EUCTR2017-000175-86-Outside-EU/EEA进行中（未招募）1 期
A 52-Week, Open-label, Multicenter Study of the Safety and Tolerabilityof Aripiprazole Flexibly Dosed in the Treatment of Children andAdolescents with Autistic Disorder
Otsuka Pharmaceutical Development & Commercialization,0 个研究点目标入组 330 人开始时间: 2017年4月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
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
- •This was an open-label, multicenter safety investigation of aripiprazole,
- •flexibly dosed, in children and adolescents with a diagnosis of AD.
- •Subjects who
- •completed either of the antecedent double-blind, parallel-group studies
- •of aripiprazole in
- •comparison to placebo (protocols CN138178 or CN138179) were
- •eligible to enter this
- •52-week trial, provided that continuation of treatment was clinically
- •warranted, as judged
- •by the investigator, and there were no clinically relevant AEs that
- •would preclude
- •inclusion in the trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Adverse Events
- •Non-participation in Parent Studies
研究者
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