A Randomized, Placebo- and Ezetimibe-controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 411
- 试验地点
- 1
- 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 was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy 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 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
- •Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
- •Framingham risk score of 10% or less
- •Fasting triglycerides < 400 mg/dL
排除标准
- •History of coronary heart disease
- •New York Heart Association (NYHA) II - IV heart failure
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled hypertension
研究组 & 干预措施
Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
干预措施: Placebo to Evolocumab (Other)
Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
干预措施: Placebo to Evolocumab (Other)
Ezetimibe
Participants received 10 mg ezetimibe orally once a day for 12 weeks.
干预措施: Ezetimibe (Drug)
Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
干预措施: Evolocumab (Biological)
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
- 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 (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/Apolipoprotein A-1 Ratio at Week 12(Baseline and Week 12)