A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 316
- 试验地点
- 76
- 主要终点
- Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
研究概览
简要总结
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
Primary Objective of the study:
- To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia
Secondary Objectives:
- To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
- To evaluate the effect of alirocumab on other lipid parameters
- To evaluate the safety and tolerability of alirocumab
详细描述
The maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo Q2W
Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
干预措施: Placebo (for alirocumab) (Drug)
Placebo Q2W
Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
干预措施: Lipid-Modifying Therapy (LMT) (Drug)
Alirocumab
Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
干预措施: Alirocumab (Drug)
Alirocumab
Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
干预措施: Lipid-Modifying Therapy (LMT) (Drug)
结局指标
主要结局
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
时间窗: From Baseline to Week 52
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
次要结局
- Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis(From baseline to Week 52)
- Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Apo B at Week 12 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Total-C at Week 12 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis(From Baseline to Week 52)
- Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis(Up to Week 52)
- Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis(Up to Week 52)
- Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis(From baseline to Week 52)
- Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis(From Baseline to Week 52)