NCT01375751已完成2 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Subject With Heterozygous Familial Hypercholesterolemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 168
- 主要终点
- Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
研究概览
简要总结
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial hypercholesterolemia (HeFH).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 to ≤ 75 years of age
- •Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991)
- •On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
- •Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
- •Fasting triglycerides ≤ 400 mg/dL
排除标准
- •Homozygous familial hypercholesterolemia
- •Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization
- •New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
- •Uncontrolled cardiac arrhythmia
- •Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
- •Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c > 8.5%)
- •Uncontrolled hypertension
结局指标
主要结局
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
次要结局
- Absolute Change From Baseline in LDL-C at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Apolipoprotein B at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline and Week 12)
- Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Apolipoprotein B /Apolipoprotein A-1 Ratio at Week 12(Baseline and Week 12)
研究者
相似试验
已完成
3 期
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed DyslipidemiaDiabetes, Hyperlipidemia, Mixed DyslipidemiaNCT02662569Amgen986
已完成
3 期
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4HypercholesterolemiaNCT02634580Amgen61
已完成
3 期
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular RiskHyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular EventsNCT01953328Amgen409
已完成
2 期
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese SubjectsHypercholesterolemia and High Risk for Cardiovascular EventsNCT01652703Amgen310
已完成
3 期
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2HyperlipidemiaNCT01763918Amgen331