NCT00552097已完成3 期
Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Subjects With Heterozygous Familial Hypercholesterolemia (The ENHANCE Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 主要终点
- Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint.
研究概览
简要总结
The purpose of the study is to determine whether ezetimibe plus simvastatin will be more effective than simvastatin alone in preventing progression of atherosclerosis of the inner layer of the carotid artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Genotype-confirmed heterozygous familial hypercholesterolemia with written documentation of the genetic diagnosis at the time of screening and LDL-C >=210 mg/dL (5.43 mmol/L), or clinical diagnosis of heterozygous familial hypercholesterolemia, defined as LDL-C >=210 mg/dL (5.43 mmol/L) and at least one of the following:
- •tendinous xanthoma
- •child <18 years of age with hypercholesterolemia (LDL-C >159 mg/dL (4.11 mmol/L)
- •has a sibling with hypercholesterolemia (LDL-C >190 mg/dL [4.91 mmol/L]) and tendinous xanthoma
- •family history with an LDL-C value distribution pattern compatible with dominant autosomal transmission and at least one relative presenting fasting total cholesterol values >348 mg/dL (9.0 mmol/L) after exclusion of secondary causes of dyslipidemia
- •LDL-C >=210 mg/dL (5.43 mmol/L) 1 week before randomization
- •plasma triglyceride level <=400 mg/dL (4.52 mmol/L)
排除标准
- •pregnancy or any other situation, condition, or illness that, in the opinion of the investigator, may interfere with optimal participation in the study
- •presence of an apolipoprotein B gene mutation with confirmed absence of an LDL receptor mutation in either allele
- •undergoing LDL-apheresis or plasma apheresis
- •unsuitable plaque or artery morphology
- •use of certain drugs, foods, or other agents known to alter cholesterol levels or to cause pharmacokinetic interactions with either ezetimibe or simvastatin
研究组 & 干预措施
EZ/Simva
Experimental
干预措施: ezetimibe (plus simvastatin) (Drug)
Placebo/Simva
Placebo Comparator
干预措施: placebo (plus simvastatin) (Drug)
结局指标
主要结局
Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint.
时间窗: 24 months
次要结局
- Change in ultrasound-determined maximum carotid artery IMT on a per subject basis between baseline and endpoint.(24 months)
- Proportion of subjects developing new carotid artery plaques between baseline and endpoint.(24 months)
- Proportion of subjects with a reduction in ultrasound-determined average carotid artery IMT between baseline and endpoint.(24 months)
- Change in ultrasound-determined average carotid artery plus average common femoral artery IMT on a per subject basis between baseline and endpoint.(24 months)
研究者
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