A 12 Week, Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, Tolerability And Actual Use Of Bococizumab And An Autoinjector (Pre-filled Pen) In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 299
- 试验地点
- 60
- 主要终点
- Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4
研究概览
简要总结
This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).
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
- •Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL
排除标准
- •Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension
研究组 & 干预措施
Bococizumab 150mg
Bococizumab 150mg autoinjector (pre-filled pen)
干预措施: Bococizumab 150mg (Biological)
Bococizumab 75mg
Bococizumab 75mg autoinjector (pre-filled pen)
干预措施: Bococizumab 75mg (Biological)
Bococizumab 150mg placebo
Bococizumab 150mg placebo autoinjector (pre-filled pen)
干预措施: Bococizumab 150mg placebo (Biological)
Bococizumab 75mg placebo
Bococizumab 75mg autoinjector (pre-filled pen)
干预措施: Bococizumab 75mg placebo (Biological)
结局指标
主要结局
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4
时间窗: Week 4
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2
时间窗: Week 2
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8
时间窗: Week 8
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo
时间窗: Baseline, Week 12
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)
时间窗: Week 0 (Day 1)
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10
时间窗: Week 10
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6
时间窗: Week 6
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
次要结局
- Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12(Baseline, Week 12)
- Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10(Week 0 (Day 1), 2, 4, 6, 8, 10)
- Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12(Baseline, Week 12)
- Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo(Baseline, Week 12)
- Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)(Baseline up to 18 weeks)
- Plasma Concentration of Bococizumab at Week 12(Week 12)
- Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12(Week 12)
- Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8(Week 0 (Day 1), 4, 8)
- Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12(Baseline, Week 12)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 18 weeks)