EUCTR2016-004947-35-Outside-EU/EEA进行中（未招募）1 期
An Open-Label Study To Evaluate The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial - Not applicable
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Eisai Inc.
- 入组人数
- 117
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
- •Diagnosis of Down syndrome (established during study E2020-A001-220).
- •Completion of study E2020-A001-219 (NCT00570128 [also known as A2501059]) with no ongoing serious adverse events and no severe drug reactions.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 117
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Weight less than 20 kilogram (kg).
- •Clinically significant conditions affecting absorption, distribution or metabolism of the study medication.
- •No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study.
- •Females of childbearing potential who are not practicing an effective means of birth control.
研究者
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