Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Phase 3CompletedNCT01968954

Pfizer711 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

711

Conditions

Hyperlipidemia

Interventions

Bococizumab (PF-04950615;RN316)DRUG

150 mg every 2 weeks, subcutaneous injection, 12 months

PlaceboOTHER

subcutaneous injection, every 2 weeks for 12 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (103)

Outcomes

Primary Outcomes

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

Time frame: Baseline, Week 12

Secondary Outcomes

Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

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

Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (\<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre \[mmol/L\]) at pre-randomization.

Time frame: Baseline, Week 12

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

Participants with mixed dyslipidemia are defined as TG level greater than or equal to (\>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.

Data from ClinicalTrials.gov

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Achieve Clinical Research, LLC

Birmingham, Alabama, United States

Cardiovascular Associates of the Southeast, LLC

Birmingham, Alabama, United States

Southwest Heart Group

Tucson, Arizona, United States

ARA-Arizona Research Associates

Tucson, Arizona, United States

Diagnamics, Inc.

Encinitas, California, United States

Encompass Clinical Research North Coast

Encinitas, California, United States

MD Studies, Inc.

Fountain Valley, California, United States

Alliance Research Centers

Laguna Hills, California, United States

Prime Care Clinical Research

Laguna Hills, California, United States

Providence Clinical Research

North Hollywood, California, United States

...and 93 more locations

Time frame: Baseline, Week 12

Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

Time frame: Baseline, Week 24, 52

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

Percent change from baseline in fasting LDL-C among participants with TG cut-off of \<200 mg/dL and \>=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.

Time frame: Baseline, Week 24, 52

Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off

Absolute change from baseline among participants with TG cut-off of \<200 mg/dL and \>=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.

Time frame: Baseline, Week 12

Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52

Time frame: Baseline, Week 12, 24, 52

Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52

Time frame: Week 12, 24 and 52

Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52

Time frame: Week 12, 24 and 52

Plasma PF-04950615 Concentrations at Week 12, 24 and 52

Time frame: Week 12, 24, 52

Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.

Time frame: Baseline up to the end of study (up to 58 weeks)

Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer \>=6.23 were considered to be ADA positive and participants with their nAb titer \>=1.58 were considered to be nAb positive.

Time frame: Baseline up to the end of study (up to 58 weeks)