NCT01801228撤回2 期
Swedish, Multicentered, Randomized Study of Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis Regarding Efficacy and Side Effects
Emma Nilsson1 个研究点 分布在 1 个国家开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Ascites
研究概览
简要总结
This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Ascites Cirrhosis
排除标准
- •Prior treatment with aldosterone antagonist Uncontrolled heart disease or diabetes Current malignancy Current medication interacting with aldosterone antagonists
研究组 & 干预措施
Eplerenone
Experimental
oral daily treatment with doses 100 to 400 mg
干预措施: Eplerenone (Drug)
Spironolactone
Active Comparator
oral daily treatment with doses 100 to 400 mg
干预措施: Eplerenone (Drug)
结局指标
主要结局
Ascites
时间窗: 6 months
次要结局
未报告次要终点
研究者
Emma Nilsson
Gastroenterologist
Region Skane
研究点 (1)
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