NCT00563654终止不适用
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo on the Successful Rate of Trial Without Catheter in Patients With Acute Urinary Retention With Long Term Follow up
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Successful rate of Trial Without Catheter (TWOC) at phase 1
研究概览
简要总结
The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Aged 50 or above
- •Admitted for AUR due to BPH with PVR of 500 ml or more
排除标准
- •Previous history of TURP
- •Use of alpha blockers within recent 8 months
- •Renal impairment (serum creatinine >140 umol/l)
- •Poor premorbid state
结局指标
主要结局
Successful rate of Trial Without Catheter (TWOC) at phase 1
时间窗: At discharge after TWOC (at the end phase one)
Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1
时间窗: From the end of phase one to eight months after successful TWOC (the end of phase 2)
次要结局
- Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC(From the time of treatment drug administration to the end of phase 1)
- Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR)(At the end of phase I (discharge after TWOC) and at the end of phase 2)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Alfuzosin for Treating Acute Urinary RetentionAcute Urinary RetentionNCT00336921Sanofi156
已完成
3 期
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder DysfunctionNeurogenic Urinary BladderNCT00549939Sanofi172
已完成
4 期
Once Daily Given Alfuzosin in the Treatment of BPHBenign Prostatic HyperplasiaNCT00637715Sanofi60
终止
3 期
Alfuzosin Versus Placebo in Acute Urinary RetentionUrinary RetentionNCT00453908Sanofi160
已完成
3 期
A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 DiabetesType 2 Diabetes MellitusNCT04591626Eli Lilly and Company291