NCT00501384已完成2 期
Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 151
- 试验地点
- 11
- 主要终点
- Time to repeat therapeutic paracentesis
研究概览
简要总结
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.
The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.
This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
- •Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
- •Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
Time to repeat therapeutic paracentesis
时间窗: 12 weeks
次要结局
- Increase in ascites judged by body weight and ascites volume(within 12 weeks)
- frequency of paracentesis(12 weeks)
- quality of life(12 weeks)
研究者
研究点 (11)
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