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

A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

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 Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Bococizumab (PF-04950615; RN316); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2139
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8T 5G4
      • Discovery Clinical Services Ltd.
  • Ontario
    • Cambridge, Ontario, Canada, N1R 7R1
      • Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation
    • Hamilton, Ontario, Canada, L8L 5G8
      • The Office of Dr. Allen Greenspoon
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • London, Ontario, Canada, N6G 2V2
      • Stroke Prevention & Atherosclerosis Research Centre (SPARC)
    • Newmarket, Ontario, Canada, L3Y 8C3
      • Newmarket Cardiology Research Group
    • Sarnia, Ontario, Canada, N7T 4X3
      • London Road Diagnostic Clinic and Medical Centre
    • Toronto, Ontario, Canada, M5C 2T2
      • St. Michael's Hospital Health Centre
  • Quebec
    • Drummondville, Quebec, Canada, J2B 7T1
      • Rhodin Recherche Clinique
    • Levis, Quebec, Canada, G6W 0M5
      • LMC Research Inc. d.b.a. Manna Research Inc.
    • Mirabel, Quebec, Canada, J7J 2K8
      • Omnispec clinical research inc.
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050012
      • Rodrigo Botero S.A.S
    • Medellin, Antioquia, Colombia, 50031
      • Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 80020
      • Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios
    • Barranquilla, Atlantico, Colombia
      • BIOMELAB Ltda.
    • Barranquilla, Atlantico, Colombia
      • IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.
  • Bolivar
    • Cartagena, Bolivar, Colombia, 130013
      • Centro de Diagnostico Cardiologico LTDA.
  • Caldas
    • Manizales, Caldas, Colombia, 17001
      • Asociacion IPS Medicos Internistas de Caldas
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Dexa Diab Servicios Medicos Ltda. IPS
    • Bogota, Cundinamarca, Colombia
      • Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA
  • Quindio
    • Armenia, Quindio, Colombia
      • Fundacion Cardiomet - CEQUIN
  • Santander
    • Floridablanca, Santander, Colombia
      • Fundacion Cardiovascular de Colombia
  • Tolima
    • Espinal, Tolima, Colombia
      • Fundación Centro de Investigaciones Biomédicas Riescard
  • Valle DEL Cauca
    • Cali, Valle DEL Cauca, Colombia, 760032
      • Centro de Investigaciones Clinicas S.A.S
• France
  • Nantes, France, 44200
    • Nouvelles Cliniques Nantaises
  • Poitiers, France, 86021
    • CHU La Milétrie
  • Toulouse cedex 9, France, 31059
    • CHU de Toulouse - Hôpital Rangueil
  • Tourcoing, France, 59200
    • Hôpital Guy Chatillez
  • Tourcoing, France, 59200
    • Hopital Guy Chatiliez
• Hungary
  • Ajka, Hungary, 8400
    • Magyar Imre Korhaz, Belgyogyaszati Szakrendeles
  • Baja, Hungary, 6500
    • Bajai Szent Rókus Kórház
  • Baja, Hungary, 6500
    • Lausmed Kft.
  • Balatonfured, Hungary, 8230
    • DRC Kft.
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft.
  • Budapest, Hungary, 1036
    • Synexus Magyarorzag Kft.
  • Gyongyos, Hungary, 3200
    • Pharma 4 Trial Kft.
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz
  • Mosonmagyarovar, Hungary, 9200
    • TaNaMed Kft.
  • Pecs, Hungary, 7623
    • Pecsi Tudomanyegyetem
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Kórház
• Lithuania
  • Kaunas, Lithuania, LT-48259
    • PI Kaunas Silainiai Outpatient Clinic
  • Kaunas, Lithuania, LT-50177
    • Private Clinic Elite Medicale
  • Klaipeda, Lithuania, LT-92288
    • PI Klaipeda Seamen Hospital
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santariskiu Klinikos
• Mexico
  • Aguascalientes, Mexico, 20230
    • Centenario Hospital Miguel Hidalgo
  • Aguascalientes, Mexico, 20230
    • Centro Hospitalario Mac, S.A. De C.V. (Emergencies)
  • Aguascalientes, Mexico, 20230
    • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
  • San Luis Potosi, Mexico, 78200
    • Hospital Angeles Centro Medico del Potosi (Emergencies)
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 03300
      • Clinicos Asociados BOCM, S.C.
  • Estado DE Mexico
    • Naucalpan, Estado DE Mexico, Mexico, 35510
      • Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62250
      • Instituto de Diabetes, Obesidad y Nutrición S.C.
    • Cuernavaca, Morelos, Mexico, 62270
      • Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca
  • SAN LUIS Potosi
    • San Luis Potosí, SAN LUIS Potosi, Mexico, 78200
      • Centro de Atención e Investigación Cardiovascular del Potosí S.C.
• Romania
  • Brasov, Romania, 500283
    • Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna
  • Bucuresti, Romania, 010825
    • Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"
  • Cluj-Napoca, Romania, 400349
    • Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice
  • Ploiesti, Romania, 100018
    • Elit Medical SRL
  • Dolj
    • Craiova, Dolj, Romania, 200642
      • Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie
• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular
  • Moscow, Russian Federation, 117292
    • FSAEI of Higher Education "People's Friendship University of Russia",
  • Saint-Petersburg, Russian Federation, 197706
    • Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi
  • Saint-Petersburg, Russian Federation, 198205
    • Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"
  • Saratov, Russian Federation, 410039
    • Municipal Institution of Healthcare "City Clinical Hospital 12
  • St. Petersburg, Russian Federation, 196084
    • LLC "Institute of medical research"
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Unidad Metabolico-Vascular
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Miguel Servet; Medicina Interna
  • Alicante
    • Petrer, Alicante, Spain, 03610
      • Centro Salud Petrer I
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Hospital Clinico Universitario Santiago de Compostela
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Universitario Quiron Madrid
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Hospital Universitario Sant Joan de Reus
  • Valencia
    • Alzira, Valencia, Spain, 46600
      • Hospital Universitario La Ribera
• Taiwan
  • New Taipei City, Taiwan, 23148
    • Cardinal Tien Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 0TG
      • Synexus Thames Valley Clinical Research Centre
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M15 6SX
      • Synexus Manchester Clinical Research Centre
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G20 0SP
      • Synexus Scotland Clinical Research Centre
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 7NA
      • Synexus Lancashire Clinical Research Centre
  • Llanishen
    • Cardiff, Llanishen, United Kingdom, CF14 5GJ
      • Synexus Wales Clinical Research Centre
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L22 0LG
      • Synexus Merseyside Clinical Research Centre
  • Northern Ireland
    • Antrim, Northern Ireland, United Kingdom, BT41 3AE
      • Northmed Clinical Research Ltd, Randalstown Health Centre
    • Portadown, Northern Ireland, United Kingdom, BT63 5QQ
      • Southern Health & Social Care Trust, Craigavon Area Hospital
  • Northumberland
    • Hexham, Northumberland, United Kingdom, NE46 1QJ
      • Synexus North East Clinical Research Centre-Hexham General Hospital
    • Hexham, Northumberland, United Kingdom, NE46 1QJ
      • Synexus North East Clinical Research Centre
  • Surrey
    • Addlestone, Surrey, United Kingdom, KT15 2BH
      • The Crouch Oak Family Practice
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B15 2SQ
      • Synexus Midlands Clinical Research Centre
  • Wiltshire
    • Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
      • The Bradford on Avon & Melksham Health Partnership
• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center, LLC
    • Athens, Alabama, United States, 35611
      • Ernest L. Hendrix, MD, PC
    • Birmingham, Alabama, United States, 35233
      • The Kirklin Clinic
    • Birmingham, Alabama, United States, 35235
      • Alabama Internal Medicine, P.C.
    • Birmingham, Alabama, United States, 35294
      • Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research Incorporated
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates
    • Mesa, Arizona, United States, 85205
      • Arizona Center For Internal Medicine
    • Peoria, Arizona, United States, 85381
      • Holland Center for Family Health
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
    • Phoenix, Arizona, United States, 85021
      • Phoenix Clinical
    • Tucson, Arizona, United States, 85712
      • Advanced Arizona Clinical Research
    • Tucson, Arizona, United States, 85710
      • Desert Sun Clinical Research, LLC
  • California
    • Banning, California, United States, 92220
      • Care Clinical Research Corporation
    • Carmichael, California, United States, 95608
      • Med Center
    • Fair Oaks, California, United States, 95628
      • MED Investigations
    • Huntington Beach, California, United States, 92648
      • California Heart Specialists
    • Huntington Park, California, United States, 90255
      • Alia Clinical Research, Inc.
    • Los Angeles, California, United States, 90017
      • Downtown L.A. Research Center, Inc.
    • Los Gatos, California, United States, 95032
      • Richard S. Cherlin, M.D.
    • Northridge, California, United States, 91324
      • California Medical Research Associates Inc.
    • Poway, California, United States, 92064
      • Arch Health Partners Clinical Research Department
    • Sacramento, California, United States, 95821
      • Northern California Research
    • Sacramento, California, United States, 95821
      • Clinical Trials Research
    • Simi Valley, California, United States, 93065
      • Alta California Medical Group
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Upland, California, United States, 91786
      • Empire Clinical Research
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
    • West Hills, California, United States, 91307
      • Infosphere Clinical Research, Inc
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Clinicos, LLC
    • Colorado Springs, Colorado, United States, 80906
      • Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW
  • Connecticut
    • North Haven, Connecticut, United States, 06473
      • YNHH, Heart and Vascular
  • Florida
    • Atlantis, Florida, United States, 33462
      • ACRC-Cardiology
    • Clearwater, Florida, United States, 33756
      • Morton Plant Mease Health Care, Inc. Cardiovascular Research
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Fleming Island, Florida, United States, 32003
      • Fleming Island Center for Clinical Research
    • Fort Lauderdale, Florida, United States, 33308
      • InvesClinic, LLC
    • Gainesville, Florida, United States, 32605
      • Florida Research Network, LLC
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials
    • Hialeah, Florida, United States, 33013
      • The Research Center, Inc.
    • Homestead, Florida, United States, 33030
      • Homestead Medical Research Inc.
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Jacksonville, Florida, United States, 32205
      • Westside Center for Clinical Research
    • Jacksonville, Florida, United States, 32216
      • St. Vincent's Cardiology
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
    • Miami, Florida, United States, 33144
      • Medical Research Center
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic, Inc.
    • Miami, Florida, United States, 33126
      • Finlay Medical Research
    • Miami, Florida, United States, 33185
      • Kendall South Medical Center
    • Miami, Florida, United States, 33126
      • Clinical Research of Miami
    • Orlando, Florida, United States, 32825
      • Florida Institute for Clinical Research, LLC
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research, LLC
    • Pembroke Pines, Florida, United States, 33024
      • A&R Research Group, LLC
    • Pembroke Pines, Florida, United States, 33029
      • DBC Research
    • Ponte Vedra, Florida, United States, 32081
      • St. Johns Center for Clinical Research
    • South Miami, Florida, United States, 33143
      • South Miami Clinical Research Center, LLC
    • Virginia Gardens, Florida, United States, 33166
      • Dolphin Medical Research
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute Incorporated
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Roswell, Georgia, United States, 30075
      • Atlanta Center for Clinical Research / Internal Medicine
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
    • Woodstock, Georgia, United States, 30189
      • North Georgia Internal Medicine
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials, Inc.
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Investigators Research Group, LLC
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
    • Indianapolis, Indiana, United States, 46254
      • American Health Network, LLC
    • Valparaiso, Indiana, United States, 46383
      • Buynak Clinical Research, P.C.
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • West Broadway Clinic
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa - College of Public Health - Preventive Intervention Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Overland Park, Kansas, United States, 66215
      • Midwest Heart and Vascular Specialists
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Omega Clinical Research
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
  • Maine
    • Biddeford, Maine, United States, 04005
      • Southern Maine Health Care
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Columbia Medical Practice
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
  • Michigan
    • Chelsea, Michigan, United States, 48118
      • IHA Chelsea Family & Internal Medicine
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
    • Kalamazoo, Michigan, United States, 49009
      • Westside Family Medical Center, Pc
    • Petoskey, Michigan, United States, 49770
      • Michigan Heart And Vascular Specialists
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research Center
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research, Inc.
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast Medical Research Institute
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital Pharmacy
  • Missouri
    • Kansas City, Missouri, United States, 64106
      • KCUMB Center for Community and Clinical Research
    • Washington, Missouri, United States, 63090
      • Mercy Health Research
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Clinical Research of South Nevada
    • Las Vegas, Nevada, United States, 89119
      • Om Medical
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School
    • Somerset, New Jersey, United States, 08873
      • Cardio Metabolic Institute
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • New York
    • Albany, New York, United States, 12206
      • Albany Medical College, Division of Community Endocrinology
    • Brooklyn, New York, United States, 11230
      • Drug Trials Brooklyn
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
    • Liverpool, New York, United States, 13088
      • SJH Cardiology Associates
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research, PLLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Sensenbrenner Primary Care
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • Mooresville, North Carolina, United States, 28117
      • Crossroads Clinical Research, Inc.
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc
    • Canal Fulton, Ohio, United States, 44614
      • Community Health Care, Inc.
    • Cincinnati, Ohio, United States, 45236
      • Sentral Clinical Research Services
    • Cincinnati, Ohio, United States, 45246
      • Sterling Research Group, Ltd.
    • Cincinnati, Ohio, United States, 45227
      • Metabolic and Atherosclerosis Research Center
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group, Ltd.
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Center for Research and Education at The Christ Hospital
    • Cincinnati, Ohio, United States, 45236
      • Sentral Clinical Research Services - Admin Only
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Lion Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon, PC
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335
      • Brandywine Clinical Research
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Erie, Pennsylvania, United States, 16508
      • Liberty Family Practice
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine and Associates, PC
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Endocrinology Associates
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group, PC
    • Warminster, Pennsylvania, United States, 18974
      • Warminster Medical Associates, P.C.
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Coastal Cardiology
    • Greenville, South Carolina, United States, 29615
      • Upstate Pharmaceutical Research
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
    • Knoxville, Tennessee, United States, 37917
      • Cardiovascular Research of Knoxville
  • Texas
    • Arlington, Texas, United States, 76012
      • KRK Medical Research
    • Dallas, Texas, United States, 75231
      • Research Institute Of Dallas
    • Dallas, Texas, United States, 75216
      • North Texas Healthcare System, Dallas VAMC
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Science Center at Fort Worth
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions, Inc.
    • Houston, Texas, United States, 77070
      • Northwest Houston Cardiology
    • Houston, Texas, United States, 77030
      • lnvestigational Drug Services (IDA)
    • New Braunfels, Texas, United States, 78130
      • Hill Country Medical Associates
    • Plano, Texas, United States, 75093
      • Advanced Clinical Research Associates
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • San Antonio, Texas, United States, 78249
      • Bandera Family Health Care, LLC
    • Tomball, Texas, United States, 77375
      • Northwest Heart Center
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Richmond, Virginia, United States, 23294
      • National Clinical Research-Richmond, Inc.
    • Winchester, Virginia, United States, 22601
      • Selma Medical Associates
    • Winchester, Virginia, United States, 22601
      • Amherst Family Practice, P.C.
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center
    • Richland, Washington, United States, 99352
      • Zain Research LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; subcutaneous injection every 2 weeks for 12 months
Experimental: Bococizumab (PF-04950615; RN316)	Drug: Bococizumab (PF-04950615; RN316); 150 mg every 2 weeks, subcutaneous injection, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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) 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 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-I (ApoA-I) 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
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 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) by Triglycerides Cut-off of Greater Than or Equal to (>=) 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 Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12		Baseline, Week 12
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) 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
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
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
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
Plasma Concentration of PF-04950615 at Week 12, 24 and 52	Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.	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.	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.	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.	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		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.	Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2013
• Primary Completion (Actual): July 5, 2016
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: mixed dyslipidemia; high risk of cardiovascular events; multiple cardiovascular disease risk factors
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Bococizumab
• Other Study ID Numbers: B1481020; 2013-002643-28 (EudraCT Number); SPIRE-LDL (Other Identifier: Alias Study Number)