NCT00501722已完成2 期
SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: 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
- 110
- 试验地点
- 13
- 主要终点
- change in body weight, change in serum sodium
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 and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.
The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.
This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). 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
- •Moderate or tense ascites
- •Patients with hyponatremia, defined as a serum sodium concentration 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, change in serum sodium
时间窗: within 14 days
次要结局
- abdominal girth and discomfort(14 days)
- paracentesis(14 days)
- trail-making test and quality of life(14 days)
研究者
研究点 (13)
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