NCT00657839已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 222
- 主要终点
- International Prostate Symptom Score and maximal urinary flow
研究概览
简要总结
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 45 to 64 years of age
- •Lower urinary tract symptoms > 6 months
- •International Prostate Symptom Score > 12
排除标准
- •Prostate Specific Antigen > 3 ng/ml
- •Residual urine volume > 150 m
- •History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- •Nitrate use
- •Other exclusion criteria apply acc. to Summary of Product Characteristics
研究组 & 干预措施
Arm 1
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
International Prostate Symptom Score and maximal urinary flow
时间窗: 8 weeks
次要结局
- International Prostate Symptom Score, storing and voiding subscore(8 weeks)
- IIEF-EF domains score(8 weeks)
- Safety and tolerability(8 weeks)
研究者
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