A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
研究概览
简要总结
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
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
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is determined to be hypertensive
排除标准
- •Participant has a history of severe or symptomatic hypertension
- •Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease
- •Participant has started taking hypertensive medications within the past 30 days
- •Participant has a known sensitivity to losartan or history of angioneurotic edema
研究组 & 干预措施
Losartan potassium 0.1 to 1.4 mg/kg
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
干预措施: losartan potassium (Drug)
Losartan potassium 0.3 to 1.4 mg/kg
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
干预措施: losartan potassium (Drug)
Losartan potassium 0.7 to 1.4 mg/kg
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
干预措施: losartan potassium (Drug)
结局指标
主要结局
Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
时间窗: up to 12 weeks (Base Study); up to 24 months (Extension)
Mean Change From Baseline in Systolic Blood Pressure
时间窗: Baseline and Day 21
Sitting blood pressure (\[BP\] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
时间窗: up to 12 weeks (Base Study); up to 24 months (Extension)
次要结局
- Mean Change From Baseline in Diastolic Blood Pressure(Baseline and Day 21)