NCT02972268已完成3 期
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
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
- 780
- 试验地点
- 1
- 主要终点
- change of TUFS
研究概览
简要总结
Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Over 45 years
- •Benign Prostate Hyperplasia diagnosed by 20 mL < TRUS
- •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 3 years
- •Subjects who have acute urinary retention within 12 weeks before screening
- •Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
- •Subjects who have hypersensitivity to investigational product
- •Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
- •Subjects who have myasthenia gravis, narrow angle glaucoma
- •Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •SBP > 180 mmHg or DBP > 100 mmHg
- •HbA1c > 9.0 %
- •Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.
研究组 & 干预措施
Group II
Placebo Comparator
Tamsulosin 0.2mg + Placebo(Solifenacin)
干预措施: Tamsulosin 0.2mg + Placebo(Solifenacin) (Drug)
Group I
Experimental
Tamsulosin 0.2mg + Solifenacin 5mg
干预措施: Tamsulosin 0.2mg + Solifenacin 5mg (Drug)
结局指标
主要结局
change of TUFS
时间窗: 12 weeks from baseline
change of total IPSS
时间窗: 12 weeks from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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