NCT00399464已完成3 期
Efficacy and Safety of SL77.0499-10 10mg Once Daily in Comparison With Placebo and Tamsulosin Hydrochloride 0.2mg in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).
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
- 1,177
- 试验地点
- 1
- 主要终点
- Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)
研究概览
简要总结
The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH.
The secondary objective is to assess the safety of SL77.0499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Japanese;
- •Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months;
- •Suffering for at least 6 months from lower urinary tract symptoms related to BPH.
排除标准
- •Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment;
- •Inpatient;
- •Patients having participated in a clinical trial within the previous 6-month;
- •Patients previously treated with SL77.0499-10;
- •Patients whose I-PSS total score do not meet ≥ 13;
- •Patients whose urinary peak flow rate (PFR) do not meet 5.0-12.0mL/s for a voided volume of at least 150mL;
- •Patients whose residual urine are > 200mL;
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
结局指标
主要结局
Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)
次要结局
- Efficacy: Change in I-PSS total score from baseline to each visit
- Change in Quality Of Life score from baseline to each visit
- Change from baseline to endpoint of residual urine volume and urinary Peak Flow
- Safety:Adverse events
研究者
研究点 (1)
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