This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
370
150 mg every 2 weeks, subcutaneous injection, 12 months
subcutaneous injection every 2 weeks for 12 months
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52
Time frame: Baseline, Week 24, 52
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IMD Medical Group
Los Angeles, California, United States
Hartford Hospital, JB704
Hartford, Connecticut, United States
Best Quality Research, Inc.
Hialeah, Florida, United States
Medical Research Center
Miami, Florida, United States
Premier Research Associate, Inc
Miami, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, United States
Om Medical
Las Vegas, Nevada, United States
The University of North Carolina at Chapel Hill Center for Heart & Vascular Care
Chapel Hill, North Carolina, United States
The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic
Chapel Hill, North Carolina, United States
...and 78 more locations
Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percent Change From Baseline in Apolipoprotein A-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 Low Density Lipoprotein (LDL-C) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Lipoprotein (a) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline, Week 12
Absolute Change From Baseline in Ratio of 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 Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52
Time frame: Week 12, 24, 52
Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52
Time frame: Week 12, 24, 52
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Time frame: Week 12, 24, 52
Number of Participants With Adverse Events 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, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above 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 Positive 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 in this outcome measure. ADA titer greater than or equal to (\>=) 6.23 were considered as ADA positive and nAb titer level \>=1.58 were considered as nAb positive.
Time frame: Baseline up to the end of study (up to 58 weeks)