NCT02873208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
- 266
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Events
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agrees to use an acceptable method of contraception for the duration of the study
- •Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
- •Additional criteria may apply
排除标准
- •Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
- •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
Oral tablet, daily dosing
干预措施: ALKS 3831 (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events
时间窗: Up to 52 weeks
Overall summary of treatment emergent adverse events during the treatment period
次要结局
未报告次要终点
研究者
研究点 (1)
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