NCT01380730已完成2 期
LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 631
- 试验地点
- 101
- 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
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 to ≤ 80 years of age
- •On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
- •Fasting LDL-C ≥ 85 mg/dL
- •Fasting triglycerides ≤ 400 mg/dL
排除标准
- •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 (Glycosyated Hemoglobin (HbA1c) > 8.5%)
- •Uncontrolled hypertension
- •New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
- •Uncontrolled cardiac arrhythmia
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
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12(Baseline and Week 12)
- Change From Baseline in LDL-C at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Apolipoprotein B at Week 12(Baseline and Week 12)
研究者
研究点 (101)
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