-002840-34-AT进行中（未招募）1 期
An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Recordati AG
- 入组人数
- 200
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
- •1. Currently participating in a Global Novartis-sponsored osilodrostat study
- •2. Currently benefiting from treatment with osilodrostat, as determined by the Investigator
- •3. Demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements
- •4. Willingness and ability to comply with scheduled visits and treatment plans
- •5. Written informed consent obtained prior to enrolling into the roll-over study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study
- •2. Receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS
- •3. Pregnant or nursing women
- •4. Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping medication
研究者
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