Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,228
- 试验地点
- 1
- 主要终点
- Change in baseline total score on the International Prostate Symptom Score
研究概览
简要总结
A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.
详细描述
This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia
排除标准
- •Medical conditions that would confound the efficacy evaluation
- •Medical conditions in which it would be unsafe to use an alpha-blocker
- •Use of concomitant drugs that would confound the efficacy evaluation
- •Use of concomitant drugs that would be unsafe with this alpha-blocker
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Silodosin
干预措施: Silodosin (Drug)
Tamsulosin
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Change in baseline total score on the International Prostate Symptom Score
时间窗: 12 weeks
次要结局
- Change in baseline obstructive subscore of the International Prostate Symptom Score;(12 weeks)
- change in baseline irritative subscore of the International Prostate Symptom Score;(12 weeks)
- change in baseline maximum urine flow rate;(12 weeks)
- safety(52 weeks)