NCT00379067已完成4 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 882
- 主要终点
- The change from baseline to week 12 in mean number of nocturnal voids
研究概览
简要总结
Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg & placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as having LUTS associated with BPH
- •On average, at least 2 voids per night over the last week
- •A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)
排除标准
- •Subject is currently taking diuretics
- •Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
研究组 & 干预措施
1
Active Comparator
Tamsulosin OCAS tablet
干预措施: Tamsulosin OCAS (Drug)
2
Placebo Comparator
Placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
The change from baseline to week 12 in mean number of nocturnal voids
时间窗: 12 weeks
次要结局
- The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void(12 weeks)
研究者
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