Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
- Conditions
- Hyperlipidemia
- Interventions
- Other: Placebo
- Registration Number
- NCT01968954
- 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
- 711
- 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.
- 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 Placebo Placebo - Bococizumab (PF-04950615;RN316) Bococizumab (PF-04950615;RN316) -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in 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 12 in Participants With Primary Hyperlipidemia Baseline, Week 12 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.
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia Baseline, Week 12 Participants with mixed dyslipidemia are defined as TG level greater than or equal to (\>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52 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 Baseline, Week 24, 52 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.
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in 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-C (LDL-C) at Week 12 by Trigylceride Cut-Off Baseline, Week 12 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.
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in 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 Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 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 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 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 Week 12, 24 and 52 Plasma PF-04950615 Concentrations 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 the end of study (up to 58 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 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.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Baseline up to the end of study (up to 58 weeks) 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.
Trial Locations
- Locations (103)
Horizon Research Group of Opelousas, LLC
🇺🇸Eunice, Louisiana, United States
Internal Medicine Associates
🇺🇸Eunice, Louisiana, United States
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Poland
Centrum Medyczne AMED
🇵🇱Warszawa, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
🇵🇱Wroclaw, Poland
Orange County Research Center
🇺🇸Tustin, California, United States
Soundview Medical Associates
🇺🇸Norwalk, Connecticut, United States
Montana Medical Research Inc.
🇺🇸Missoula, Montana, United States
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
🇨🇦Sherbrooke, Quebec, Canada
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
San Diego Family Care
🇺🇸San Diego, California, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Prestige Clinical Research Center Inc
🇺🇸Miami, Florida, United States
Comunity Clinical Research Center
🇺🇸Anderson, Indiana, United States
East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
🇺🇸Jacksonville, Florida, United States
Edgewater Medical Research
🇺🇸New Smyrna Beach, Florida, United States
Evanston Premier Healthcare Research LLC
🇺🇸Evanston, Illinois, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
University of MN, Lillehei Clinical Trials Unit
🇺🇸Minneapolis, Minnesota, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Clinical Trials of America, Inc.
🇺🇸Winston Salem, North Carolina, United States
The Office of Daniel G. Williams, MD
🇺🇸Perrysburg, Ohio, United States
Great Lakes Medical Research, LLC
🇺🇸Willoughby, Ohio, United States
Perelman Center for Advanced Medicine Heart & Vascular Center
🇺🇸Philadelphia, Pennsylvania, United States
Internal Medicine and Pediatric Associates of Bristol, PC
🇺🇸Bristol, Tennessee, United States
3 rd Coast Research Associates
🇺🇸Corpus Christi, Texas, United States
Texas Center For Drug Development, Inc.
🇺🇸Houston, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Utah Cardiology, P.C.
🇺🇸Layton, Utah, United States
National Clinical Research - Norfolk, Inc.
🇺🇸Norfolk, Virginia, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Australian Clinical Research Network
🇦🇺Maroubra, New South Wales, Australia
Core Research Group Pty Ltd
🇦🇺Milton, Queensland, Australia
Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I
🇮🇹Roma, RM, Italy
Lekarsky dum Ormiga
🇨🇿Zlin, Czech Republic
MD Studies, Inc.
🇺🇸Fountain Valley, California, United States
Southwest Heart Group
🇺🇸Tucson, Arizona, United States
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
Fellows Research Alliance, Inc.
🇺🇸Savannah, Georgia, United States
Encompass Clinical Research North Coast
🇺🇸Encinitas, California, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
🇺🇸Cary, North Carolina, United States
Harleysville Medical Associates
🇺🇸Harleysville, Pennsylvania, United States
Expresscare Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
Elite Clinical Trials
🇺🇸Wildomar, California, United States
Radiant Research, Inc
🇺🇸Akron, Ohio, United States
Care Partners Clinical Research, LLC
🇺🇸Jacksonville, Florida, United States
The Avenue Cardiovascular Centre
🇦🇺St. Kilda East, Victoria, Australia
Medexa Recherche
🇨🇦Victoriaville, Quebec, Canada
ALPHA Recherche Clinique
🇨🇦Quebec City, Quebec, Canada
IRCCS Centro Cardiologico Fondazione Monzino
🇮🇹Milano, MI, Italy
Integrated Medical Research, PC
🇺🇸Ashland, Oregon, United States
Berks Cardiologists, Ltd.
🇺🇸Wyomissing, Pennsylvania, United States
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Beacon Clinical Research, LLC
🇺🇸Quincy, Massachusetts, United States
SouthCoast Medical Group
🇺🇸Savannah, Georgia, United States
Allina Health System, dba Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
American Health Network of Indiana, LLC
🇺🇸Avon, Indiana, United States
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
Berkeley Family Practice
🇺🇸Moncks Corner, South Carolina, United States
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Diex Research Montreal Inc.
🇨🇦Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Kardiologie a interni lekarstvi
🇨🇿Praha 5, Czech Republic
IRCCS Istituto Auxologico Italiano
🇮🇹Milano, MI, Italy
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
🇩🇪Ludwigshafen, Germany
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
IRCCS Ospedale San Raffaele
🇮🇹Milano, MI, Italy
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Sevrance Hospital, Yeonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu-si, Gyeonggi-do, Korea, Republic of
Synexus Polska Sp. z o.o. Oddzial w Gdyni
🇵🇱Gdynia, Poland
Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.
🇵🇱Lodz, Poland
Synexus Polska Sp. z o.o Oddzial w Poznaniu
🇵🇱Poznan, Poland
Centrum Medyczne Ogrodowa Sp. z o.o.
🇵🇱Skierniewice, Poland
Yonsei University Wonju Severance Christian Hospital
🇰🇷Gangwon-Do, Korea, Republic of
Klinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
Klinische Forschung Hannover - Mitte GmbH
🇩🇪Hannover, Germany
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
🇵🇱Katowice, Mazowieckie, Poland
NZOZ Terapia Optima
🇵🇱Katowice, Slaskie, Poland
Medicus w Opolu Sp z o.o.
🇵🇱Opole, Poland
Medicome Sp. z o.o.
🇵🇱Oswiecim, Poland
Centrum Medyczne "SOPMED" Sp. z o.o.
🇵🇱Sopot, Poland
CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego
🇵🇱Warszawa, Poland
Diagnamics, Inc.
🇺🇸Encinitas, California, United States
St. Joseph's Medical Associates
🇺🇸Stockton, California, United States
Prime Care Clinical Research
🇺🇸Laguna Hills, California, United States
Clinical Research Advantage, Inc./Cassidy Medical Group - Vista
🇺🇸Vista, California, United States
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
🇮🇹Palermo, PA, Italy
ARA-Arizona Research Associates
🇺🇸Tucson, Arizona, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Cardiovascular Associates of the Southeast, LLC
🇺🇸Birmingham, Alabama, United States
Gulfcoast Medical Research Center, LLC
🇺🇸Tampa, Florida, United States
South Oklahoma Heart Research LLC
🇺🇸Oklahoma City, Oklahoma, United States
Columbia Research Group, Inc.
🇺🇸Portland, Oregon, United States
Medical Research South,LLC
🇺🇸Charleston, South Carolina, United States
The Chinese University of Hong Kong
🇭🇰Shatin, Hong Kong
Department of Medicine & Therapeutics-The Chinese University of Hong Kong
🇭🇰Shatin, NT, Hong Kong