NCT00366171已完成3 期
An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Bifeprunox in the Treatment of Outpatients With Schizophrenia.
Wyeth is now a wholly owned subsidiary of Pfizer83 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 83
- 主要终点
- Change in body weight from baseline/first dose of bifeprunox at each observation.
研究概览
简要总结
A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients who have successfully completed Wyeth study 3168A1-311-US.
- •A signed and dated informed consent form for this study.
- •No major protocol violations in previous study.
排除标准
- •Clinically important abnormalities noted in preceding short-term study that have not resolved.
- •Use of prohibited treatments in the preceding short-term study.
- •Meeting any exclusion criteria for the preceding short-term study.
结局指标
主要结局
Change in body weight from baseline/first dose of bifeprunox at each observation.
次要结局
- Change from baseline/first dose of bifeprunox for triglyceride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression (CGI)-Score, and waist circumference at each observation.
研究者
研究点 (83)
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