A Phase 4, Randomized, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2
研究概览
简要总结
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV 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
- •Subject has a serum sodium value between 115 and 133 mEq/L
- •Subject is euvolemic or hypervolemic
排除标准
- •Clinical evidence of volume depletion or dehydration
- •Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment
研究组 & 干预措施
Dose Regimen 2
Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
干预措施: Conivaptan (Drug)
Dose Regimen 1
Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
干预措施: Conivaptan (Drug)
Dose Regimen 1
Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
干预措施: placebo (Drug)
Dose Regimen 3
Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
干预措施: Conivaptan (Drug)
Dose Regimen 3
Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
干预措施: placebo (Drug)
Dose Regimen 4
Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag
干预措施: Conivaptan (Drug)
结局指标
主要结局
Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2
时间窗: 48 hours
Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion. One ISRMS has been reported for each participant \& represents the most severe state of ISR for that participant. ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis
次要结局
- Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period(Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment)
- Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours(24.5 hours, 48.5 hours and 96.5 hours)
- Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period(48.5 hours)
- Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours(0-24.5 hours, 0-48.5 hours and 0-96.5 hours)
- Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours(0-24.5 hours, 0-48.5 hours and 0-96.5 hours)