NCT00358878已完成3 期
Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 463
- 试验地点
- 1
- 主要终点
- Composite endpoint of ascites worsening
研究概览
简要总结
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.
Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.
The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).
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
- •Participants with cirrhosis of the liver
- •Participants with clinically evident ascites primarily managed by diet and/or diuretics
- •Stable treatment of ascites for at least the previous 2 weeks without paracentesis
- •Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.
排除标准
- •Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt
- •Known hepatocellular carcinoma
- •Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
- •Participants previously exposed to satavaptan in the past 12 months
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Satavaptan
Experimental
干预措施: Satavaptan (Drug)
结局指标
主要结局
Composite endpoint of ascites worsening
时间窗: at week 12
次要结局
- Composite endpoint of ascites worsening(at week 24)
- Increase in ascites(at week 12)
研究者
研究点 (1)
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