EUCTR2015-003880-13-HU进行中（未招募）1 期
A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects with Schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Alkermes Inc
- 入组人数
- 277
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
- •Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days
- •Agrees to use an acceptable method of contraception for the duration of the study
- •Additional criteria may apply
- •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 370
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Subject is currently taking medications that are contraindicated with olanzapine use
- •Subject has a positive test for drugs of abuse at study entry
- •Subject is pregnant, planning to become pregnant, or breastfeeding during the study
- •Additional criteria may apply
研究者
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