NCT00280605已完成4 期
Study of the Outcome of Patients With Lower Urinary Symptoms Suggestive of Benign Prostatic Hyperplasia and Treated With Alfuzosin 10 mg Once Daily for 3 Months in China
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
- 200
- 主要终点
- Spontaneous adverse events
研究概览
简要总结
The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia
排除标准
- •Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months
- •Patients previously not improved by an alpha 1-blocker treatment
- •Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI)
- •Known hypersensitivity to alfuzosin
- •History of postural hypotension or syncope
- •Combination with other alpha 1-blockers
- •Hepatic insufficiency
- •Unstable angina pectoris
- •Severe concomitant condition threatening life
结局指标
主要结局
Spontaneous adverse events
Blood pressure and heart rate measured in sitting position
International Prostate Symptom Score (IPSS) and quality of life index
DAN-PSS sexual function score
PSA levels measured at baseline
Maximum flow rate and residual urine
次要结局
未报告次要终点
研究者
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