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Clinical Trials/NCT01968967
NCT01968967CompletedPhase 3

A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Pfizer247 sites in 1 country2,139 target enrollmentStarted: October 29, 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Pfizer
Enrollment
2,139
Locations
247
Primary Endpoint
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
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

  • •Treated with a statin.
  • •Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
  • •High or very high risk of incurring a cardiovascular event.

Exclusion Criteria

  • •Pregnant or breastfeeding females.
  • •Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • •Congestive heart failure NYHA class IV.
  • •Poorly controlled hypertension.

Arms & Interventions

Bococizumab (PF-04950615; RN316)

Experimental

Intervention: Bococizumab (PF-04950615; RN316) (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time Frame: Baseline, Week 12

Secondary Outcomes

  • Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period(Baseline, Week 24, 52)
  • Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline, Week 12)
  • Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12(Baseline, Week 12)
  • Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline, Week 12)
  • Number of Participants Who Changed Concomitant Medication During Extension Period(Week 58 follow-up visit to Week 110)
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period(Baseline, Week 58 follow-up visit, 71, 84, 97, 110)
  • Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12(Baseline, Week 12)
  • Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12(Baseline, Week 12)
  • Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12(Baseline, Week 12)
  • Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12(Baseline, Week 12)
  • Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Week 12, 24, 52)
  • Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period(Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110)
  • Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12(Baseline, Week 12)
  • Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52(Week 12, 24, 52)
  • Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions(Baseline up to Week 58)
  • Plasma Concentration of PF-04950615 at Week 12, 24 and 52(Week 12, 24, 52)
  • Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period(Baseline up to Week 58)
  • Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
  • Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (247)

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