A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 919
- 主要终点
- Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH
研究概览
简要总结
The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.
详细描述
Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate
The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.
Other comparisons will be:
Placebo and combination treatment. Solifenacin monotherapy and combination 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •male patients with LUTS associated with BPH diagnosed > 3 months
- •IPSS score > 13
- •voiding and storage symptoms
- •maximum flow rate of > 4 mL/s and < 15 mL/s
排除标准
- •post void residual volume > 200 mL
- •symptomatic urinary tract infection
研究组 & 干预措施
H
干预措施: tamsulosin hydrochloride (Drug)
A
干预措施: Placebo (Drug)
B
干预措施: solifenacin succinate (Drug)
C
干预措施: solifenacin succinate (Drug)
D
干预措施: solifenacin succinate (Drug)
E
干预措施: tamsulosin hydrochloride (Drug)
F
干预措施: tamsulosin hydrochloride (Drug)
F
干预措施: solifenacin succinate (Drug)
G
干预措施: tamsulosin hydrochloride (Drug)
G
干预措施: solifenacin succinate (Drug)
H
干预措施: solifenacin succinate (Drug)
结局指标
主要结局
Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH
时间窗: 12 weeks
次要结局
- Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride(12 weeks)