NCT02669758已完成3 期
A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
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.
研究组 & 干预措施
ALKS 3831
Experimental
Olanzapine + samidorphan; administered as a coated bilayer tablet.
干预措施: ALKS 3831 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 52 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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