NCT01763918已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 331
- 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 evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (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 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
- •Diagnosis of heterozygous familial hypercholesterolemia
- •On a stable dose of an approved statin and lipid regulating medication
- •Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)
- •Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
排除标准
- •Homozygous familial hypercholesterolemia
- •LDL or plasma apheresis
- •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
Placebo Q2W
Placebo Comparator
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
干预措施: Placebo (Drug)
Placebo QM
Placebo Comparator
Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
干预措施: Placebo (Drug)
Evolocumab Q2W
Experimental
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
干预措施: Evolocumab (Biological)
Evolocumab QM
Experimental
Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
干预措施: Evolocumab (Biological)
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 Week 12(Baseline and Week 12)
- Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) 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 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 Triglycerides at Week 12(Baseline and Week 12)
- Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in HDL-C at Week 12(Baseline and Week 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)
- Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12(Week 12)
- Change From Baseline in LDL-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)
- 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 Apolipoprotein B at Week 12(Baseline and Week 12)
- Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 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 A1 Ratio 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 Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
- Percent Change From Baseline in VLDL-C at Week 12(Baseline and Week 12)
研究者
研究点 (1)
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