NCT00478192已完成3 期
A Phase IIIb, Randomized, Double-Blind, Parallel Group, Multi-Center, Study to Assess the Efficacy and Safety of Multiple 30 Minute Infusions of YM087 (Conivaptan) in Subjects With Euvolemic or Hypervolemic Hyponatremia
Cumberland Pharmaceuticals0 个研究点目标入组 50 人开始时间: 2007年4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
- 50
- 主要终点
- Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.
研究概览
简要总结
The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects 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 (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
- •Euvolemic or hypervolemic (edematous) based on clinical presentation
- •Serum sodium between 115 and 130mEq/L at baseline
排除标准
- •Clinical presentation of volume depletion or dehydration
研究组 & 干预措施
Regimen 1 Conivaptan QD
Experimental
20 mg conivaptan once a day
干预措施: Conivaptan (Drug)
Regimen 2 Conivaptan BID
Experimental
20 mg conivaptan two times a day
干预措施: Conivaptan (Drug)
Regimen 3 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.
时间窗: Baseline and 48 hours
Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1. Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment. Change is calculated as Hour 48 - Baseline.
次要结局
- Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment(Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48)
- Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium(48 Hours)
- Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours(48 Hours)
- Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours(48 Hours)
- Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours(48 Hours)
- Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment(Baseline, Hour 12, Hour 24,Hour 36 and Hour 48)
- Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment(Baseline, Hour 24 and Hour 48)
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