Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
- Conditions
- Hyperlipidemia
- Interventions
- Other: Placebo
- Registration Number
- NCT02100514
- Lead Sponsor
- Pfizer
- Brief Summary
This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 746
- Treated with a statin
- Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL
- High or very high risk of incurring a cardiovascular event
- Pregnant or breastfeeding females
- Cardiovascular or cerebrovascular event or procedure within 90 days
- Congestive heart failure NYHA class IV
- Poorly controlled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo - Bococizumab (PF-04950615; RN316) Bococizumab (PF-04950615; RN316) Bococizumab (PF-04950615; RN316)
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline, Week 12
- Secondary Outcome Measures
Name Time Method 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 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 Non High Density Lipoprotein Cholesterol (Non 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) by Triglycerides 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 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-I (ApoA-I) 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 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 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) by Triglycerides Cut-off of Greater Than or Equal to (>=) 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 Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) 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 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 Absolute 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 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 Plasma Concentration Versus Time Summary of PF-04950615 Week 12, 24, 52 Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions Baseline up to end of study (up to 110 weeks) 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. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period Baseline up to Week 58 Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \>=6.23 (log 2) unit was considered to be ADA positive and nAb titer \>=1.58 (log 2) unit was considered to be nAb positive.
Number of Participants Who Changed Concomitant Medication During Extension Period Week 58 follow-up to Week 110 In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period Baseline, Week 58 (follow up), 71, 84, 97, 110 Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110 Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \>=6.23 log2 unit was considered to be ADA positive and nAb titer \>=1.58 log2 unit was considered to be nAb positive.
Trial Locations
- Locations (214)
Advanced Cardiovascular, LLC Research
🇺🇸Alexander City, Alabama, United States
Advanced Cardiovascular, LLC, Research
🇺🇸Auburn, Alabama, United States
Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
🇺🇸Phoenix, Arizona, United States
Clinical Research Advantage, Inc./Family Practice Specialists, LTD
🇺🇸Phoenix, Arizona, United States
Radiant Research, Inc.
🇺🇸Santa Rosa, California, United States
Radiant Research, Inc
🇺🇸Tucson, Arizona, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
The Office of Larry Watkins, MD
🇺🇸Little Rock, Arkansas, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
lntermed Group
🇺🇸Los Angeles, California, United States
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