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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-29

Study Completion Date

2017-07-10

Brief Summary

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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

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bococizumab (PF-04950615; RN316)

Group Type EXPERIMENTAL

Bococizumab (PF-04950615; RN316)

Intervention Type DRUG

150 mg every 2 weeks, subcutaneous injection, 12 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Intervention Type DRUG

Placebo

subcutaneous injection every 2 weeks for 12 months

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

North Alabama Research Center, LLC

Athens, Alabama, United States

Site Status

The Kirklin Clinic

Birmingham, Alabama, United States

Site Status

Alabama Internal Medicine, P.C.

Birmingham, Alabama, United States

Site Status

Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Heart Center Research, Llc

Huntsville, Alabama, United States

Site Status

Radiant Research Incorporated

Chandler, Arizona, United States

Site Status

Advanced Research Associates

Glendale, Arizona, United States

Site Status

Arizona Center For Internal Medicine

Mesa, Arizona, United States

Site Status

Holland Center for Family Health

Peoria, Arizona, United States

Site Status

Elite Clinical Studies, LLC

Phoenix, Arizona, United States

Site Status

Phoenix Clinical

Phoenix, Arizona, United States

Site Status

Desert Sun Clinical Research, LLC

Tucson, Arizona, United States

Site Status

Advanced Arizona Clinical Research

Tucson, Arizona, United States

Site Status

Care Clinical Research Corporation

Banning, California, United States

Site Status

Med Center

Carmichael, California, United States

Site Status

Med Investigations

Fair Oaks, California, United States

Site Status

California Heart Specialists

Huntington Beach, California, United States

Site Status

Alia Clinical Research, Inc.

Huntington Park, California, United States

Site Status

Downtown L.A. Research Center, Inc.

Los Angeles, California, United States

Site Status

Richard S. Cherlin, M.D.

Los Gatos, California, United States

Site Status

California Medical Research Associates Inc.

Northridge, California, United States

Site Status

Arch Health Partners Clinical Research Department

Poway, California, United States

Site Status

Clinical Trials Research

Sacramento, California, United States

Site Status

Northern California Research

Sacramento, California, United States

Site Status

Alta California Medical Group

Simi Valley, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Empire Clinical Research

Upland, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Infosphere Clinical Research, INC

West Hills, California, United States

Site Status

Clinicos, LLC

Colorado Springs, Colorado, United States

Site Status

Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW

Colorado Springs, Colorado, United States

Site Status

YNHH, Heart and Vascular

North Haven, Connecticut, United States

Site Status

ACRC-Cardiology

Atlantis, Florida, United States

Site Status

Morton Plant Mease Health Care, Inc. Cardiovascular Research

Clearwater, Florida, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

Fleming Island Center for Clinical Research

Fleming Island, Florida, United States

Site Status

Invesclinic, LLC

Fort Lauderdale, Florida, United States

Site Status

Florida Research Network, LLC

Gainesville, Florida, United States

Site Status

AGA Clinical Trials

Hialeah, Florida, United States

Site Status

The Research Center, Inc.

Hialeah, Florida, United States

Site Status

Homestead Medical Research Inc.

Homestead, Florida, United States

Site Status

Nature Coast Clinical Research

Inverness, Florida, United States

Site Status

Westside Center for Clinical Research

Jacksonville, Florida, United States

Site Status

East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA

Jacksonville, Florida, United States

Site Status

East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center

Jacksonville, Florida, United States

Site Status

East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic

Jacksonville, Florida, United States

Site Status

East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates

Jacksonville, Florida, United States

Site Status

St. Vincent's Cardiology

Jacksonville, Florida, United States

Site Status

San Marcus Research Clinic, Inc.

Miami, Florida, United States

Site Status

Clinical Research of Miami

Miami, Florida, United States

Site Status

Finlay Medical Research

Miami, Florida, United States

Site Status

Medical Research Center

Miami, Florida, United States

Site Status

International Research Associates, LLC

Miami, Florida, United States

Site Status

Kendall South Medical Center

Miami, Florida, United States

Site Status

Florida Institute For Clinical Research, LLC

Orlando, Florida, United States

Site Status

Oviedo Medical Research, LLC

Oviedo, Florida, United States

Site Status

A&R Research Group, LLC

Pembroke Pines, Florida, United States

Site Status

DBC Research

Pembroke Pines, Florida, United States

Site Status

St. Johns Center for Clinical Research

Ponte Vedra, Florida, United States

Site Status

South Miami Clinical Research Center, LLC

South Miami, Florida, United States

Site Status

Dolphin Medical Research

Virginia Gardens, Florida, United States

Site Status

Metabolic Research Institute Incorporated

West Palm Beach, Florida, United States

Site Status

Clinical Research of Central Florida

Winter Haven, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Atlanta Center for Clinical Research / Internal Medicine

Roswell, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

North Georgia Internal Medicine

Woodstock, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Northwest Clinical Trials, Inc.

Boise, Idaho, United States

Site Status

Solaris Clinical Research

Meridian, Idaho, United States

Site Status

Investigators Research Group, LLC

Brownsburg, Indiana, United States

Site Status

American Health Network, LLC

Indianapolis, Indiana, United States

Site Status

Midwest Institute for Clinical Research

Indianapolis, Indiana, United States

Site Status

Buynak Clinical Research, P.C.

Valparaiso, Indiana, United States

Site Status

West Broadway Clinic

Council Bluffs, Iowa, United States

Site Status

The University of Iowa - College of Public Health - Preventive Intervention Center

Iowa City, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Midwest Heart and Vascular Specialists

Overland Park, Kansas, United States

Site Status

Omega Clinical Research

Metairie, Louisiana, United States

Site Status

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Site Status

Southern Maine Health Care

Biddeford, Maine, United States

Site Status

Columbia Medical Practice

Columbia, Maryland, United States

Site Status

MD Medical Research

Oxon Hill, Maryland, United States

Site Status

IHA Chelsea Family & Internal Medicine

Chelsea, Michigan, United States

Site Status

QUEST Research Institute

Farmington Hills, Michigan, United States

Site Status

Westside Family Medical Center, Pc

Kalamazoo, Michigan, United States

Site Status

Michigan Heart and Vascular Specialists

Petoskey, Michigan, United States

Site Status

Oakland Medical Research Center

Troy, Michigan, United States

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Radiant Research, Inc.

Edina, Minnesota, United States

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HealthEast Medical Research Institute

Saint Paul, Minnesota, United States

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HealthEast St. Joseph's Hospital Pharmacy

Saint Paul, Minnesota, United States

Site Status

KCUMB Center for Community and Clinical Research

Kansas City, Missouri, United States

Site Status

Mercy Health Research

Washington, Missouri, United States

Site Status

Om Medical

Las Vegas, Nevada, United States

Site Status

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Site Status

Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Cardio Metabolic Institute

Somerset, New Jersey, United States

Site Status

Premier Research

Trenton, New Jersey, United States

Site Status

Albany Medical College, Division of Community Endocrinology

Albany, New York, United States

Site Status

Drug Trials Brooklyn

Brooklyn, New York, United States

Site Status

Drug Trials America

Hartsdale, New York, United States

Site Status

SJH Cardiology Associates

Liverpool, New York, United States

Site Status

Mid Hudson Medical Research, PLLC

New Windsor, New York, United States

Site Status

Sensenbrenner Primary Care

Charlotte, North Carolina, United States

Site Status

PharmQuest

Greensboro, North Carolina, United States

Site Status

Crossroads Clinical Research, Inc.

Mooresville, North Carolina, United States

Site Status

PMG Research of Salisbury, LLC

Salisbury, North Carolina, United States

Site Status

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Site Status

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

Radiant Research, Inc

Akron, Ohio, United States

Site Status

Community Health Care, Inc.

Canal Fulton, Ohio, United States

Site Status

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Site Status

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, United States

Site Status

Metabolic and Atherosclerosis Research Center

Cincinnati, Ohio, United States

Site Status

Sentral Clinical Research Services - Admin Only

Cincinnati, Ohio, United States

Site Status

Sentral Clinical Research Services

Cincinnati, Ohio, United States

Site Status

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Site Status

LION Research

Norman, Oklahoma, United States

Site Status

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Site Status

Brandywine Clinical Research

Downingtown, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Liberty Family Practice

Erie, Pennsylvania, United States

Site Status

Detweiler Family Medicine and Associates, PC

Lansdale, Pennsylvania, United States

Site Status

Suburban Research Associates

Media, Pennsylvania, United States

Site Status

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, United States

Site Status

Guthrie Medical Group, PC

Sayre, Pennsylvania, United States

Site Status

Warminster Medical Associates, P.C.

Warminster, Pennsylvania, United States

Site Status

Coastal Cardiology

Charleston, South Carolina, United States

Site Status

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Site Status

Palmetto Clinical Research

Summerville, South Carolina, United States

Site Status

Cardiovascular Research of Knoxville

Knoxville, Tennessee, United States

Site Status

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

Site Status

Volunteer Research Group

Knoxville, Tennessee, United States

Site Status

KRK Medical Research

Arlington, Texas, United States

Site Status

North Texas Healthcare System, Dallas VAMC

Dallas, Texas, United States

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Research Institute of Dallas

Dallas, Texas, United States

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University of North Texas Health Science Center at Fort Worth

Fort Worth, Texas, United States

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Baylor College of Medicine

Houston, Texas, United States

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lnvestigational Drug Services (IDA)

Houston, Texas, United States

Site Status

Northwest Houston Cardiology

Houston, Texas, United States

Site Status

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Site Status

Pioneer Research Solutions, Inc.

Houston, Texas, United States

Site Status

Hill Country Medical Associates

New Braunfels, Texas, United States

Site Status

Advanced Clinical Research Associates

Plano, Texas, United States

Site Status

Sun Research Institute

San Antonio, Texas, United States

Site Status

Bandera Family Health Care, LLC

San Antonio, Texas, United States

Site Status

Northwest Heart Center

Tomball, Texas, United States

Site Status

Radiant Research

Murray, Utah, United States

Site Status

Manassas Clinical Research Center

Manassas, Virginia, United States

Site Status

National Clinical Research-Richmond, Inc.

Richmond, Virginia, United States

Site Status

Amherst Family Practice, P.C.

Winchester, Virginia, United States

Site Status

Selma Medical Associates

Winchester, Virginia, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

Zain Research LLC

Richland, Washington, United States

Site Status

Discovery Clinical Services Ltd.

Victoria, British Columbia, Canada

Site Status

Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation

Cambridge, Ontario, Canada

Site Status

The Office of Dr. Allen Greenspoon

Hamilton, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Stroke Prevention & Atherosclerosis Research Centre (SPARC)

London, Ontario, Canada

Site Status

Newmarket Cardiology Research Group

Newmarket, Ontario, Canada

Site Status

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Site Status

St. Michael's Hospital Health Centre

Toronto, Ontario, Canada

Site Status

Rhodin Recherche Clinique

Drummondville, Quebec, Canada

Site Status

LMC Research Inc. d.b.a. Manna Research Inc.

Lévis, Quebec, Canada

Site Status

Omnispec Clinical Research Inc.

Mirabel, Quebec, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

DIEX Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Site Status

Rodrigo Botero S.A.S

Medellín, Antioquia, Colombia

Site Status

Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.

Medellín, Antioquia, Colombia

Site Status

Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios

Barranquilla, Atlántico, Colombia

Site Status

BIOMELAB Ltda.

Barranquilla, Atlántico, Colombia

Site Status

IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.

Barranquilla, Atlántico, Colombia

Site Status

Asociacion IPS Medicos InterniStas de Caldas

Manizales, Caldas Department, Colombia

Site Status

Dexa Diab Servicios Medicos Ltda. IPS

Bogota, Cundinamarca, Colombia

Site Status

Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA

Bogota, Cundinamarca, Colombia

Site Status

Centro de Diagnostico Cardiologico LTDA.

Cartagena, Departamento de Bolívar, Colombia

Site Status

Fundacion Cardiomet - CEQUIN

Armenia, Quindío Department, Colombia

Site Status

Fundacion Cardiovascular De Colombia

Floridablanca, Santander Department, Colombia

Site Status

Fundacion Centro de Investigaciones Biomedicas RIESCARD

Espinal, Tolima Department, Colombia

Site Status

Centro de Investigaciones Clinicas S.A.S

Cali, Valle del Cauca Department, Colombia

Site Status

Nouvelles Cliniques Nantaises

Nantes, , France

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CHU La Miletrie

Poitiers, , France

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CHU de Toulouse - Hopital Rangueil

Toulouse, , France

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Hopital Guy Chatiliez

Tourcoing, , France

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Hopital Guy Chatillez

Tourcoing, , France

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Magyar Imre Korhaz, Belgyogyaszati Szakrendeles

Ajka, , Hungary

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Bajai Szent Rokus Korhaz

Baja, , Hungary

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Lausmed Kft.

Baja, , Hungary

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DRC Kft.

Balatonfüred, , Hungary

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SYNEXUS Magyarorszag Kft.

Budapest, , Hungary

Site Status

Synexus Magyarorzag Kft.

Budapest, , Hungary

Site Status

Pharma 4 Trial Kft.

Gyöngyös, , Hungary

Site Status

Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz

Miskolc, , Hungary

Site Status

TaNaMed Kft.

Mosonmagyaróvár, , Hungary

Site Status

Pecsi Tudomanyegyetem

Pécs, , Hungary

Site Status

Zala Megyei Korhaz

Zalaegerszeg, , Hungary

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PI Kaunas Silainiai Outpatient Clinic

Kaunas, , Lithuania

Site Status

Private Clinic Elite Medicale

Kaunas, , Lithuania

Site Status

PI Klaipeda Seamen Hospital

Klaipėda, , Lithuania

Site Status

Vilnius University Hospital Santariskiu Klinikos

Vilnius, , Lithuania

Site Status

Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.

Guadalajara, Jalisco, Mexico

Site Status

Clinicos Asociados BOCM, S.C.

Mexico City, Mexico City, Mexico

Site Status

Instituto de Diabetes, Obesidad y Nutricion S.C.

Cuernavaca, Morelos, Mexico

Site Status

Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca

Cuernavaca, Morelos, Mexico

Site Status

Centro de Atención e Investigación Cardiovascular del Potosí S.C.

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)

Naucalpan, State of Mexico, Mexico

Site Status

Centenario Hospital Miguel Hidalgo

Aguascalientes, , Mexico

Site Status

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

Aguascalientes, , Mexico

Site Status

Centro Hospitalario Mac, S.A. De C.V. (Emergencies)

Aguascalientes, , Mexico

Site Status

Hospital Angeles Centro Medico del Potosi (Emergencies)

San Luis Potosí City, , Mexico

Site Status

Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie

Craiova, Dolj, Romania

Site Status

Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna

Brasov, , Romania

Site Status

Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"

Bucharest, , Romania

Site Status

Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice

Cluj-Napoca, , Romania

Site Status

Elit Medical SRL

Ploieşti, , Romania

Site Status

Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular

Kemerovo, , Russia

Site Status

FSAEI of Higher Education "People's Friendship University of Russia",

Moscow, , Russia

Site Status

LLC "Institute of medical research"

Saint Petersburg, , Russia

Site Status

Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi

Saint Petersburg, , Russia

Site Status

Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"

Saint Petersburg, , Russia

Site Status

Municipal Institution of Healthcare "City Clinical Hospital 12

Saratov, , Russia

Site Status

Centro Salud Petrer I

Petrel, Alicante, Spain

Site Status

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, Galicia, Spain

Site Status

Hospital Universitario Quiron Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status

Hospital Universitario Sant Joan de Reus

Reus, Tarragona, Spain

Site Status

Hospital Universitario La Ribera

Alzira, Valencia, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario La Paz; Unidad Metabolico-Vascular

Madrid, , Spain

Site Status

Hospital Clinico Universitario Miguel Servet; Medicina Interna

Zaragoza, , Spain

Site Status

Cardinal Tien Hospital

New Taipei City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Synexus Thames Valley Clinical Research Centre

Reading, Berkshire, United Kingdom

Site Status

Synexus Manchester Clinical Research Centre

Manchester, Greater Manchester, United Kingdom

Site Status

Synexus Scotland Clinical Research Centre

Glasgow, Lanarkshire, United Kingdom

Site Status

Synexus Lancashire Clinical Research Centre

Chorley, Lancashire, United Kingdom

Site Status

Synexus Wales Clinical Research Centre

Cardiff, Llanishen, United Kingdom

Site Status

Synexus Merseyside Clinical Research Centre

Liverpool, Merseyside, United Kingdom

Site Status

Northmed Clinical Research Ltd, Randalstown Health Centre

Antrim, Northern Ireland, United Kingdom

Site Status

Southern Health & Social Care Trust, Craigavon Area Hospital

Portadown, Northern Ireland, United Kingdom

Site Status

Synexus North East Clinical Research Centre-Hexham General Hospital

Hexham, Northumberland, United Kingdom

Site Status

Synexus North East Clinical Research Centre

Hexham, Northumberland, United Kingdom

Site Status

The Crouch Oak Family Practice

Addlestone, Surrey, United Kingdom

Site Status

Synexus Midlands Clinical Research Centre

Birmingham, WEST Midlands, United Kingdom

Site Status

The Bradford on Avon & Melksham Health Partnership

Bradford-on-Avon, Wiltshire, United Kingdom

Site Status

Ninewells Hospital & Medical School

Dundee, , United Kingdom

Site Status

Countries

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United States Canada Colombia France Hungary Lithuania Mexico Romania Russia Spain Taiwan United Kingdom

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.

Reference Type DERIVED
PMID: 37994400 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37658997 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35277540 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29685591 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28304227 (View on PubMed)

Related Links

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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