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Clinical Trials/NCT01975376
NCT01975376TerminatedPhase 3

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.

Pfizer1711 sites in 1 country16,784 target enrollmentStarted: October 29, 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Sponsor
Pfizer
Enrollment
16,784
Locations
1,711
Primary Endpoint
Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence 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 >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL (2.6 mmol/L).

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Must be on background lipid lowering treatment.
  • •Must be at high risk of a CV event.
  • •Must have an LDL C >/=70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 mmol/L).

Exclusion Criteria

  • •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.

Arms & Interventions

bococizumab (PF-04950615)

Experimental

150 mg, every 2 weeks, subcutaneous

Intervention: bococizumab (PF-04950615) (Drug)

Placebo

Placebo Comparator

Placebo comparator, every 2 weeks, subcutaneous.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event

Time Frame: 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 cardiovascular 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.

Secondary Outcomes

  • 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 Death, Non-Fatal Myocardial Infarction, Non-Fatal Stroke and Hospitalization for Unstable Angina(From baseline until the date of first adjudicated and confirmed occurrence of cardiovascular death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina (maximum duration: up to 3.4 years))
  • Event Rate Per 100 Participant-Years For Cardiovascular Death(From baseline until the date of adjudicated and confirmed occurrence of cardiovascular 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 MI (fatal or non-fatal) (maximum duration: up to 3.4 years))
  • Event Rate Per 100 Participant-Years For Fatal Myocardial Infarction(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(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 Composite Endpoint of Cardiovascular Death, Non-Fatal Myocardial Infraction, or Non-Fatal Stroke(From baseline until the date of first adjudicated and confirmed occurrence of the 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, 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, or Non-Fatal Stroke(From baseline until the date of first adjudicated and confirmed occurrence of the 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 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 first 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 congestive heart failure (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 at Week 14(Baseline, Week 14)
  • Nominal Change From Baseline in Low Density Lipoprotein Cholesterol at Week 14(Baseline, Week 14)
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol 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 Lipoprotein (a) (Lp[a]) and Triglycerides 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)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1711)

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