NCT00867165已完成3 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) (Phase 3, Protocol No. P05522)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
研究概览
简要总结
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.
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
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each subject may be of either sex and of any race/ethnicity, and must be >=6 and <=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of >159mg/dL
- •Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.
排除标准
- •Each subject must not:
- •Have known hypersensitivity or any contraindication to ezetimibe.
- •Have use of any investigational drugs within 30 days of study entry.
- •Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
- •Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
- •Have known congenital cardiac disorder.
- •Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH).
- •Be known to be human immunodeficiency virus (HIV) positive.
研究组 & 干预措施
Ezetimibe
Experimental
Ezetimibe 10-mg tablet once daily for 12 weeks
干预措施: ezetimibe (Drug)
Placebo
Placebo Comparator
Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline and Week 12
Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol \[HDL-C\] + triglyceride \[TG\]/5).
次要结局
- Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12(Baseline and Week 12)
- Percent Change From Baseline in LDL-C at Week 8(Baseline and Week 8)
- Percentage Change From Baseline HDL-C at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12(Baseline and Week 12)
- Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in TC at Week 4(Baseline and Week 4)
- Percentage Change From Baseline HDL-C at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in Non-HDL-C at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Non-HDL-C at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in Triglycerides (TG) at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in TC at Week 2(Baseline and Week 2)
- Percentage Change From Baseline HDL-C at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in Non-HDL-C at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in TG at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in TG at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in Total Cholesterol (TC) at Week 12(Baseline and Week 12)
- Percent Change From Baseline in LDL-C at Week 2(Baseline and Week 2)
- Percent Change From Baseline in LDL-C at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in TC at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Non-HDL-C at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in TG at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in TC:HDL-C Ratio at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in TC:HDL-C Ratio at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in TC:HDL-C Ratio at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in TC:HDL-C Ratio at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in Lathosterol at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in Lathosterol at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Cholestanol at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Sitosterol at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in Sitosterol at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Campesterol at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in Campesterol at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Campesterol at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in Cholestanol at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in Sitosterol at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in Sitosterol at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in Cholestanol at Week 2(Baseline and Week 2)
- Percentage Change From Baseline in Cholestanol at Week 8(Baseline and Week 8)
- Percentage Change From Baseline in Lathosterol at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in Campesterol at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in Lathosterol at Week 2(Baseline and Week 2)
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