NCT00333112已完成4 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Frequency in Men VICTOR: VESIcare® In Combination With Tamsulosin in OAB Residual Symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 398
- 主要终点
- Change in micturitions per 24 hours from baseline to end of treatment
研究概览
简要总结
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
详细描述
A 2 arm study ( 1 Active, 1 Placebo) to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Symptoms of Overactive Bladder (OAB)
排除标准
- •Current use of antimuscarinic therapy
- •Evidence of a urinary tract infection
研究组 & 干预措施
1
Experimental
干预措施: solifenacin succinate (Drug)
1
Experimental
干预措施: tamsulosin (Drug)
2
Placebo Comparator
干预措施: tamsulosin (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in micturitions per 24 hours from baseline to end of treatment
时间窗: 18 weeks
次要结局
- Change in urgency episodes per 24 hours from baseline to end of treatment(18 weeks)
研究者
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