A Multicenter, Open-labeled, Dose-defining Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline
研究概览
简要总结
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with volume overload despite having received any of the following diuretic therapies in whom sufficient effects cannot be expected even if the dose of the diuretics is increased or in whom the investigator or subinvestigator judges that increasing the dose of the diuretics is difficult due to concerns regarding electrolyte abnormalities or other side effects
- •Furosemide (oral administration) ≥0.5 mg/kg/day. Azosemide 30 mg and torasemide 4 mg will be calculated as equivalent to furosemide 20 mg.
- •Hydrochlorothiazide ≥2 mg/kg/day
- •Trichlormethiazide ≥0.05 mg/kg/day
- •Spironolactone ≥ 1 mg/kg/day
- •Patients capable of complaining of thirst. Patients unable to complain of thirst due to their young age can also be enrolled in the trial if strict management of fluid intake and excretion is conducted. However, even if such fluid management is possible, the patients in whom the investigator or subinvestigator judges that tolvaptan cannot be safely administered are to be excluded
- •Patients who can be hospitalized from at least 3 days before start of tolvaptan administration until 2 days after the final administration.
排除标准
- •Patients whose volume overload status shows improvement during the screening period or pretreatment observation period
- •Patients who are unable to drink fluid (including patients who are unable to sense thirst)
- •Patients whose circulatory blood flow is suspected to be decreased
- •Patients with an assisted circulation apparatus
- •Patients with hypernatremia (serum or blood sodium concentration exceeding 145 mEq/L) others
研究组 & 干预措施
Tolvaptan
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
干预措施: Tolvaptan (Drug)
结局指标
主要结局
Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline
时间窗: Day after Day 3 at evaluation dose
The primary endpoint of this trial was the percentage of subjects whose body weight on the day after the third day of treatment with tolvaptan at the evaluation dose (the third day of administration at the evaluation dose) was decreased by 1.7% or more from the weight measured before breakfast (baseline) on the first day of the treatment period (the initial tolvaptan administration day), under the condition that the mean daily urine volume for the 3 days of treatment with tolvaptan at the evaluation dose was higher than the daily urine volume for the pretreatment observation period. The percentage of subjects as well as the exact 95% confidence interval (CI) based on binomial distribution were calculated.
次要结局
- Improvement Rates of Pulmonary Congestion(Day after Day 3 at evaluation dose)
- Improvement Rates of Lower Limb Edema(Day after Day 3 at evaluation dose)
- Change Rate From Baseline in Daily Urine Volume(Baseline, Day1, Day2 and Day3 of administration at evaluation dose)
- Percent Changes From Baseline in Body Weight (kg)(Day after Day 3 at evaluation dose)