NCT00347061已完成3 期
A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled 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
- 148
- 试验地点
- 1
- 主要终点
- One year safety data of SL77.0499-10
研究概览
简要总结
Primary:
To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
Secondary:
- To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
- To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography
- •Suffering for at least 6 months from lower urinary tract symptoms related to BPH
- •An I-PSS total score ≥ 13
- •Out patient
排除标准
- •Patients previously treated with SL77.0499-
- •Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.
- •Isolated bladder neck disease.
- •Diagnosed carcinoma of the prostate.
- •Previous prostatic surgery or other invasive procedures (thermotherapy...) for the treatment of BPH.
- •Patients having an indwelling catheter.
- •A residual urine > 200mL.
- •Patients with Moderate or sever hepatic insufficiency.
- •Known hypersensitivity to alpha1-blockers.
- •Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
- •Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.
结局指标
主要结局
One year safety data of SL77.0499-10
次要结局
- One year efficacy data and plasma concentration of SL77.0499-10
研究者
研究点 (1)
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