NCT00501566已完成2 期
SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
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
- 148
- 试验地点
- 12
- 主要终点
- Change in body weight
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 treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.
The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.
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
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
- •Moderate or tense ascites
- •Serum sodium of >130 mmol/l.
- •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
Change in body weight
时间窗: within 14 days
次要结局
- Paracentesis(14 days)
- Quality of life(14 days)
- Abdominal girth and discomfort(14 days)
研究者
研究点 (12)
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