EUCTR2016-003694-18-HU进行中（未招募）1 期
A double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) A 12 weeks open label extension
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Saniona A/S
- 入组人数
- 35
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
入选标准
- •Patient must meet all of the following inclusion criteria in order to be eligible for the study:
- •All male and female pediatric subjects with confirmed diagnosis of PWS who completed the double blind phase (12 weeks) will be invited to participate in the open label 12 weeksextension phase, if deemed eligible by the Investigators.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •If subject/parents decide not to participate in the OLE, subject will finish the study based on the Protocol Amendment 1.4.
研究者
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