NCT00044005已完成2 期
A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 26
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lurasidone 20 mg
Experimental
Lurasidone 20 mg oral tablet
干预措施: Lurasidone 20 mg (Drug)
Lurasidione 40 mg
Experimental
Lurasidone 40 mg oral tablet
干预措施: Lurasidone 40 mg (Drug)
Lurasidone 80mg
Experimental
Lurasidone 80mg oral tablet
干预措施: Lurasidone 80mg (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 6-months
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
次要结局
未报告次要终点
研究者
研究点 (26)
Loading locations...
相似试验
已完成
3 期
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With SchizophreniaSchizophreniaNCT01614912Sumitomo Pharma Co., Ltd.284
已完成
3 期
Study of SM-13496 (Lurasidone HCl) in Patients With SchizophreniaSchizophreniaNCT00711269Sumitomo Pharma Co., Ltd.460
已完成
3 期
A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With SchizophreniaSchizophreniaNCT01614899Sumitomo Pharma Co., Ltd.457
暂停
1 期
Safety, Tolerability, and Pharmacokinetics of APN1125 in Subjects With SchizophreniaSchizophreniaNCT02724917CoMentis30
已完成
3 期
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.Bipolar I DisorderNCT01986114Sumitomo Pharma Co., Ltd.495