Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
NCT ID: NCT01968967
Last Updated: 2018-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2139 participants
INTERVENTIONAL
2013-10-29
2017-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bococizumab (PF-04950615; RN316)
Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Placebo
Placebo
subcutaneous injection every 2 weeks for 12 months
Interventions
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Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Placebo
subcutaneous injection every 2 weeks for 12 months
Eligibility Criteria
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Inclusion Criteria
* Fasting LDL-C \> 70 mg/dL and triglyceride \<=400 mg/dL.
* High or very high risk of incurring a cardiovascular event.
Exclusion Criteria
* Cardiovascular or cerebrovascular event of procedures during the past 30 days.
* Congestive heart failure NYHA class IV.
* Poorly controlled hypertension.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Phoenix Clinical
Phoenix, Arizona, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
Advanced Arizona Clinical Research
Tucson, Arizona, United States
Care Clinical Research Corporation
Banning, California, United States
Med Center
Carmichael, California, United States
Med Investigations
Fair Oaks, California, United States
California Heart Specialists
Huntington Beach, California, United States
Alia Clinical Research, Inc.
Huntington Park, California, United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States
Richard S. Cherlin, M.D.
Los Gatos, California, United States
California Medical Research Associates Inc.
Northridge, California, United States
Arch Health Partners Clinical Research Department
Poway, California, United States
Clinical Trials Research
Sacramento, California, United States
Northern California Research
Sacramento, California, United States
Alta California Medical Group
Simi Valley, California, United States
Orange County Research Center
Tustin, California, United States
Empire Clinical Research
Upland, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Infosphere Clinical Research, INC
West Hills, California, United States
Clinicos, LLC
Colorado Springs, Colorado, United States
Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW
Colorado Springs, Colorado, United States
YNHH, Heart and Vascular
North Haven, Connecticut, United States
ACRC-Cardiology
Atlantis, Florida, United States
Morton Plant Mease Health Care, Inc. Cardiovascular Research
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Invesclinic, LLC
Fort Lauderdale, Florida, United States
Florida Research Network, LLC
Gainesville, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
The Research Center, Inc.
Hialeah, Florida, United States
Homestead Medical Research Inc.
Homestead, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA
Jacksonville, Florida, United States
East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center
Jacksonville, Florida, United States
East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic
Jacksonville, Florida, United States
East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
Jacksonville, Florida, United States
St. Vincent's Cardiology
Jacksonville, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Clinical Research of Miami
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Medical Research Center
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Kendall South Medical Center
Miami, Florida, United States
Florida Institute For Clinical Research, LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
A&R Research Group, LLC
Pembroke Pines, Florida, United States
DBC Research
Pembroke Pines, Florida, United States
St. Johns Center for Clinical Research
Ponte Vedra, Florida, United States
South Miami Clinical Research Center, LLC
South Miami, Florida, United States
Dolphin Medical Research
Virginia Gardens, Florida, United States
Metabolic Research Institute Incorporated
West Palm Beach, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Atlanta Center for Clinical Research / Internal Medicine
Roswell, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
North Georgia Internal Medicine
Woodstock, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
Investigators Research Group, LLC
Brownsburg, Indiana, United States
American Health Network, LLC
Indianapolis, Indiana, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
The University of Iowa - College of Public Health - Preventive Intervention Center
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
Omega Clinical Research
Metairie, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
Southern Maine Health Care
Biddeford, Maine, United States
Columbia Medical Practice
Columbia, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
IHA Chelsea Family & Internal Medicine
Chelsea, Michigan, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Westside Family Medical Center, Pc
Kalamazoo, Michigan, United States
Michigan Heart and Vascular Specialists
Petoskey, Michigan, United States
Oakland Medical Research Center
Troy, Michigan, United States
Radiant Research, Inc.
Edina, Minnesota, United States
HealthEast Medical Research Institute
Saint Paul, Minnesota, United States
HealthEast St. Joseph's Hospital Pharmacy
Saint Paul, Minnesota, United States
KCUMB Center for Community and Clinical Research
Kansas City, Missouri, United States
Mercy Health Research
Washington, Missouri, United States
Om Medical
Las Vegas, Nevada, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Cardio Metabolic Institute
Somerset, New Jersey, United States
Premier Research
Trenton, New Jersey, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, United States
Drug Trials Brooklyn
Brooklyn, New York, United States
Drug Trials America
Hartsdale, New York, United States
SJH Cardiology Associates
Liverpool, New York, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
Sensenbrenner Primary Care
Charlotte, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
Crossroads Clinical Research, Inc.
Mooresville, North Carolina, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Radiant Research, Inc
Akron, Ohio, United States
Community Health Care, Inc.
Canal Fulton, Ohio, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States
Sentral Clinical Research Services - Admin Only
Cincinnati, Ohio, United States
Sentral Clinical Research Services
Cincinnati, Ohio, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
LION Research
Norman, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Liberty Family Practice
Erie, Pennsylvania, United States
Detweiler Family Medicine and Associates, PC
Lansdale, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States
Warminster Medical Associates, P.C.
Warminster, Pennsylvania, United States
Coastal Cardiology
Charleston, South Carolina, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Cardiovascular Research of Knoxville
Knoxville, Tennessee, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
KRK Medical Research
Arlington, Texas, United States
North Texas Healthcare System, Dallas VAMC
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
lnvestigational Drug Services (IDA)
Houston, Texas, United States
Northwest Houston Cardiology
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Hill Country Medical Associates
New Braunfels, Texas, United States
Advanced Clinical Research Associates
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Bandera Family Health Care, LLC
San Antonio, Texas, United States
Northwest Heart Center
Tomball, Texas, United States
Radiant Research
Murray, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States
Amherst Family Practice, P.C.
Winchester, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Zain Research LLC
Richland, Washington, United States
Discovery Clinical Services Ltd.
Victoria, British Columbia, Canada
Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation
Cambridge, Ontario, Canada
The Office of Dr. Allen Greenspoon
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Stroke Prevention & Atherosclerosis Research Centre (SPARC)
London, Ontario, Canada
Newmarket Cardiology Research Group
Newmarket, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
St. Michael's Hospital Health Centre
Toronto, Ontario, Canada
Rhodin Recherche Clinique
Drummondville, Quebec, Canada
LMC Research Inc. d.b.a. Manna Research Inc.
Lévis, Quebec, Canada
Omnispec Clinical Research Inc.
Mirabel, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
DIEX Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Rodrigo Botero S.A.S
Medellín, Antioquia, Colombia
Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.
Medellín, Antioquia, Colombia
Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios
Barranquilla, Atlántico, Colombia
BIOMELAB Ltda.
Barranquilla, Atlántico, Colombia
IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.
Barranquilla, Atlántico, Colombia
Asociacion IPS Medicos InterniStas de Caldas
Manizales, Caldas Department, Colombia
Dexa Diab Servicios Medicos Ltda. IPS
Bogota, Cundinamarca, Colombia
Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA
Bogota, Cundinamarca, Colombia
Centro de Diagnostico Cardiologico LTDA.
Cartagena, Departamento de Bolívar, Colombia
Fundacion Cardiomet - CEQUIN
Armenia, Quindío Department, Colombia
Fundacion Cardiovascular De Colombia
Floridablanca, Santander Department, Colombia
Fundacion Centro de Investigaciones Biomedicas RIESCARD
Espinal, Tolima Department, Colombia
Centro de Investigaciones Clinicas S.A.S
Cali, Valle del Cauca Department, Colombia
Nouvelles Cliniques Nantaises
Nantes, , France
CHU La Miletrie
Poitiers, , France
CHU de Toulouse - Hopital Rangueil
Toulouse, , France
Hopital Guy Chatiliez
Tourcoing, , France
Hopital Guy Chatillez
Tourcoing, , France
Magyar Imre Korhaz, Belgyogyaszati Szakrendeles
Ajka, , Hungary
Bajai Szent Rokus Korhaz
Baja, , Hungary
Lausmed Kft.
Baja, , Hungary
DRC Kft.
Balatonfüred, , Hungary
SYNEXUS Magyarorszag Kft.
Budapest, , Hungary
Synexus Magyarorzag Kft.
Budapest, , Hungary
Pharma 4 Trial Kft.
Gyöngyös, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz
Miskolc, , Hungary
TaNaMed Kft.
Mosonmagyaróvár, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
Zala Megyei Korhaz
Zalaegerszeg, , Hungary
PI Kaunas Silainiai Outpatient Clinic
Kaunas, , Lithuania
Private Clinic Elite Medicale
Kaunas, , Lithuania
PI Klaipeda Seamen Hospital
Klaipėda, , Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.
Guadalajara, Jalisco, Mexico
Clinicos Asociados BOCM, S.C.
Mexico City, Mexico City, Mexico
Instituto de Diabetes, Obesidad y Nutricion S.C.
Cuernavaca, Morelos, Mexico
Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca
Cuernavaca, Morelos, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, San Luis Potosí, Mexico
Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)
Naucalpan, State of Mexico, Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, , Mexico
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
Aguascalientes, , Mexico
Centro Hospitalario Mac, S.A. De C.V. (Emergencies)
Aguascalientes, , Mexico
Hospital Angeles Centro Medico del Potosi (Emergencies)
San Luis Potosí City, , Mexico
Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie
Craiova, Dolj, Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna
Brasov, , Romania
Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"
Bucharest, , Romania
Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice
Cluj-Napoca, , Romania
Elit Medical SRL
Ploieşti, , Romania
Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular
Kemerovo, , Russia
FSAEI of Higher Education "People's Friendship University of Russia",
Moscow, , Russia
LLC "Institute of medical research"
Saint Petersburg, , Russia
Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi
Saint Petersburg, , Russia
Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"
Saint Petersburg, , Russia
Municipal Institution of Healthcare "City Clinical Hospital 12
Saratov, , Russia
Centro Salud Petrer I
Petrel, Alicante, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, Galicia, Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Universitario La Ribera
Alzira, Valencia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz; Unidad Metabolico-Vascular
Madrid, , Spain
Hospital Clinico Universitario Miguel Servet; Medicina Interna
Zaragoza, , Spain
Cardinal Tien Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Synexus Thames Valley Clinical Research Centre
Reading, Berkshire, United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, Greater Manchester, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, Lanarkshire, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, Llanishen, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool, Merseyside, United Kingdom
Northmed Clinical Research Ltd, Randalstown Health Centre
Antrim, Northern Ireland, United Kingdom
Southern Health & Social Care Trust, Craigavon Area Hospital
Portadown, Northern Ireland, United Kingdom
Synexus North East Clinical Research Centre-Hexham General Hospital
Hexham, Northumberland, United Kingdom
Synexus North East Clinical Research Centre
Hexham, Northumberland, United Kingdom
The Crouch Oak Family Practice
Addlestone, Surrey, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham, WEST Midlands, United Kingdom
The Bradford on Avon & Melksham Health Partnership
Bradford-on-Avon, Wiltshire, United Kingdom
Ninewells Hospital & Medical School
Dundee, , United Kingdom
Countries
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References
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Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
McCush F, Wang E, Yunis C, Schwartz P, Baltrukonis D. Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study. AAPS J. 2023 Sep 2;25(5):85. doi: 10.1208/s12248-023-00846-x.
Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.
Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-002643-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPIRE-LDL
Identifier Type: OTHER
Identifier Source: secondary_id
B1481020
Identifier Type: -
Identifier Source: org_study_id
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