EUCTR2007-005237-10-DE进行中（未招募）不适用
A twenty-six weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed clinical trial protocol 21106. - Aquamarine
V Organon0 个研究点目标入组 211 人开始时间: 2008年9月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 211
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
- •Subjects are eligible to participate in the trial, if they:
- •1. sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
- •2. completed trial 21106 i.e. completed 26 weeks of treatment and finished the 7-day discontinuation period
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Potential participants will be excluded if they have experienced any of the following during trial 21106:
- •3. any adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106 as judged by the investigator;
- •4. were significantly non compliant with protocol criteria and procedures of trial 21106, as judged by the investigator;
- •5. pregnancy
研究者
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