Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Last updated: April 6, 2017
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Hypercholesterolemia

Dyslipidemia

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT01968954
B1481019
2013-002642-37
SPIRE-HR
  • Ages > 18
  • All Genders

Study 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

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

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 Design

Total Participants: 711
Study Start date:
October 01, 2013
Estimated Completion Date:
April 30, 2016

Connect with a study center

  • Australian Clinical Research Network

    Maroubra, New South Wales 2035
    Australia

    Site Not Available

  • Core Research Group Pty Ltd

    Milton, Queensland 4064
    Australia

    Site Not Available

  • Dorevitch Pathology

    St Kilda East, Victoria 3183
    Australia

    Site Not Available

  • The Avenue Cardiovascular Centre

    St. Kilda East, Victoria 3183
    Australia

    Site Not Available

  • Thunder Bay Regional Research Institute

    Thunder Bay, Ontario P7B 7C7
    Canada

    Site Not Available

  • Ecogene-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • Diex Research Montreal Inc.

    Montreal, Quebec H4N 3C5
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • ALPHA Recherche Clinique

    Quebec City, Quebec G3K 2P8
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Medexa Recherche

    Victoriaville, Quebec G6P 6P6
    Canada

    Site Not Available

  • Clinique des maladies lipidiques de Quebec Inc.

    Quebec, G1V 4M6
    Canada

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czech Republic

    Site Not Available

  • Kardiologicka ambulance

    Ostrava, 702 00
    Czech Republic

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czech Republic

    Site Not Available

  • Kardiologie a interni lekarstvi

    Praha 5, 158 00
    Czech Republic

    Site Not Available

  • Lekarsky dum Ormiga

    Zlin, 760 01
    Czech Republic

    Site Not Available

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117
    Germany

    Site Not Available

  • Klinische Forschung Hannover - Mitte GmbH

    Hannover, 30159
    Germany

    Site Not Available

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063
    Germany

    Site Not Available

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055
    Germany

    Site Not Available

  • The Chinese University of Hong Kong

    Shatin,
    Hong Kong

    Site Not Available

  • Department of Medicine & Therapeutics-The Chinese University of Hong Kong

    Shatin, NT,
    Hong Kong

    Site Not Available

  • IRCCS Centro Cardiologico Fondazione Monzino

    Milano, MI 20138
    Italy

    Site Not Available

  • IRCCS Istituto Auxologico Italiano

    Milano, MI 20145
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milano, MI 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

    Palermo, PA 90127
    Italy

    Site Not Available

  • Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I

    Roma, RM 00161
    Italy

    Site Not Available

  • CRC room

    Dongku, Gwangju 501-757
    Korea, Republic of

    Site Not Available

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

    Bucheon-si, Gyeonggi-do 420-717
    Korea, Republic of

    Site Not Available

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

    Uijeongbu-si, Gyeonggi-do 480-717
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon, 301-721
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-Do, 220-701
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 501-757
    Korea, Republic of

    Site Not Available

  • Gangnam Sevrance Hospital, Yeonsei University Health System

    Seoul, 135-720
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

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

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 443-380
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan, 682-714
    Korea, Republic of

    Site Not Available

  • SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, Mazowieckie 40-040
    Poland

    Site Not Available

  • NZOZ Terapia Optima

    Katowice, Slaskie 40-752
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-384
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.

    Lodz, 92-003
    Poland

    Site Not Available

  • Medicus w Opolu Sp z o.o.

    Opole, 45-706
    Poland

    Site Not Available

  • Medicome Sp. z o.o.

    Oswiecim, 32-600
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o Oddzial w Poznaniu

    Poznan, 60-702
    Poland

    Site Not Available

  • Centrum Medyczne Ogrodowa Sp. z o.o.

    Skierniewice, 96-100
    Poland

    Site Not Available

  • Centrum Medyczne "SOPMED" Sp. z o.o.

    Sopot, 81-756
    Poland

    Site Not Available

  • Centrum Medyczne "SOPMED" Sp. z o.o. Niepubliczny Zakld Opieki Zdrowotnej

    Sopot pomorskie, 81-756
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 01192
    Poland

    Site Not Available

  • CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego

    Warszawa, 02-507
    Poland

    Site Not Available

  • Centrum Medyczne AMED

    Warszawa, 01-518
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warszawa, 01-192
    Poland

    Site Not Available

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, 50-088
    Poland

    Site Not Available

  • Achieve Clinical Research, LLC

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Cardiovascular Associates of the Southeast, LLC

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • (Administrative Mailing Only) Clinical Research Advantage, Inc./Cassidy Medical Group - Vista

    Tempe, Arizona 85282
    United States

    Site Not Available

  • ARA-Arizona Research Associates

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Southwest Heart Group

    Tucson, Arizona 85710
    United States

    Site Not Available

  • Diagnamics, Inc.

    Encinitas, California 92024
    United States

    Site Not Available

  • Encompass Clinical Research North Coast

    Encinitas, California 92024
    United States

    Site Not Available

  • MD Studies, Inc.

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Alliance Research Centers

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Prime Care Clinical Research

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Providence Clinical Research

    North Hollywood, California 91606
    United States

    Site Not Available

  • San Diego Family Care

    San Diego, California 92111
    United States

    Site Not Available

  • St. Joseph's Medical Associates

    Stockton, California 95204
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Clinical Research Advantage, Inc./Cassidy Medical Group - Vista

    Vista, California 92083
    United States

    Site Not Available

  • Elite Clinical Trials

    Wildomar, California 92595
    United States

    Site Not Available

  • Expresscare Clinical Research

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Soundview Medical Associates

    Norwalk, Connecticut 06851
    United States

    Site Not Available

  • Eastern Research, Inc.

    Hialeah, Florida 33013
    United States

    Site Not Available

  • Care Partners Clinical Research, LLC

    Jacksonville, Florida 32277
    United States

    Site Not Available

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

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Prestige Clinical Research Center Inc

    Miami, Florida 33133
    United States

    Site Not Available

  • Edgewater Medical Research

    New Smyrna Beach, Florida 32169
    United States

    Site Not Available

  • Gulfcoast Medical Research Center, LLC

    Tampa, Florida 33607
    United States

    Site Not Available

  • Fellows Research Alliance, Inc.

    Savannah, Georgia 31406
    United States

    Site Not Available

  • SouthCoast Medical Group

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Evanston Premier Healthcare Research LLC

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Comunity Clinical Research Center

    Anderson, Indiana 46011
    United States

    Site Not Available

  • American Health Network of Indiana, LLC

    Avon, Indiana 46123
    United States

    Site Not Available

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Horizon Research Group of Opelousas, LLC

    Eunice, Louisiana 70535
    United States

    Site Not Available

  • Internal Medicine Associates

    Eunice, Louisiana 70535
    United States

    Site Not Available

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • Allina Health System, dba Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • University of MN, Lillehei Clinical Trials Unit

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Montana Medical Research Inc.

    Missoula, Montana 59808
    United States

    Site Not Available

  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Clinical Trials of America, Inc.

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Radiant Research, Inc

    Akron, Ohio 44311
    United States

    Site Not Available

  • Rapid Medical Research, Inc.

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • The Office of Daniel G. Williams, MD

    Perrysburg, Ohio 43551
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Willoughby, Ohio 44094
    United States

    Site Not Available

  • South Oklahoma Heart Research LLC

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Integrated Medical Research, PC

    Ashland, Oregon 97520
    United States

    Site Not Available

  • Columbia Research Group, Inc.

    Portland, Oregon 97239
    United States

    Site Not Available

  • Harleysville Medical Associates

    Harleysville, Pennsylvania 19438
    United States

    Site Not Available

  • The Heart Group of Lancaster General Health

    Lancaster, Pennsylvania 17603
    United States

    Site Not Available

  • Perelman Center for Advanced Medicine Heart & Vascular Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Medical Research South,LLC

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Berkeley Family Practice

    Moncks Corner, South Carolina 29461
    United States

    Site Not Available

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • 3 rd Coast Research Associates

    Corpus Christi, Texas 78413
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc.

    Houston, Texas 77099
    United States

    Site Not Available

  • Texas Center For Drug Development, Inc.

    Houston, Texas 77081
    United States

    Site Not Available

  • Protenium Clinical Research

    Hurst, Texas 76054
    United States

    Site Not Available

  • Lone Peak Family Medicine

    Draper, Utah 84020
    United States

    Site Not Available

  • Utah Cardiology, P.C.

    Layton, Utah 84041
    United States

    Site Not Available

  • National Clinical Research - Norfolk, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Premier Clinical Research

    Spokane, Washington 99202
    United States

    Site Not Available

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