NCT00575913已完成4 期
ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study
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
- 118
- 试验地点
- 1
- 主要终点
- improvements in urinary symptoms and quality of life index
研究概览
简要总结
To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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 BPH.
排除标准
- •Patients requiring BPH surgery immediately or within the 12 following months:
- •Acute renal obstruction
- •Chronic renal obstruction
- •Chronic renal failure from BPH
- •Bladder stone
- •Recurrent urinary tract infection
- •Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
- •Hematuria from BPH
- •Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
- •Patients previously not improved by an alpha1-blocker treatment
- •Known hypersensitivity to alfuzosin
- •History of postural hypotension or syncope
- •Combination with other alpha1-blockers
- •Hepatic enzyme (SGOT or/and SGPT ) > 1.5 Upper Normal Limit
- •Unstable angina pectoris
- •Severe concomitant condition threatening life.
- •Patients who had failed treatment with finasteride (Proscar)
- •Patients with neuropathic bladder.
- •Patients with history of previous surgery for BPH
- •Patients with high risk for prostate cancer based on the clinical judgement of the investigator
- •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
improvements in urinary symptoms and quality of life index
时间窗: During all the study conduct
次要结局
- Improvement in sexual function(During all the study conduct)
- Improvement in maximum flow rate (determined by uroflowmetry)(During all the study conduct)
- Collection of spontaneously reported adverse events(At each visit)
研究者
研究点 (1)
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