临床试验/NCT00366704

NCT00366704终止3 期

A Multicenter, Randomized, Double-blind, Parallel-group Fixed-dose Study of the Effect on Weight of Bifeprunox Versus Risperidone 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: 2006年11月最近更新: 2013年2月11日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方
入组人数: 400
主要终点: The primary analysis will be the change from baseline on body weight at the final evaluation.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of 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: 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

B

Active Comparator

干预措施: risperidone (Drug)

A

Experimental

干预措施: bifeprunox (Drug)

结局指标

主要结局

The primary analysis will be the change from baseline on body weight at the final evaluation.

时间窗: 8 weeks

次要结局

Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.(8 weeks)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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