NCT01939184已完成2 期
A Study to Assess the Safety and Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 796
- 试验地点
- 2
- 主要终点
- Change from Baseline in Total IPSS (International Prostate Symptom Score)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.
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 (Participant, Investigator)
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
- •History of LUTS for ≥6 months secondary to BPH
- •Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening
排除标准
- 未提供
研究组 & 干预措施
WC3055-01F
Experimental
WC3055 12.5 mg tablet once daily for 12 weeks
干预措施: WC3055 (Drug)
WC3055-02F
Experimental
WC3055 25 mg tablet once daily for 12 weeks
干预措施: WC3055 (Drug)
WC3055-03F
Experimental
WC3055 50 mg tablet once daily for 12 weeks
干预措施: WC3055 (Drug)
WC3055-04F
Experimental
WC3055 75 mg tablet once daily for 12 weeks
干预措施: WC3055 (Drug)
WC3055-07P
Placebo Comparator
Placebo tablet once daily for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change from Baseline in Total IPSS (International Prostate Symptom Score)
时间窗: Final Visit (Week 12 or final visit)
Sum of Questions 1-7.
次要结局
- Change from Baseline Total IPSS(Week 8)
- Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score(Week 4)
- Change from Baseline IIEF-EF Domain Score(Final Visit (Week 12 or Final Visit))
研究者
研究点 (2)
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