NCT01975389终止3 期
Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 10,564
- 试验地点
- 1,554
- 主要终点
- Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event
研究概览
简要总结
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).
详细描述
The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Must be on background lipid lowering treatment.
- •Must be at high risk of a CV event.
- •Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).
排除标准
- •Planned coronary (PCI or CABG) or other arterial revascularization.
- •New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
- •Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.
- •History of hemorrhagic stroke.
- •Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
研究组 & 干预措施
bococizumab (PF-04950615)
Experimental
150 mg, every 2 weeks, subcutaneous.
干预措施: bococizumab (PF-04950615) (Drug)
Placebo
Placebo Comparator
Placebo comparator, every 2 weeks, subcutaneous.
干预措施: Placebo (Drug)
结局指标
主要结局
Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event
时间窗: From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)
Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death \[defined as sudden cardiac death, fatal myocardial infarction (MI), death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes\] non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 participant-years at risk.
次要结局
- Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke(From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infraction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization(From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke(From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization(From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina(From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for Cardiovascular (CV) Death(From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Any Myocardial Infarction (Fatal or Non-fatal)(From baseline until the date of first adjudicated and confirmed occurrence of any myocardial infarction (fatal or non-fatal) (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for Fatal Myocardial Infarction (MI)(From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Myocardial Infarction (MI)(From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal)(From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal), of Any Etiology(From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for Fatal Stroke(From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Stroke(From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina(From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)(From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Coronary Revascularization(From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)(From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Percutaneous Coronary Intervention (PCI)(From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for First Occurrence of Any Arterial Revascularizations(From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years))
- Event Rate Per 100 Participant-years for All-cause Death(From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years))
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14(Baseline, Week 14)
- Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14(Baseline, Week 14)
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement(Baseline, last post-baseline measurement (any time up to Week 140))
- Percent Change From Baseline in Lipid Levels at Week 14(Baseline, Week 14)
- Percent Change From Baseline in Log-transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14(Baseline, Week 14)
- Percent Change From Baseline in Log-transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14(Baseline, Week 14)
研究者
研究点 (1554)
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