NCT00368706已完成3 期
A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 246
- 主要终点
- Change from baseline in mean number of micturitions per 24 hours
研究概览
简要总结
To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing and able to complete the micturition diary correctly
- •Patients experiencing frequency of micturition as verified in the diary
- •Patients experiencing significant post void residual volume
- •OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.
排除标准
- •Significant post void residual volume
- •Patients with indwelling catheters or practicing intermittent self- catheterization
- •Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose
研究组 & 干预措施
1
Experimental
干预措施: solifenacin succinate (Drug)
2
Active Comparator
干预措施: tolterodine (Drug)
结局指标
主要结局
Change from baseline in mean number of micturitions per 24 hours
时间窗: 8 Weeks
次要结局
- Change from baseline in mean volume voided per micturition(8 Weeks)
- Change from baseline in mean number of incontinence episodes per 24 hours(8 Weeks)
- Change from baseline in mean urgency frequency per 24 hours(8 Weeks)
- Change from baseline in mean nocturia episodes per 24 hours(8 Weeks)
研究者
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