NCT00380575已完成3 期
A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
Cumberland Pharmaceuticals47 个研究点 分布在 4 个国家目标入组 84 人开始时间: 2000年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 47
- 主要终点
- The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).
研究概览
简要总结
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
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
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
- •Serum sodium levels 115 to < 130mEq/L
- •Euvolemic or Hypervolemic hyponatremia
排除标准
- •Clinical evidence of volume depletion or dehydration
- •Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
- •Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
结局指标
主要结局
The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).
次要结局
未报告次要终点
研究者
研究点 (47)
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