NCT00359437终止3 期
Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent 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
- 终止
- 发起方
- Sanofi
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Number and time of recurrences of therapeutic paracenteses
研究概览
简要总结
Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.
Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent 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 recurrent ascites having undergone both of the following:
- •therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of > 4 litres of fluid.
- •at least one other therapeutic paracentesis in the previous 3 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
Satavaptan
Experimental
干预措施: Satavaptan (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number and time of recurrences of therapeutic paracenteses
时间窗: up to 12 weeks
次要结局
- Time from randomisation to first recurrence of ascites(study period)
- Increase in ascites(over 12 weeks)
研究者
研究点 (1)
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相似试验
终止
3 期
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进行中（未招募）
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Satavaptan in the Prevention of Ascites Recurrence: a double-blind, randomised, parallel-group comparison of satavaptan at 5 to 10 mg daily versus placebo with concomitant diuretics in patients with recurrent ascites due to cirrhosis of the liver - SPARe-1EUCTR2006-000134-12-HUSanofi-Synthelabo Recherche450