Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
NCT ID: NCT02100514
Last Updated: 2018-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
746 participants
INTERVENTIONAL
2014-10-28
2017-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bococizumab (PF-04950615; RN316)
Bococizumab (PF-04950615; RN316)
Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection for 52 weeks.
placebo
Placebo
Subcutaneous injection every 2 weeks for 52 weeks.
Interventions
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Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection for 52 weeks.
Placebo
Subcutaneous injection every 2 weeks for 52 weeks.
Eligibility Criteria
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Inclusion Criteria
* Fasting LDL-C \>=100 mg/dL and triglyceride \<= 400 mg/dL
* High or very high risk of incurring a cardiovascular event
Exclusion Criteria
* Cardiovascular or cerebrovascular event or procedure within 90 days
* Congestive heart failure NYHA class IV
* Poorly controlled hypertension
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Advanced Cardiovascular, LLC Research
Alexander City, Alabama, United States
Advanced Cardiovascular, LLC, Research
Auburn, Alabama, United States
Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
Phoenix, Arizona, United States
Clinical Research Advantage, Inc./Family Practice Specialists, LTD
Phoenix, Arizona, United States
Radiant Research, Inc.
Tucson, Arizona, United States
Radiant Research, Inc
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
The Office of Larry Watkins, MD
Little Rock, Arkansas, United States
American Institute of Research
Los Angeles, California, United States
lntermed Group
Los Angeles, California, United States
IMD Medical Group
Los Angeles, California, United States
The Office of Lucita M. Cruz, M.D., Inc.
Norwalk, California, United States
Superior Research, LLC
Sacramento, California, United States
Superior Research ,LLC
Sacramento, California, United States
Radiant Research, Inc.
Santa Rosa, California, United States
Orange County Research Center
Tustin, California, United States
Ventura Clinical Trials
Ventura, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Clinical Research Advantage, Inc. / Colorado Springs Family Practice
Colorado Springs, Colorado, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
Boca Raton Clinical Research Associates
Boca Raton, Florida, United States
BRCR Medical Center, Inc.
Boca Raton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Linfritz Research Institute Inc.
Coral Gables, Florida, United States
Florida Health Center
Fort Lauderdale, Florida, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Sunrise Research Institute, Inc
Miami, Florida, United States
Prestige Clinical Research Center, Inc.
Miami, Florida, United States
Suncoast Research Group, LLD
Miami, Florida, United States
Elite Clinical Research
Miami, Florida, United States
Advanced Clinical Research of Miami
Miami, Florida, United States
The Research Specialists of Florida, Inc.
Miami, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Precision Research Organization
Miami Lakes, Florida, United States
First Quality
Miramar, Florida, United States
American Family Medical
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Andres Patron, D.O.P.A.
Pembroke Pines, Florida, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Accord Clinical Research, Llc
Port Orange, Florida, United States
East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
Saint Augustine, Florida, United States
East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
Saint Augustine, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Meridien Research
Tampa, Florida, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, United States
American Health Network of Indiana, LLC
Avon, Indiana, United States
Heartland Research Associates, LLC
Augusta, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Northwest Family Physicians
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Imperial Health, LLP
Lake Charles, Louisiana, United States
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, United States
Clinical Trials of America LA
Monroe, Louisiana, United States
Bethesda Health Research
Bethesda, Maryland, United States
Centennial Medical Group
Elkridge, Maryland, United States
McLaren Flint
Flint, Michigan, United States
CentraCare Heart & Vascular Center @ St. Cloud Hospital
Saint Cloud, Minnesota, United States
CentraCare Heart & Vascular Center at St. Cloud Hospital
Saint Cloud, Minnesota, United States
Riser Medical Research
Picayune, Mississippi, United States
Washington University, The Center for Advanced Medicine
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
Fremont, Nebraska, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Physician's East Endocrinology
Greenville, North Carolina, United States
Physician's East P.A.
Greenville, North Carolina, United States
Physician's East, PA
Greenville, North Carolina, United States
Catawba Valley Medical Group, Inc.
Hickory, North Carolina, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, United States
PMG Research of Hickory
Hickory, North Carolina, United States
Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Primed Clinical Research
Dayton, Ohio, United States
Office of Daniel G. Williams, MD
Perrysburg, Ohio, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States
Castlerock Clinical Research Consultants,LLC
Tulsa, Oklahoma, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, United States
Medical Research South, LLC
Charleston, South Carolina, United States
Ellipsis Research Group, LLC
Columbia, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, United States
Apex Cardiology
Jackson, Tennessee, United States
Research Associates of Jackson
Jackson, Tennessee, United States
PMG Research, Inc d/b/a PMG Research of Knoxville
Knoxville, Tennessee, United States
Punzi Medical Center
Carrollton, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Gulf Coast Medical Research,LLC
Houston, Texas, United States
Office of Michelle Zaniewski MD., PA.
Houston, Texas, United States
Juno Research, LLC
Katy, Texas, United States
Gulf Coast Medical Research, LLC
Missouri City, Texas, United States
Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
Plano, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Gulf Coast Medical Research, LLC
Sugar Land, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Millennium Clinical Trials, LLC
Arlington, Virginia, United States
National Clinical Research-Norfolk, Inc.
Norfolk, Virginia, United States
Sound Health Care Center
Port Orchard, Washington, United States
Sound Medical Research
Port Orchard, Washington, United States
Walla Walla Clinic
Walla Walla, Washington, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
HFM Heart and Vascular Center/Holy Family Memorial, Inc
Manitowoc, Wisconsin, United States
LMC Clinical Research Inc. (Calgary)
Calgary, Alberta, Canada
Office of Dr. Ronald Collette MD
Burnaby, British Columbia, Canada
Medical Arts Health Research Group
Kamloops, British Columbia, Canada
The Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Glover Medical Clinic
Langley, British Columbia, Canada
Fraser Clinical Trials
New Westminster, British Columbia, Canada
The Medical Arts Health Research Group
Penticton, British Columbia, Canada
The Office of James K. Lai, MD Inc.
Vancouver, British Columbia, Canada
Cook Street Medical Clinic
Victoria, British Columbia, Canada
LMC Clinical Research Inc. (Barrie)
Barrie, Ontario, Canada
LMC Clinical Research Inc. (Brampton)
Brampton, Ontario, Canada
Aggarwal And Associates Ltd
Brampton, Ontario, Canada
Corunna Medical Research Centre
Corunna, Ontario, Canada
LMC Clinical Research Inc. (Etobicoke)
Etobicoke, Ontario, Canada
LMC Clinical Research Inc. (Markham)
Markham, Ontario, Canada
SKDS Research Inc.
Newmarket, Ontario, Canada
LMC Clinical Research Inc. (Oakville)
Oakville, Ontario, Canada
The Office of Dr. James Cha
Oshawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada
Scarborough Cardiology Research
Scarborough Village, Ontario, Canada
LMC Clinical Research Inc. (Thornhill)
Thornhill, Ontario, Canada
Rouge Valley Health System - Centenary
Toronto, Ontario, Canada
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, Canada
Manna Research Inc.
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
ViaCar Recherche Clinique Inc.
Greenfield Park, Quebec, Canada
Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud
Longueuil, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Clinique des maladies lipidiques de Quebec
Québec, Quebec, Canada
Alpha Recherche Clinique
Québec, Quebec, Canada
Centre De Sante Et De Services Sociaux De Beauce (CSSSB)
Saint-Georges, Beauce, Quebec, Canada
C.I.C. Maurice Inc.
Trois-Rivières, Quebec, Canada
C.I.C. Mauricie Inc.
Trois-Rivières, Quebec, Canada
Kardiologicka ambulance
Trutnov, Královéhradecký kraj, Czechia
Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
Prague, Vinohrady, Czechia
Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
Brno, , Czechia
Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
Brno, , Czechia
Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
Kladno, , Czechia
Lekarna - P-P Klinika Kladno
Kladno, , Czechia
Lunacor s.r.o.
Kroměříž, , Czechia
Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
Olomouc, , Czechia
Lekarna Fakultni nemocnice Olomouc (pharmacy)
Olomouc, , Czechia
Lekarna Domovina
Olomouc, , Czechia
PreventaMed, s.r.o.
Olomouc, , Czechia
IKEM, Oddeleni preventivni kardiologie
Prague, , Czechia
IKEM, Ustavni lekarna
Prague, , Czechia
BENU lekarna
Příbram, , Czechia
Kardiologicka ambulance, III. Poliklinika
Příbram, , Czechia
Lekarna 203-02
Slaný, , Czechia
Nemocnice Slany, Interni oddeleni
Slaný, , Czechia
AeskuLab k.s., Lipidova poradna
Teplice, , Czechia
Lekarna Centrum (pharmacy)
Teplice, , Czechia
Dr.Max lekarna
Trutnov, , Czechia
Etela-Karjalan Keskussairaala
Lappeenranta, , Finland
Turku University Hospital
Turku, , Finland
Medisch Spectrum Twente
Enschede, ER, Netherlands
St Lucas Andreas Hospital
Amsterdam, North Holland, Netherlands
Gelre Hospitals
Apeldoorn, , Netherlands
Andromed Eindhoven
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Beatrix Hospital
Gorinchem, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Andro Medical Research B.V.
Rotterdam, , Netherlands
Ikazia Hospital
Rotterdam, , Netherlands
D&A Research and Genetics
Sneek, , Netherlands
St. Elisabeth Hospital
Tilburg, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Ossum Gronert Legetjeneste AS
Hønefoss, , Norway
Oslo Universitetssykehus HF
Oslo, , Norway
Oslo Universitetssykehus HF, Ulleval
Oslo, , Norway
KO-MED Centra Kliniczne Lublin
Lublin, Lublin Voivodeship, Poland
KO-MED Centra Kliniczne Zamosc
Zamość, Lublin Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, , Poland
MCBK Sc lwona Czajkowska Monika Barney
Grodzisk Mazowiecki, , Poland
Synexus Polska Sp. z o. o. Oddizial w Katowicach.
Katowice, , Poland
Clinport Tura Lipinska Dabrowski S.C.
Katowice, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Jan Zbigniew Peruga NZOZ SALUS
Lodz, , Poland
Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych
Oława, , Poland
Synexus Polska Sp. z o.o Oddzial w Poznaniu
Poznan, , Poland
KO-MED Centra Kliniczne Sp. z o.o.
Puławy, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, , Poland
.WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina
Wroclaw, , Poland
KO-MED. Centra Kliniczne Staszow
Staszów, Świętokrzyskie Voivodeship, Poland
Ponce School Of Medicine
Ponce, PR, Puerto Rico
Cardiometabolic Research Center, Inc
Ponce, PR, Puerto Rico
Caparra Internal Medicine
Río Grande, , Puerto Rico
National University Hospital
Singapore, , Singapore
National Heart Centre Singapore
Singapore, , Singapore
Sacred Heart Hospital-Hallym University
Anyang-si, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Clinical Trial Center (CTC)/Centrum foer klinisk proevning
Gothenburg, , Sweden
Vardcentralen Lessebo
Lessebo, , Sweden
Clinical Trials Consultants AB
Linköping, , Sweden
ProbarE i Lund AB
Lund, , Sweden
Capio Citykliniken Hjartmottagning
Lund, , Sweden
Dalecarlia Clinical Research Center
Rättvik, , Sweden
Citydiabetes
Stockholm, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Synexus Thames Valley Clinical Research Centre
Reading, Berkshire, United Kingdom
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, Lanarkshire Scotland, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, United Kingdom
Synexus North East Clinical Research Centre - Hexham General Hospital
Hexham, Northumberland, United Kingdom
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester, Worcestershire, United Kingdom
University Hospital Ayr - Nhs Ayrshire And Arran
Ayr, , United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham, , United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, , United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool, , United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, , United Kingdom
Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,
Swansea, , United Kingdom
Countries
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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.
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.
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.
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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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SPIRE-LL
Identifier Type: OTHER
Identifier Source: secondary_id
2014-000478-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1481045
Identifier Type: -
Identifier Source: org_study_id
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