Clinical trial NCT01968967: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: mixed dyslipidemia
high risk of cardiovascular events
multiple cardiovascular disease risk factors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-10-24
Enrollment: 2139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: 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
timeFrame: Baseline, Week 12, 24, 52
measure: 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
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period
timeFrame: Baseline, Week 24, 52
measure: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: 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
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: 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
timeFrame: Week 12, 24, 52
measure: 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
timeFrame: Week 12, 24, 52
measure: Plasma Concentration of PF-04950615 at Week 12, 24 and 52
timeFrame: Week 12, 24, 52
measure: Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
timeFrame: Baseline up to Week 58
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
timeFrame: Baseline up to Week 58
measure: Number of Participants Who Changed Concomitant Medication During Extension Period
timeFrame: Week 58 follow-up visit to Week 110
measure: 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
timeFrame: Baseline, Week 58 follow-up visit, 71, 84, 97, 110
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
timeFrame: Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ernest L. Hendrix, MD, PC
state: Alabama
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
city: Birmingham
country: United States
facility: Alabama Internal Medicine, P.C.
state: Alabama
city: Birmingham
country: United States
facility: Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, Llc
state: Alabama
city: Chandler
country: United States
facility: Radiant Research Incorporated
state: Arizona
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Mesa
country: United States
facility: Arizona Center For Internal Medicine
state: Arizona
city: Peoria
country: United States
facility: Holland Center for Family Health
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Advanced Arizona Clinical Research
state: Arizona
city: Banning
country: United States
facility: Care Clinical Research Corporation
state: California
city: Carmichael
country: United States
facility: Med Center
state: California
city: Fair Oaks
country: United States
facility: Med Investigations
state: California
city: Huntington Beach
country: United States
facility: California Heart Specialists
state: California
city: Huntington Park
country: United States
facility: Alia Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center, Inc.
state: California
city: Los Gatos
country: United States
facility: Richard S. Cherlin, M.D.
state: California
city: Northridge
country: United States
facility: California Medical Research Associates Inc.
state: California
city: Poway
country: United States
facility: Arch Health Partners Clinical Research Department
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Simi Valley
country: United States
facility: Alta California Medical Group
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: West Hills
country: United States
facility: Infosphere Clinical Research, INC
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW
state: Colorado
city: North Haven
country: United States
facility: YNHH, Heart and Vascular
state: Connecticut
city: Atlantis
country: United States
facility: ACRC-Cardiology
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Mease Health Care, Inc. Cardiovascular Research
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinic, LLC
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: The Research Center, Inc.
state: Florida
city: Homestead
country: United States
facility: Homestead Medical Research Inc.
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Cardiology
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Clinical Research of Miami
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: Medical Research Center
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Institute For Clinical Research, LLC
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: A&R Research Group, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research
state: Florida
city: Ponte Vedra
country: United States
facility: St. Johns Center for Clinical Research
state: Florida
city: South Miami
country: United States
facility: South Miami Clinical Research Center, LLC
state: Florida
city: Virginia Gardens
country: United States
facility: Dolphin Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Incorporated
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Roswell
country: United States
facility: Atlanta Center for Clinical Research / Internal Medicine
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal Medicine
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Boise
country: United States
facility: Northwest Clinical Trials, Inc.
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Indianapolis
country: United States
facility: American Health Network, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C.
state: Indiana
city: Council Bluffs
country: United States
facility: West Broadway Clinic
state: Iowa
city: Iowa City
country: United States
facility: The University of Iowa - College of Public Health - Preventive Intervention Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Midwest Heart and Vascular Specialists
state: Kansas
city: Metairie
country: United States
facility: Omega Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Biddeford
country: United States
facility: Southern Maine Health Care
state: Maine
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Chelsea
country: United States
facility: IHA Chelsea Family & Internal Medicine
state: Michigan
city: Farmington Hills
country: United States
facility: QUEST Research Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, Pc
state: Michigan
city: Petoskey
country: United States
facility: Michigan Heart and Vascular Specialists
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast Medical Research Institute
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital Pharmacy
state: Minnesota
city: Kansas City
country: United States
facility: KCUMB Center for Community and Clinical Research
state: Missouri
city: Washington
country: United States
facility: Mercy Health Research
state: Missouri
city: Las Vegas
country: United States
facility: Om Medical
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School
state: New Jersey
city: Somerset
country: United States
facility: Cardio Metabolic Institute
state: New Jersey
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College, Division of Community Endocrinology
state: New York
city: Brooklyn
country: United States
facility: Drug Trials Brooklyn
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: Charlotte
country: United States
facility: Sensenbrenner Primary Care
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Mooresville
country: United States
facility: Crossroads Clinical Research, Inc.
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Akron
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Canal Fulton
country: United States
facility: Community Health Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Metabolic and Atherosclerosis Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services - Admin Only
state: Ohio
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Norman
country: United States
facility: LION Research
state: Oklahoma
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Erie
country: United States
facility: Liberty Family Practice
state: Pennsylvania
city: Lansdale
country: United States
facility: Detweiler Family Medicine and Associates, PC
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group, PC
state: Pennsylvania
city: Warminster
country: United States
facility: Warminster Medical Associates, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Cardiology
state: South Carolina
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Knoxville
country: United States
facility: Cardiovascular Research of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Arlington
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: North Texas Healthcare System, Dallas VAMC
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center at Fort Worth
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: lnvestigational Drug Services (IDA)
state: Texas
city: Houston
country: United States
facility: Northwest Houston Cardiology
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
city: Plano
country: United States
facility: Advanced Clinical Research Associates
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Bandera Family Health Care, LLC
state: Texas
city: Tomball
country: United States
facility: Northwest Heart Center
state: Texas
city: Murray
country: United States
facility: Radiant Research
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research-Richmond, Inc.
state: Virginia
city: Winchester
country: United States
facility: Amherst Family Practice, P.C.
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Richland
country: United States
facility: Zain Research LLC
state: Washington
city: Victoria
country: Canada
facility: Discovery Clinical Services Ltd.
state: British Columbia
city: Cambridge
country: Canada
facility: Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation
state: Ontario
city: Hamilton
country: Canada
facility: The Office of Dr. Allen Greenspoon
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Stroke Prevention & Atherosclerosis Research Centre (SPARC)
state: Ontario
city: Newmarket
country: Canada
facility: Newmarket Cardiology Research Group
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital Health Centre
state: Ontario
city: Drummondville
country: Canada
facility: Rhodin Recherche Clinique
state: Quebec
city: Levis
country: Canada
facility: LMC Research Inc. d.b.a. Manna Research Inc.
state: Quebec
city: Mirabel
country: Canada
facility: Omnispec Clinical Research Inc.
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: DIEX Research Sherbrooke Inc.
state: Quebec
city: Medellin
country: Colombia
facility: Rodrigo Botero S.A.S
state: Antioquia
city: Medellin
country: Colombia
facility: Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.
state: Antioquia
city: Barranquilla
country: Colombia
facility: Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios
state: Atlantico
city: Barranquilla
country: Colombia
facility: BIOMELAB Ltda.
state: Atlantico
city: Barranquilla
country: Colombia
facility: IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.
state: Atlantico
city: Cartagena
country: Colombia
facility: Centro de Diagnostico Cardiologico LTDA.
state: Bolivar
city: Manizales
country: Colombia
facility: Asociacion IPS Medicos InterniStas de Caldas
state: Caldas
city: Bogota
country: Colombia
facility: Dexa Diab Servicios Medicos Ltda. IPS
state: Cundinamarca
city: Bogota
country: Colombia
facility: Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA
state: Cundinamarca
city: Armenia
country: Colombia
facility: Fundacion Cardiomet - CEQUIN
state: Quindio
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular De Colombia
state: Santander
city: Espinal
country: Colombia
facility: Fundacion Centro de Investigaciones Biomedicas RIESCARD
state: Tolima
city: Cali
country: Colombia
facility: Centro de Investigaciones Clinicas S.A.S
state: Valle DEL Cauca
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Poitiers
country: France
facility: CHU La Miletrie
city: Toulouse cedex 9
country: France
facility: CHU de Toulouse - Hopital Rangueil
city: Tourcoing
country: France
facility: Hopital Guy Chatiliez
city: Tourcoing
country: France
facility: Hopital Guy Chatillez
city: Ajka
country: Hungary
facility: Magyar Imre Korhaz, Belgyogyaszati Szakrendeles
city: Baja
country: Hungary
facility: Bajai Szent Rokus Korhaz
city: Baja
country: Hungary
facility: Lausmed Kft.
city: Balatonfured
country: Hungary
facility: DRC Kft.
city: Budapest
country: Hungary
facility: SYNEXUS Magyarorszag Kft.
city: Budapest
country: Hungary
facility: Synexus Magyarorzag Kft.
city: Gyongyos
country: Hungary
facility: Pharma 4 Trial Kft.
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz
city: Mosonmagyarovar
country: Hungary
facility: TaNaMed Kft.
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz
city: Kaunas
country: Lithuania
facility: PI Kaunas Silainiai Outpatient Clinic
city: Kaunas
country: Lithuania
facility: Private Clinic Elite Medicale
city: Klaipeda
country: Lithuania
facility: PI Klaipeda Seamen Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Mexico
country: Mexico
facility: Clinicos Asociados BOCM, S.C.
state: Distrito Federal
city: Naucalpan
country: Mexico
facility: Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)
state: Estado DE Mexico
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Instituto de Diabetes, Obesidad y Nutricion S.C.
state: Morelos
city: Cuernavaca
country: Mexico
facility: Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca
state: Morelos
city: San Luis Potosí
country: Mexico
facility: Centro de Atención e Investigación Cardiovascular del Potosí S.C.
state: SAN LUIS Potosi
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
city: Aguascalientes
country: Mexico
facility: Centro Hospitalario Mac, S.A. De C.V. (Emergencies)
city: San Luis Potosi
country: Mexico
facility: Hospital Angeles Centro Medico del Potosi (Emergencies)
city: Craiova
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie
state: Dolj
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"
city: Cluj-Napoca
country: Romania
facility: Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice
city: Ploiesti
country: Romania
facility: Elit Medical SRL
city: Kemerovo
country: Russian Federation
facility: Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular
city: Moscow
country: Russian Federation
facility: FSAEI of Higher Education "People's Friendship University of Russia",
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"
city: Saratov
country: Russian Federation
facility: Municipal Institution of Healthcare "City Clinical Hospital 12
city: St. Petersburg
country: Russian Federation
facility: LLC "Institute of medical research"
city: Petrer
country: Spain
facility: Centro Salud Petrer I
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
state: Galicia
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid
state: Madrid
city: Reus
country: Spain
facility: Hospital Universitario Sant Joan de Reus
state: Tarragona
city: Alzira
country: Spain
facility: Hospital Universitario La Ribera
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Unidad Metabolico-Vascular
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Miguel Servet; Medicina Interna
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Reading
country: United Kingdom
facility: Synexus Thames Valley Clinical Research Centre
state: Berkshire
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Centre
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Centre
state: Lanarkshire
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
state: Lancashire
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Centre
state: Llanishen
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre
state: Merseyside
city: Antrim
country: United Kingdom
facility: Northmed Clinical Research Ltd, Randalstown Health Centre
state: Northern Ireland
city: Portadown
country: United Kingdom
facility: Southern Health & Social Care Trust, Craigavon Area Hospital
state: Northern Ireland
city: Hexham
country: United Kingdom
facility: Synexus North East Clinical Research Centre-Hexham General Hospital
state: Northumberland
city: Hexham
country: United Kingdom
facility: Synexus North East Clinical Research Centre
state: Northumberland
city: Addlestone
country: United Kingdom
facility: The Crouch Oak Family Practice
state: Surrey
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
state: WEST Midlands
city: Bradford on Avon
country: United Kingdom
facility: The Bradford on Avon & Melksham Health Partnership
state: Wiltshire
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.