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

PHASE3CompletedINTERVENTIONAL
Enrollment

2,139

Participants

Timeline

Start Date

October 29, 2013

Primary Completion Date

July 5, 2016

Study Completion Date

July 10, 2017

Conditions
Hyperlipidemia
Interventions
DRUG

Bococizumab (PF-04950615; RN316)

150 mg every 2 weeks, subcutaneous injection, 12 months

OTHER

Placebo

subcutaneous injection every 2 weeks for 12 months

Trial Locations (249)

1036

SYNEXUS Magyarorszag Kft., Budapest

Synexus Magyarorzag Kft., Budapest

3200

Pharma 4 Trial Kft., Gyöngyös

3526

Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz, Miskolc

6500

Bajai Szent Rokus Korhaz, Baja

Lausmed Kft., Baja

7623

Pecsi Tudomanyegyetem, Pécs

8230

DRC Kft., Balatonfüred

8400

Magyar Imre Korhaz, Belgyogyaszati Szakrendeles, Ajka

8900

Zala Megyei Korhaz, Zalaegerszeg

9200

TaNaMed Kft., Mosonmagyaróvár

10530

Drug Trials America, Hartsdale

11217

Taipei Veterans General Hospital, Taipei

11230

Drug Trials Brooklyn, Brooklyn

12206

Albany Medical College, Division of Community Endocrinology, Albany

12553

Mid Hudson Medical Research, PLLC, New Windsor

13088

SJH Cardiology Associates, Liverpool

15212

Allegheny Endocrinology Associates, Pittsburgh

15706

Hospital Clinico Universitario Santiago de Compostela, Santiago de Compostela

16508

Liberty Family Practice, Erie

16635

Altoona Center for Clinical Research, Duncansville

17001

Asociacion IPS Medicos InterniStas de Caldas, Manizales

18840

Guthrie Medical Group, PC, Sayre

18974

Warminster Medical Associates, P.C., Warminster

19063

Suburban Research Associates, Media

19335

Brandywine Clinical Research, Downingtown

19446

Detweiler Family Medicine and Associates, PC, Lansdale

20110

Manassas Clinical Research Center, Manassas

20230

Centenario Hospital Miguel Hidalgo, Aguascalientes

Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV, Aguascalientes

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

20745

MD Medical Research, Oxon Hill

21045

Columbia Medical Practice, Columbia

22601

Amherst Family Practice, P.C., Winchester

Selma Medical Associates, Winchester

23148

Cardinal Tien Hospital, New Taipei City

23294

National Clinical Research-Richmond, Inc., Richmond

27103

PMG Research of Winston-Salem, Winston-Salem

27408

PharmQuest, Greensboro

28046

Hospital Universitario La Paz; Unidad Metabolico-Vascular, Madrid

28117

Crossroads Clinical Research, Inc., Mooresville

28144

PMG Research of Salisbury, LLC, Salisbury

28223

Hospital Universitario Quiron Madrid, Pozuelo de Alarcón

28277

Sensenbrenner Primary Care, Charlotte

28401

PMG Research of Wilmington, LLC, Wilmington

29407

Coastal Cardiology, Charleston

29485

Palmetto Clinical Research, Summerville

29615

Upstate Pharmaceutical Research, Greenville

30075

Atlanta Center for Clinical Research / Internal Medicine, Roswell

30189

North Georgia Clinical Research, Woodstock

North Georgia Internal Medicine, Woodstock

30318

Atlanta Diabetes Associates, Atlanta

31059

CHU de Toulouse - Hopital Rangueil, Toulouse

32003

Fleming Island Center for Clinical Research, Fleming Island

32081

St. Johns Center for Clinical Research, Ponte Vedra

32205

Westside Center for Clinical Research, Jacksonville

32216

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

East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center, Jacksonville

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

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

St. Vincent's Cardiology, Jacksonville

32605

Florida Research Network, LLC, Gainesville

32720

Avail Clinical Research, LLC, DeLand

32765

Oviedo Medical Research, LLC, Oviedo

32825

Florida Institute For Clinical Research, LLC, Orlando

33012

AGA Clinical Trials, Hialeah

33013

The Research Center, Inc., Hialeah

33015

San Marcus Research Clinic, Inc., Miami

33024

A&R Research Group, LLC, Pembroke Pines

33029

DBC Research, Pembroke Pines

33030

Homestead Medical Research Inc., Homestead

33126

Clinical Research of Miami, Miami

Finlay Medical Research, Miami

33143

South Miami Clinical Research Center, LLC, South Miami

33144

Medical Research Center, Miami

33166

Dolphin Medical Research, Virginia Gardens

33183

International Research Associates, LLC, Miami

33185

Kendall South Medical Center, Miami

33308

Invesclinic, LLC, Fort Lauderdale

33401

Metabolic Research Institute Incorporated, West Palm Beach

33462

ACRC-Cardiology, Atlantis

33756

Morton Plant Mease Health Care, Inc. Cardiovascular Research, Clearwater

33880

Clinical Research of Central Florida, Winter Haven

34452

Nature Coast Clinical Research, Inverness

35233

The Kirklin Clinic, Birmingham

35235

Alabama Internal Medicine, P.C., Birmingham

35294

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

35510

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

35611

Ernest L. Hendrix, MD, PC, Athens

North Alabama Research Center, LLC, Athens

35801

Heart Center Research, Llc, Huntsville

37917

Cardiovascular Research of Knoxville, Knoxville

37920

New Orleans Center for Clinical Research, Knoxville

Volunteer Research Group, Knoxville

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

43204

Hospital Universitario Sant Joan de Reus, Reus

44200

Nouvelles Cliniques Nantaises, Nantes

44311

Radiant Research, Inc, Akron

44600

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

44614

Community Health Care, Inc., Canal Fulton

45219

Sterling Research Group, Ltd., Cincinnati

The Lindner Center for Research and Education at The Christ Hospital, Cincinnati

45227

Metabolic and Atherosclerosis Research Center, Cincinnati

45236

Sentral Clinical Research Services - Admin Only, Cincinnati

Sentral Clinical Research Services, Cincinnati

45246

Sterling Research Group, Ltd., Cincinnati

46112

Investigators Research Group, LLC, Brownsburg

46254

American Health Network, LLC, Indianapolis

46260

Midwest Institute for Clinical Research, Indianapolis

46383

Buynak Clinical Research, P.C., Valparaiso

46600

Hospital Universitario La Ribera, Alzira

48085

Oakland Medical Research Center, Troy

48118

IHA Chelsea Family & Internal Medicine, Chelsea

48334

QUEST Research Institute, Farmington Hills

49009

Westside Family Medical Center, Pc, Kalamazoo

49770

Michigan Heart and Vascular Specialists, Petoskey

50009

Hospital Clinico Universitario Miguel Servet; Medicina Interna, Zaragoza

50031

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

51501

West Broadway Clinic, Council Bluffs

52242

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

55102

HealthEast Medical Research Institute, Saint Paul

HealthEast St. Joseph's Hospital Pharmacy, Saint Paul

55435

Radiant Research, Inc., Edina

59200

Hopital Guy Chatiliez, Tourcoing

Hopital Guy Chatillez, Tourcoing

62250

Instituto de Diabetes, Obesidad y Nutricion S.C., Cuernavaca

62270

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

63090

Mercy Health Research, Washington

64106

KCUMB Center for Community and Clinical Research, Kansas City

66160

University of Kansas Medical Center, Kansas City

66215

Midwest Heart and Vascular Specialists, Overland Park

70006

Omega Clinical Research, Metairie

70119

New Orleans Center for Clinical Research, New Orleans

73072

LION Research, Norman

75093

Advanced Clinical Research Associates, Plano

75216

North Texas Healthcare System, Dallas VAMC, Dallas

75231

Research Institute of Dallas, Dallas

76012

KRK Medical Research, Arlington

76107

University of North Texas Health Science Center at Fort Worth, Fort Worth

77030

Baylor College of Medicine, Houston

lnvestigational Drug Services (IDA), Houston

77070

Northwest Houston Cardiology, Houston

77081

Texas Center for Drug Development, Inc., Houston

77099

Pioneer Research Solutions, Inc., Houston

77375

Northwest Heart Center, Tomball

78130

Hill Country Medical Associates, New Braunfels

78200

Centro de Atención e Investigación Cardiovascular del Potosí S.C., San Luis Potosí City

Hospital Angeles Centro Medico del Potosi (Emergencies), San Luis Potosí City

78215

Sun Research Institute, San Antonio

78249

Bandera Family Health Care, LLC, San Antonio

80020

Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios, Barranquilla

80904

Clinicos, LLC, Colorado Springs

80906

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

83646

Solaris Clinical Research, Meridian

83704

Northwest Clinical Trials, Inc., Boise

84123

Radiant Research, Murray

85018

Elite Clinical Studies, LLC, Phoenix

85021

Phoenix Clinical, Phoenix

85205

Arizona Center For Internal Medicine, Mesa

85224

Radiant Research Incorporated, Chandler

85308

Advanced Research Associates, Glendale

85381

Holland Center for Family Health, Peoria

85710

Desert Sun Clinical Research, LLC, Tucson

85712

Advanced Arizona Clinical Research, Tucson

86021

CHU La Miletrie, Poitiers

89119

Om Medical, Las Vegas

89121

Clinical Research of South Nevada, Las Vegas

90017

Downtown L.A. Research Center, Inc., Los Angeles

90255

Alia Clinical Research, Inc., Huntington Park

91307

Infosphere Clinical Research, INC, West Hills

91324

California Medical Research Associates Inc., Northridge

91786

Empire Clinical Research, Upland

92064

Arch Health Partners Clinical Research Department, Poway

92220

Care Clinical Research Corporation, Banning

92648

California Heart Specialists, Huntington Beach

92780

Orange County Research Center, Tustin

93065

Alta California Medical Group, Simi Valley

94598

Diablo Clinical Research, Inc., Walnut Creek

95032

Richard S. Cherlin, M.D., Los Gatos

95608

Med Center, Carmichael

95628

Med Investigations, Fair Oaks

95821

Clinical Trials Research, Sacramento

Northern California Research, Sacramento

96814

East-West Medical Research Institute, Honolulu

97504

Clinical Research Institute of Southern Oregon, PC, Medford

98057

Rainier Clinical Research Center, Renton

99352

Zain Research LLC, Richland

100018

Elit Medical SRL, Ploieşti

110221

Dexa Diab Servicios Medicos Ltda. IPS, Bogota

117292

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

130013

Centro de Diagnostico Cardiologico LTDA., Cartagena

196084

"LLC Institute of medical research", Saint Petersburg

197706

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

198205

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

200642

Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie, Craiova

400349

Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice, Cluj-Napoca

410039

"Municipal Institution of Healthcare City Clinical Hospital 12", Saratov

500283

Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna, Brasov

650002

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

760032

Centro de Investigaciones Clinicas S.A.S, Santiago de Cali

06473

YNHH, Heart and Vascular, North Haven

04005

Southern Maine Health Care, Biddeford

08901

Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School, New Brunswick

08873

Cardio Metabolic Institute, Somerset

08611

Premier Research, Trenton

V8T 5G4

Discovery Clinical Services Ltd., Victoria

N1R 7R1

Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation, Cambridge

L8L 5G8

The Office of Dr. Allen Greenspoon, Hamilton

N6A 5A5

London Health Sciences Centre, London

N6G 2V2

Stroke Prevention & Atherosclerosis Research Centre (SPARC), London

L3Y 8C3

Newmarket Cardiology Research Group, Newmarket

N7T 4X3

London Road Diagnostic Clinic and Medical Centre, Sarnia

M5C 2T2

St. Michael's Hospital Health Centre, Toronto

J2B 7T1

Rhodin Recherche Clinique, Drummondville

G6W 0M5

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

J7J 2K8

Omnispec Clinical Research Inc., Mirabel

H1T 1C8

Montreal Heart Institute, Montreal

J1H 1Z1

DIEX Research Sherbrooke Inc., Sherbrooke

050012

Rodrigo Botero S.A.S, Medellín

Unknown

BIOMELAB Ltda., Barranquilla

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

Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA, Bogota

Fundacion Cardiomet - CEQUIN, Armenia

Fundacion Cardiovascular De Colombia, Floridablanca

Fundacion Centro de Investigaciones Biomedicas RIESCARD, Espinal

LT-48259

PI Kaunas Silainiai Outpatient Clinic, Kaunas

LT-50177

Private Clinic Elite Medicale, Kaunas

LT-92288

PI Klaipeda Seamen Hospital, Klaipėda

LT-08661

Vilnius University Hospital Santariskiu Klinikos, Vilnius

03300

Clinicos Asociados BOCM, S.C., Mexico City

010825

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

03610

Centro Salud Petrer I, Petrel

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d'Hebron, Barcelona

RG2 0TG

Synexus Thames Valley Clinical Research Centre, Reading

M15 6SX

Synexus Manchester Clinical Research Centre, Manchester

G20 0SP

Synexus Scotland Clinical Research Centre, Glasgow

PR7 7NA

Synexus Lancashire Clinical Research Centre, Chorley

CF14 5GJ

Synexus Wales Clinical Research Centre, Cardiff

L22 0LG

Synexus Merseyside Clinical Research Centre, Liverpool

BT41 3AE

Northmed Clinical Research Ltd, Randalstown Health Centre, Antrim

BT63 5QQ

Southern Health & Social Care Trust, Craigavon Area Hospital, Portadown

NE46 1QJ

Synexus North East Clinical Research Centre-Hexham General Hospital, Hexham

Synexus North East Clinical Research Centre, Hexham

KT15 2BH

The Crouch Oak Family Practice, Addlestone

B15 2SQ

Synexus Midlands Clinical Research Centre, Birmingham

BA15 1DQ

The Bradford on Avon & Melksham Health Partnership, Bradford-on-Avon

DD1 9SY

Ninewells Hospital & Medical School, Dundee

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01968967 - Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events | Biotech Hunter | Biotech Hunter