NCT00366795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 in the Absence of 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
- 241
- 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 in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.
Secondary:
To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients 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
- •Patients with cirrhosis of the liver.
- •Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
- •Patients 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 = or > 4 litres of fluid.
- •at least one other therapeutic paracentesis in the previous 3 months.
排除标准
- •Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
- •Known hepatocellular carcinoma.
- •Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
- •Patients 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
- Increase in ascites(over 12 weeks)
- Time from randomisation to first recurrence of ascites(study period)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the LiverAscitesLiver CirrhosisNCT00359437Sanofi501
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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-1Cirrhotic ascitesMedDRA version: 8.1Level: LLTClassification code 10003445EUCTR2006-000134-12-DESanofi-Aventis Recherche & Devéloppement450
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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-1Cirrhotic ascitesMedDRA version: 8.1Level: LLTClassification code 10003445EUCTR2006-000134-12-BESanofi- aventis R&D450
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 in the absence of diuretics in patients with recurrent ascites due to cirrhosis of the liver - SPARe-2Cirrhotic ascitesMedDRA version: 8.1Level: LLTClassification code 10003445EUCTR2006-000135-10-BESanofi-aventis R&D225
进行中（未招募）
不适用
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