NCT02827578Unknown3 期
Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia : a Randomized, Double Blinded, Parallel Design, Active Controlled, Multi-center, Phase 3 Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 588
- 试验地点
- 1
- 主要终点
- The change of total IPSS(International prostate symptom score)
研究概览
简要总结
Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
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
- •Healthy male aged 45 years old or older
- •Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination
- •Subjects with lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form
排除标准
- •Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years
- •Subjects who have acute urinary retention within 4 weeks before screening
- •Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening
- •Subjects who have hypersensitivity to investigational product or sulfa medications
- •Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,)
- •Subjects who have myasthenia gravis, narrow angle glaucoma or autonomic neuropathy
- •Subjects who have cataract or glaucoma scheduled to be operated in the study duration.
- •Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.
研究组 & 干预措施
Tamsulosin + Solifenacin
Experimental
Tamsulosin and Solifenacin
干预措施: Tamsulosin (Drug)
Tamsulosin + Solifenacin
Experimental
Tamsulosin and Solifenacin
干预措施: Solifenacin (Drug)
Tamsulosin + Solifenacin Placebo
Active Comparator
Tamsulosin and Solifenacin placebo
干预措施: Tamsulosin (Drug)
Tamsulosin + Solifenacin Placebo
Active Comparator
Tamsulosin and Solifenacin placebo
干预措施: Solifenacin placebo (Drug)
结局指标
主要结局
The change of total IPSS(International prostate symptom score)
时间窗: From baseline at week 12
The change of TUFS((Total Urgency and Frequency Score)/24h
时间窗: From baseline at week 12
次要结局
- The change of IPSS(International prostate symptom score) QoL(Quality of Life)(From baseline at week 4, 8 and 12)
- The change of voiding frequency/24h(From baseline at week 4, 8 and 12)
- The change of nocturnal frequency/24h(From baseline at week 4, 8 and 12)
- The change of IPSS(International prostate symptom score)-sub score(From baseline at week 4, 8 and 12)
- The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4(From baseline at week 12)
- The change of urgency/24h(From baseline at week 4, 8 and 12)
- The change of urge urinary incontinence frequency/24h(From baseline at week 4, 8 and 12)
- The change of PPBC(Patient perception of bladder condition)(From baseline at week 4 and 12)
- PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change)(From baseline at week 12)
研究者
研究点 (1)
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