NCT00029822已完成3 期
Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,522
- 试验地点
- 90
- 主要终点
- occurrence of first episode of acute urinary retention (AUR)
研究概览
简要总结
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH.
- Free study-related medical care provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Has been suffering for at least 6 months with any of the following symptoms:
- •daytime or nighttime urinary frequency
- •urgent feeling to urinate
- •difficulty starting urinary stream
- •interruption of urinary stream
- •feeling of incomplete urination
- •Has not had a previous episode of acute urinary retention
- •Has not been diagnosed with prostate cancer
- •Has not had previous prostate surgery
- •Is not an insulin-dependent diabetic
排除标准
- 未提供
结局指标
主要结局
occurrence of first episode of acute urinary retention (AUR)
次要结局
- need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
研究者
研究点 (90)
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