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

PHASE3CompletedINTERVENTIONAL
Enrollment

746

Participants

Timeline

Start Date

October 28, 2014

Primary Completion Date

July 15, 2016

Study Completion Date

July 10, 2017

Conditions
Hyperlipidemia
Interventions
DRUG

Bococizumab (PF-04950615; RN316)

150 mg every 2 weeks, subcutaneous injection for 52 weeks.

OTHER

Placebo

Subcutaneous injection every 2 weeks for 52 weeks.

Trial Locations (223)

3515

Ossum Gronert Legetjeneste AS, Hønefoss

7513

Medisch Spectrum Twente, Enschede

11923

Hanyang University Guri Hospital, Guri-si

19438

Harleysville Medical Associates, Harleysville

19610

Berks Cardiologists, Ltd., Wyomissing

20520

Turku University Hospital, Turku

21075

Centennial Medical Group, Elkridge

22207

Millennium Clinical Trials, LLC, Arlington

22221

Capio Citykliniken Hjartmottagning, Lund

23502

National Clinical Research-Norfolk, Inc., Norfolk

27280

Cardiocentrum Kladno s.r.o., Kardiologicka ambulance, Kladno

Lekarna - P-P Klinika Kladno, Kladno

27612

Wake Internal Medicine Consultants, Inc., Raleigh

Wake Research Associates, LLC, Raleigh

27834

Physician's East Endocrinology, Greenville

Physician's East P.A., Greenville

Physician's East, PA, Greenville

28601

Catawba Valley Medical Group, Inc., Hickory

Clinical Trials of America, Inc., Hickory

28602

PMG Research of Hickory, Hickory

29204

Ellipsis Research Group, LLC, Columbia

29303

Spartanburg Medical Research, Spartanburg

29407

Medical Research South, LLC, Charleston

32086

East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute, Saint Augustine

East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research, Saint Augustine

32127

Progressive Medical Research, Port Orange

32129

Accord Clinical Research, Llc, Port Orange

33012

Health Care Family Rehab & Research Center, Hialeah

Indago Research & Health Center, Inc., Hialeah

33014

Panax Clinical Research, Miami Lakes

33016

Precision Research Organization, Miami Lakes

33025

First Quality, Miramar

33026

Andres Patron, D.O.P.A., Pembroke Pines

Pines Care Research Center, LLC, Pembroke Pines

33029

DBC Research USA, Pembroke Pines

33130

Sunrise Research Institute, Inc, Miami

33133

Prestige Clinical Research Center, Inc., Miami

33134

Linfritz Research Institute Inc., Coral Gables

33135

Suncoast Research Group, LLD, Miami

33140

NewPhase Clinical Trials, Corp., Miami Beach

33144

Elite Clinical Research, Miami

33155

Advanced Clinical Research of Miami, Miami

33162

The Research Specialists of Florida, Inc., Miami

33165

Columbus Clinical Services, LLC, Miami

33312

Florida Health Center, Fort Lauderdale

33432

Boca Raton Clinical Research Associates, Boca Raton

BRCR Medical Center, Inc., Boca Raton

33634

Meridien Research, Tampa

33709

Meridien Research, St. Petersburg

34239

Cardiovascular Center of Sarasota, Sarasota

34471

American Family Medical, Ocala

Renstar Medical Research, Ocala

34601

Meridien Research, Brooksville

35010

Advanced Cardiovascular, LLC Research, Alexander City

36830

Advanced Cardiovascular, LLC, Research, Auburn

37912

PMG Research, Inc d/b/a PMG Research of Knoxville, Knoxville

38138

Stern Cardiovascular Foundation, Inc, Germantown

38301

Apex Cardiology, Jackson

Research Associates of Jackson, Jackson

39466

Riser Medical Research, Picayune

43551

Office of Daniel G. Williams, MD, Perrysburg

45419

Primed Clinical Research, Dayton

46123

American Health Network of Indiana, LLC, Avon

48532

McLaren Flint, Flint

49201

Dong-A University Hospital, Busan

53130

Etela-Karjalan Keskussairaala, Lappeenranta

53142

Clinical Investigation Specialists, Inc., Kenosha

54101

Kardiologicka ambulance, Trutnov

54220

HFM Heart and Vascular Center/Holy Family Memorial, Inc, Manitowoc

56303

CentraCare Heart & Vascular Center @ St. Cloud Hospital, Saint Cloud

CentraCare Heart & Vascular Center at St. Cloud Hospital, Saint Cloud

58758

Clinical Trials Consultants AB, Linköping

63110

Washington University, The Center for Advanced Medicine, St Louis

67010

Heartland Research Associates, LLC, Augusta

67205

Heartland Research Associates, LLC, Wichita

Northwest Family Physicians, Wichita

67207

Heartland Research Associates, LLC, Wichita

68025

Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC), Fremont

70006

Crescent City Clinical Research Center, LLC, Metairie

70601

Imperial Health, LLP, Lake Charles

71201

Clinical Trials of America LA, Monroe

72205

Lynn Institute of the Ozarks, Little Rock

The Office of Larry Watkins, MD, Little Rock

73135

South Oklahoma Heart Research, LLC, Oklahoma City

74136

Castlerock Clinical Research Consultants,LLC, Tulsa

75006

Punzi Medical Center, Carrollton

75093

Clinical Research Advantage, Inc./ Plano Internal Medicine Associates, Plano

76701

Lunacor s.r.o., Kroměříž

77036

Juno Research, LLC, Houston

77081

Gulf Coast Medical Research,LLC, Houston

77090

Office of Michelle Zaniewski MD., PA., Houston

77450

Juno Research, LLC, Katy

77459

Gulf Coast Medical Research, LLC, Missouri City

77478

Gulf Coast Medical Research, LLC, Sugar Land

77520

Lekarna Fakultni nemocnice Olomouc (pharmacy), Olomouc

78205

Clinical Trials of Texas, Inc., San Antonio

79530

Dalecarlia Clinical Research Center, Rättvik

80045

University of Colorado Hospital, Aurora

80209

Creekside Endocrine Associates, PC, Denver

80909

Clinical Research Advantage, Inc. / Colorado Springs Family Practice, Colorado Springs

83704

Northwest Clinical Trials, Inc., Boise

84058

Aspen Clinical Research, Orem

85018

Clinical Research Advantage, Inc./Family Practice Specialists, Ltd., Phoenix

Clinical Research Advantage, Inc./Family Practice Specialists, LTD, Phoenix

85712

Radiant Research, Inc., Tucson

Radiant Research, Inc, Tucson

87102

Albuquerque Clinical Trials, Inc., Albuquerque

90017

American Institute of Research, Los Angeles

lntermed Group, Los Angeles

90020

IMD Medical Group, Los Angeles

90650

The Office of Lucita M. Cruz, M.D., Inc., Norwalk

92780

Orange County Research Center, Tustin

93003

Ventura Clinical Trials, Ventura

95405

Radiant Research, Inc., Santa Rosa

95825

Superior Research, LLC, Sacramento

95831

Superior Research ,LLC, Sacramento

98366

Sound Health Care Center, Port Orchard

Sound Medical Research, Port Orchard

99362

Walla Walla Clinic, Walla Walla

119228

National University Hospital, Singapore

169609

National Heart Centre Singapore, Singapore

208174

Bethesda Health Research, Bethesda

Unknown

Washington University School of Medicine, St Louis

03801

ActivMed Practices & Research, Inc., Portsmouth

T2H 2G4

LMC Clinical Research Inc. (Calgary), Calgary

V5G 1T4

Office of Dr. Ronald Collette MD, Burnaby

V2C 1K7

Medical Arts Health Research Group, Kamloops

V1Y 1V6

The Medical Arts Health Research Group, Kelowna

V3A 4H9

Glover Medical Clinic, Langley

V3L 3W4

Fraser Clinical Trials, New Westminster

V2A 5C8

The Medical Arts Health Research Group, Penticton

V5Z 1K3

The Office of James K. Lai, MD Inc., Vancouver

V8V 4A1

Cook Street Medical Clinic, Victoria

L4M 7G1

LMC Clinical Research Inc. (Barrie), Barrie

L6S 0C9

LMC Clinical Research Inc. (Brampton), Brampton

L6T 0G1

Aggarwal And Associates Ltd, Brampton

N0N 1G0

Corunna Medical Research Centre, Corunna

M9R 4E1

LMC Clinical Research Inc. (Etobicoke), Etobicoke

L6B 0P9

LMC Clinical Research Inc. (Markham), Markham

L3Y 5G8

SKDS Research Inc., Newmarket

L6M 1M1

LMC Clinical Research Inc. (Oakville), Oakville

L1J 2K1

The Office of Dr. James Cha, Oshawa

K9J 0B2

Kawartha Cardiology Clinical Trials, Peterborough

M1E 5E9

Scarborough Cardiology Research, Scarborough Village

L4J 8L7

LMC Clinical Research Inc. (Thornhill), Thornhill

M1E 4B9

Rouge Valley Health System - Centenary, Toronto

M4G 3E8

LMC Clinical Research Inc. (Bayview), Toronto

M9W 4L6

Manna Research Inc., Toronto

G7H 7K9

Ecogene-21, Chicoutimi

J4V 2G8

ViaCar Recherche Clinique Inc., Greenfield Park

J4M2X1

Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud, Longueuil

H1T 1C8

Montreal Heart Institute, Montreal

G1V 4W2

Clinique des maladies lipidiques de Quebec, Québec

G3K 2P8

Alpha Recherche Clinique, Québec

G5Y 4T8

Centre De Sante Et De Services Sociaux De Beauce (CSSSB), Saint-Georges, Beauce

G8T 7A1

C.I.C. Maurice Inc., Trois-Rivières

C.I.C. Mauricie Inc., Trois-Rivières

100 34

Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika, Prague

656 91

Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie, Brno

Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy), Brno

775 20

Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka, Olomouc

779 00

Lekarna Domovina, Olomouc

PreventaMed, s.r.o., Olomouc

140 21

IKEM, Oddeleni preventivni kardiologie, Prague

IKEM, Ustavni lekarna, Prague

261 01

BENU lekarna, Příbram

Kardiologicka ambulance, III. Poliklinika, Příbram

274 01

Lekarna 203-02, Slaný

Nemocnice Slany, Interni oddeleni, Slaný

415 01

AeskuLab k.s., Lipidova poradna, Teplice

Lekarna Centrum (pharmacy), Teplice

541 01

Dr.Max lekarna, Trutnov

1061 AE

St Lucas Andreas Hospital, Amsterdam

7334 DZ

Gelre Hospitals, Apeldoorn

5611 NV

Andromed Eindhoven, Eindhoven

7513 ER

Medisch Spectrum Twente, Enschede

4204 AA

Beatrix Hospital, Gorinchem

9728 NT

Martini Ziekenhuis, Groningen

6419 PC

Zuyderland Medisch Centrum, Heerlen

3021 HC

Andro Medical Research B.V., Rotterdam

3083AN

Ikazia Hospital, Rotterdam

8601 ZR

D&A Research and Genetics, Sneek

5022 GC

St. Elisabeth Hospital, Tilburg

3584 CX

University Medical Center Utrecht, Utrecht

0373

Oslo Universitetssykehus HF, Oslo

0424

Oslo Universitetssykehus HF, Ulleval, Oslo

20-362

KO-MED Centra Kliniczne Lublin, Lublin

22-400

KO-MED Centra Kliniczne Zamosc, Zamość

81-384

Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

05-825

MCBK Sc lwona Czajkowska Monika Barney, Grodzisk Mazowiecki

40-040

Synexus Polska Sp. z o. o. Oddizial w Katowicach., Katowice

40-084

Clinport Tura Lipinska Dabrowski S.C., Katowice

31-202

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow

91-302

Jan Zbigniew Peruga NZOZ SALUS, Lodz

55-200

Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych, Oława

60-702

Synexus Polska Sp. z o.o Oddzial w Poznaniu, Poznan

24-100

KO-MED Centra Kliniczne Sp. z o.o., Puławy

01-192

Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warsaw

50-088

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw

51-685

.WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina, Wroclaw

28-200

KO-MED. Centra Kliniczne Staszow, Staszów

00716

Ponce School Of Medicine, Ponce

00717

Cardiometabolic Research Center, Inc, Ponce

00745

Caparra Internal Medicine, Río Grande

431-796

Sacred Heart Hospital-Hallym University, Anyang-si

137-701

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

413 45

Clinical Trial Center (CTC)/Centrum foer klinisk proevning, Gothenburg

360 50

Vardcentralen Lessebo, Lessebo

222 22

ProbarE i Lund AB, Lund

111 57

Citydiabetes, Stockholm

141 86

Karolinska Universitetssjukhuset Huddinge, Stockholm

RG2 0TG

Synexus Thames Valley Clinical Research Centre, Reading

M6 8HD

Salford Royal NHS Foundation Trust, Salford

G20 0SP

Synexus Scotland Clinical Research Centre, Glasgow

PR7 7NA

Synexus Lancashire Clinical Research Centre, Chorley

NE46 1QJ

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

WR5 1DD

Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital, Worcester

KA6 6DX

University Hospital Ayr - Nhs Ayrshire And Arran, Ayr

B15 2SQ

Synexus Midlands Clinical Research Centre, Birmingham

HU3 2JZ

Hull and East Yorkshire Hospitals NHS Trust, Hull

L22 0LG

Synexus Merseyside Clinical Research Centre, Liverpool

M15 6SX

Synexus Manchester Clinical Research Centre, Manchester

SA2 8PP

Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02100514 - Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events | Biotech Hunter | Biotech Hunter