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
2,139
150 mg every 2 weeks, subcutaneous injection, 12 months
subcutaneous injection every 2 weeks for 12 months
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Non 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) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) 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) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting 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 24, 52: Treatment Period
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Ernest L. Hendrix, MD, PC
Athens, Alabama, United States
North Alabama Research Center, LLC
Athens, Alabama, United States
The Kirklin Clinic
Birmingham, Alabama, United States
Alabama Internal Medicine, P.C.
Birmingham, Alabama, United States
Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham
Birmingham, Alabama, United States
Heart Center Research, Llc
Huntsville, Alabama, United States
Radiant Research Incorporated
Chandler, Arizona, United States
Advanced Research Associates
Glendale, Arizona, United States
Arizona Center For Internal Medicine
Mesa, Arizona, United States
Holland Center for Family Health
Peoria, Arizona, United States
...and 239 more locations
Time frame: Baseline, Week 24, 52
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting 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 Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12
Time frame: 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
Time frame: Baseline, Week 12
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: 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
Time frame: 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
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 (mg/dL) at Week 12, 24 and 52
Time frame: Week 12, 24, 52
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
Time frame: Week 12, 24, 52
Plasma Concentration of PF-04950615 at Week 12, 24 and 52
Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.
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. 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.
Time frame: Baseline up to Week 58
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
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.
Time frame: Baseline up to Week 58
Number of Participants Who Changed Concomitant Medication During Extension Period
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.
Time frame: 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
Time frame: Baseline, Week 58 follow-up visit, 71, 84, 97, 110
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
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.
Time frame: Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110