NCT00143377已完成4 期
A Global Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial To Evaluate The Effectiveness Of Detrusitol Sr 4mg On Patient's Perception Of Bladder Condition (PPBC).
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 600 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder and which of these bothersome symptoms are improved with treatment.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older patients suffering from OAB symptoms (urinary frequency of at least 8 micturitions per 24h, urinary urgency and at least 3 urge urinary incontinence episodes within 3 days), confirmed by a micturition bladder diary.
排除标准
- •Other than urge incontinence
- •History of prostate/uterine or other female organ cancer
结局指标
主要结局
Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.
次要结局
- Other safety and efficacy measures at 12 weeks of treatment.
研究者
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