NCT00637715已完成4 期
Evaluation of the Effect of 10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH)
研究概览
简要总结
Collection of the data on the safety and efficacy of the once daily administration of the alfuzosin preparation /Alfetim Uno® l0 mg/ at patients with lower urinary tract symptoms/complaints rendering possible the presence of benign prostatic hyperplasia, in the course of everyday practice
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sexually active male patient with lower urinary tract symptoms indicative of severe BPH, at whom disturbances of urinary retention and urination are present
排除标准
- •Necessity of surgical intervention immediately or within 12 months because of BPH
- •The patient has earlier /within 6 months/ obtained treatment because of BPH
- •The patient did not improve on earlier alpha-1 blocker treatment
- •Known hypersensitivity to alfuzosin
- •Orthostatic hypotension in the history
- •Concomitant application with another alpha-1 blocker
- •Hepatic insufficiency /AST, ALT 3 fold of the upper limit of the normal value/
- •Severe renal insufficiency /se creatinine greater than or equal to 150 umol/l/
- •Intestinal obstruction /because of the castor oil content of the drug/
- •Tumorous disease
- •Severe, life threatening state
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
To collect additional clinical data on the safety profile and efficacy of alfuzosin 10 mg o. d. in patients with low-urinary tract symptoms caused by benign prostatic hyperplasia (BPH)
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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