NCT00379847已完成3 期
A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia
Cumberland Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2004年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Baseline-adjusted change in AUC for serum sodium
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
- None
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 less than or equal 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
研究组 & 干预措施
1
Experimental
Lower dose
干预措施: conivaptan (Drug)
2
Experimental
Higher dose
干预措施: conivaptan (Drug)
结局指标
主要结局
Baseline-adjusted change in AUC for serum sodium
时间窗: 96 Hours
次要结局
- Comparison of safety between patients in each study arm(96 Hours)
研究者
研究点 (2)
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