A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 307
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in 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 (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).
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
- •Not on a statin or on a low dose statin with stable dose for at least 4 weeks
- •History of intolerance to at least 2 statins
- •Subject not at LDL-C goal
- •Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
- •Fasting triglycerides ≤ 400 mg/dL
排除标准
- •New York Heart Association (NYHA) III or IV heart failure
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled hypertension
- •Type 1 diabetes, poorly controlled type 2 diabetes
- •Uncontrolled hypothyroidism or hyperthyroidism
研究组 & 干预措施
Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
干预措施: Placebo to Evolocumab (Drug)
Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
干预措施: Ezetimibe (Drug)
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
干预措施: Placebo to Evolocumab (Drug)
Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
干预措施: Ezetimibe (Drug)
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
干预措施: Placebo to Ezetimibe (Drug)
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
干预措施: Placebo to Ezetimibe (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-C at Week 12
时间窗: Baseline and Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
时间窗: Baseline and Weeks 10 and 12
次要结局
- Change From Baseline in LDL-C at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)(Weeks 10 and 12)
- Percent Change From Baseline in Apolipoprotein B at Week 12(Baseline and Week 12)
- Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12(Baseline and Week 12)
- Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) 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-HDL-C at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in Non-HDL-C at Week 12(Baseline and Week 12)
- Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12(Week 12)
- Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in Lipoprotein (a) at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12(Baseline and Week 12)
- Percent Change From Baseline in Triglycerides at Week 12(Baseline and Week 12)