NCT01626872已完成2 期
Long-Term Extension Study of MP-214 in Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 3
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the patient before the completion of Study A002-A4
- •Patients who have completed the A002-A4 study
排除标准
- •Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)
- •The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
MP-214 3mg
Experimental
干预措施: MP-214 3mg (Drug)
MP-214 6mg
Experimental
干预措施: MP-214 6mg (Drug)
MP-214 9mg
Experimental
干预措施: MP-214 9mg (Drug)
Risperidone 4mg
Active Comparator
干预措施: Risperidone 4mg (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
The Numbers show Subjects with at least one Adverse Event
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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