NCT00355615已完成3 期
A Phase IIIb, Efficacy, and Safety Study of Rosuvastatin in Children 10-17 Years of Age With Heterozygous Familial Hypercholesterolemia: a 12-week, Double-blind, Randomized, Multicenter, Placebo-controlled Study With a 40-week, Open-label, Follow-up
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
- AstraZeneca
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase
研究概览
简要总结
The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (at least 1 year post-menarche) children and adolescents (aged 10 -17 years) with heterozygous familial hypercholesterolemia (HeFH)
排除标准
- •Certain medical conditions and lab test results
- •History of a reaction to rosuvastatin or other statin drugs
- •Use of specified disallowed medications
研究组 & 干预措施
rosuva 5
Active Comparator
rosuvastatin 5 mg
干预措施: Rosuvastatin (Drug)
rosuva 10
Active Comparator
rosuvastatin 10 mg
干预措施: Rosuvastatin (Drug)
rosuva 20
Active Comparator
rosuvastatin 20 mg
干预措施: Rosuvastatin (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
rosuva ol
Other
rosuvastatin open label
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase
时间窗: 12 weeks
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100
次要结局
- Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12)(6 weeks)
- Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment(12 weeks)
- Percent Change in HDL-C(After 12 weeks of treatment)
- Percent Change in Non-HDL-C at 12 Weeks(After 12 weeks of treatment)
- Percent Change in Triglycerides (TG)(After 12 weeks of treatment)
- Percent Change in Total Cholesterol (TC)(After 12 weeks of treatment)
- Percent Change in Apolipoprotein A-1 (ApoA-1)(After 12 weeks of treatment)
- Percent Change in Apolipoprotein B (ApoB)(After 12 weeks of treatment)
- Percent Change in ApoB/ApoA-1(After 12 weeks of treatment)
- Percent Change in LDL-C/HDL-C(After 12 week of treatment)
- Percent Change in TC/HDL-C(After 12 weeks of treatment)
- Percent Change in Non-HDL-C/HDL-C(After 12 weeks of treatment)
研究者
研究点 (2)
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