Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

Phase 3

Completed

Conditions: Hyperlipidemia

Interventions: Drug: Bococizumab (PF-04950615; RN316)
Other: Placebo

Registration Number: NCT01968967

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2139

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bococizumab (PF-04950615; RN316)	Bococizumab (PF-04950615; RN316)	-
Placebo	Placebo	-

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
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	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 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	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.
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	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.
Plasma Concentration of PF-04950615 at Week 12, 24 and 52	Week 12, 24, 52	Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.
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 (log2) unit was considered to be ADA positive and nAb titer \>=1.58 (log2) unit was considered to be nAb positive.
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

Trial Locations

Locations (247): 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
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Ernest L. Hendrix, MD, PC
🇺🇸Athens, Alabama, United States