Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2,341
- 试验地点
- 320
- 主要终点
- Percentage of Participants Who Experienced Adverse Events (AEs)
研究概览
简要总结
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).
Secondary Objectives:
- To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
- To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
- To evaluate the effects of alirocumab on other lipid parameters.
详细描述
The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-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
Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.
干预措施: Placebo (for alirocumab) (Drug)
Placebo
Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.
干预措施: Lipid-Modifying Therapy (LMT) (Drug)
Alirocumab
Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.
干预措施: Alirocumab (Drug)
Alirocumab
Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.
干预措施: Lipid-Modifying Therapy (LMT) (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Adverse Events (AEs)
时间窗: Up to 10 weeks after last study drug administration (maximum of 86 weeks)
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).
次要结局
- Percent Change From Baseline in Measured LDL-C 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 Fasting Triglycerides at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) 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 24 - 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 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)
- Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis(Up to Week 52)
- Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis(Up 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 Calculated LDL-C at Week 12 - 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 Lipoprotein (a) 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)
- 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 HDL-C at Week 24 - ITT Analysis(From Baseline to Week 52)
- Percent Change From Baseline in Apo A1 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)