NCT00366327终止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 Pfizer0 个研究点目标入组 400 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 主要终点
- Change in weight from baseline/first dose of bifeprunox at each observation.
研究概览
简要总结
An open-label extension study using a variable dose (20 to 30 mg daily) of bifeprunox to evaluate long-term safety.
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-
- •A signed and dated informed consent form for this study.
- •No major protocol violations in the previous study.
排除标准
- •Clinically important abnormalities in the preceding short-term study that have not resolved.
- •Use of prohibited treatments in the preceding short-term study.
- •Meeting any exclusion criteria in the preceding short-term study
研究组 & 干预措施
A
Experimental
干预措施: Bifeprunox (Drug)
结局指标
主要结局
Change in weight from baseline/first dose of bifeprunox at each observation.
时间窗: 1 year
次要结局
- Change from baseline/first dose of bifeprunox in trigyleride levels, Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impressions (CGI) score, and waist circumference at each observation.(1 year)
研究者
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