A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 461
- 主要终点
- International Prostate Symptom Score (IPSS)
研究概览
简要总结
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
详细描述
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.
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.
- •The use of concomitant drugs that would confound the efficacy evaluation.
- •The use of concomitant drugs that would be unsafe with this alpha-blocker.
研究组 & 干预措施
Silodosin
Silodosin 8 mg once daily with food
干预措施: Silodosin (Drug)
placebo
Matching Placebo capsule once daily with food
干预措施: Placebo (Other)
结局指标
主要结局
International Prostate Symptom Score (IPSS)
时间窗: 12 weeks
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
次要结局
- Maximum Urine Flow Rate (Qmax)(12 weeks)