Clinical trial NCT02100514: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Official title: A 52 Week Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: Primary hyperlipidemia or mixed dyslipidemia
high risk of cardiovascular events
multiple cardiovascular disease risk factors.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.


Eligibility criteria: Inclusion Criteria:

* Treated with a statin
* Fasting LDL-C \>=100 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 or procedure within 90 days
* Congestive heart failure NYHA class IV
* Poorly controlled hypertension

Primary outcomes:
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period
timeFrame: Baseline, Week 24, 52
measure: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
timeFrame: Baseline, Week 12, 24, 52
measure: Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
timeFrame: Week 12, 24, 52
measure: Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
timeFrame: Week 12, 24, 52
measure: Plasma Concentration Versus Time Summary of PF-04950615
timeFrame: Week 12, 24, 52
measure: Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions
timeFrame: Baseline up to end of study (up to 110 weeks)
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
timeFrame: Baseline up to Week 58
measure: Number of Participants Who Changed Concomitant Medication During Extension Period
timeFrame: Week 58 follow-up to Week 110
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period
timeFrame: Baseline, Week 58 (follow up), 71, 84, 97, 110
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
timeFrame: Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Advanced Cardiovascular, LLC Research
state: Alabama
city: Auburn
country: United States
facility: Advanced Cardiovascular, LLC, Research
state: Alabama
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc./Family Practice Specialists, LTD
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: The Office of Larry Watkins, MD
state: Arkansas
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Los Angeles
country: United States
facility: lntermed Group
state: California
city: Los Angeles
country: United States
facility: IMD Medical Group
state: California
city: Norwalk
country: United States
facility: The Office of Lucita M. Cruz, M.D., Inc.
state: California
city: Sacramento
country: United States
facility: Superior Research, LLC
state: California
city: Sacramento
country: United States
facility: Superior Research ,LLC
state: California
city: Santa Rosa
country: United States
facility: Radiant Research, Inc.
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Advantage, Inc. / Colorado Springs Family Practice
state: Colorado
city: Denver
country: United States
facility: Creekside Endocrine Associates, PC
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Clinical Research Associates
state: Florida
city: Boca Raton
country: United States
facility: BRCR Medical Center, Inc.
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Coral Gables
country: United States
facility: Linfritz Research Institute Inc.
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Health Center
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab & Research Center
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Miami Beach
country: United States
facility: NewPhase Clinical Trials, Corp.
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Precision Research Organization
state: Florida
city: Miami
country: United States
facility: Sunrise Research Institute, Inc
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLD
state: Florida
city: Miami
country: United States
facility: Elite Clinical Research
state: Florida
city: Miami
country: United States
facility: Advanced Clinical Research of Miami
state: Florida
city: Miami
country: United States
facility: The Research Specialists of Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC
state: Florida
city: Miramar
country: United States
facility: First Quality
state: Florida
city: Ocala
country: United States
facility: American Family Medical
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, D.O.P.A.
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research USA
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, Llc
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Boise
country: United States
facility: Northwest Clinical Trials, Inc.
state: Idaho
city: Avon
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Northwest Family Physicians
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lake Charles
country: United States
facility: Imperial Health, LLP
state: Louisiana
city: Metairie
country: United States
facility: Crescent City Clinical Research Center, LLC
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America LA
state: Louisiana
city: Bethesda
country: United States
facility: Bethesda Health Research
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Flint
country: United States
facility: McLaren Flint
state: Michigan
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center @ St. Cloud Hospital
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Heart & Vascular Center at St. Cloud Hospital
state: Minnesota
city: Picayune
country: United States
facility: Riser Medical Research
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University, The Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Fremont
country: United States
facility: Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
state: Nebraska
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Greenville
country: United States
facility: Physician's East Endocrinology
state: North Carolina
city: Greenville
country: United States
facility: Physician's East P.A.
state: North Carolina
city: Greenville
country: United States
facility: Physician's East, PA
state: North Carolina
city: Hickory
country: United States
facility: Catawba Valley Medical Group, Inc.
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Dayton
country: United States
facility: Primed Clinical Research
state: Ohio
city: Perrysburg
country: United States
facility: Office of Daniel G. Williams, MD
state: Ohio
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Castlerock Clinical Research Consultants,LLC
state: Oklahoma
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, Ltd.
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Columbia
country: United States
facility: Ellipsis Research Group, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation, Inc
state: Tennessee
city: Jackson
country: United States
facility: Apex Cardiology
state: Tennessee
city: Jackson
country: United States
facility: Research Associates of Jackson
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research, Inc d/b/a PMG Research of Knoxville
state: Tennessee
city: Carrollton
country: United States
facility: Punzi Medical Center
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Houston
country: United States
facility: Gulf Coast Medical Research,LLC
state: Texas
city: Houston
country: United States
facility: Office of Michelle Zaniewski MD., PA.
state: Texas
city: Katy
country: United States
facility: Juno Research, LLC
state: Texas
city: Missouri City
country: United States
facility: Gulf Coast Medical Research, LLC
state: Texas
city: Plano
country: United States
facility: Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Sugar Land
country: United States
facility: Gulf Coast Medical Research, LLC
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Arlington
country: United States
facility: Millennium Clinical Trials, LLC
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research-Norfolk, Inc.
state: Virginia
city: Port Orchard
country: United States
facility: Sound Health Care Center
state: Washington
city: Port Orchard
country: United States
facility: Sound Medical Research
state: Washington
city: Walla Walla
country: United States
facility: Walla Walla Clinic
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
city: Manitowoc
country: United States
facility: HFM Heart and Vascular Center/Holy Family Memorial, Inc
state: Wisconsin
city: Calgary
country: Canada
facility: LMC Clinical Research Inc. (Calgary)
state: Alberta
city: Burnaby
country: Canada
facility: Office of Dr. Ronald Collette MD
state: British Columbia
city: Kamloops
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Kelowna
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Langley
country: Canada
facility: Glover Medical Clinic
state: British Columbia
city: New Westminster
country: Canada
facility: Fraser Clinical Trials
state: British Columbia
city: Penticton
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Vancouver
country: Canada
facility: The Office of James K. Lai, MD Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Cook Street Medical Clinic
state: British Columbia
city: Barrie
country: Canada
facility: LMC Clinical Research Inc. (Barrie)
state: Ontario
city: Brampton
country: Canada
facility: LMC Clinical Research Inc. (Brampton)
state: Ontario
city: Brampton
country: Canada
facility: Aggarwal And Associates Ltd
state: Ontario
city: Corunna
country: Canada
facility: Corunna Medical Research Centre
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Clinical Research Inc. (Etobicoke)
state: Ontario
city: Markham
country: Canada
facility: LMC Clinical Research Inc. (Markham)
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: LMC Clinical Research Inc. (Oakville)
state: Ontario
city: Oshawa
country: Canada
facility: The Office of Dr. James Cha
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Cardiology Clinical Trials
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Cardiology Research
state: Ontario
city: Thornhill
country: Canada
facility: LMC Clinical Research Inc. (Thornhill)
state: Ontario
city: Toronto
country: Canada
facility: Rouge Valley Health System - Centenary
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research Inc. (Bayview)
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Inc.
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Greenfield Park
country: Canada
facility: ViaCar Recherche Clinique Inc.
state: Quebec
city: Longueuil
country: Canada
facility: Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Saint-Georges, Beauce
country: Canada
facility: Centre De Sante Et De Services Sociaux De Beauce (CSSSB)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: C.I.C. Maurice Inc.
state: Quebec
city: Trois-Rivieres
country: Canada
facility: C.I.C. Mauricie Inc.
state: Quebec
city: Quebec
country: Canada
facility: Clinique des maladies lipidiques de Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Trutnov
country: Czechia
facility: Kardiologicka ambulance
state: Kralovehradecky KRAJ
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
state: Vinohrady
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
city: Kladno
country: Czechia
facility: Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
city: Kladno
country: Czechia
facility: Lekarna - P-P Klinika Kladno
city: Kromeriz
country: Czechia
facility: Lunacor s.r.o.
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
city: Olomouc
country: Czechia
facility: Lekarna Fakultni nemocnice Olomouc (pharmacy)
city: Olomouc
country: Czechia
facility: Lekarna Domovina
city: Olomouc
country: Czechia
facility: PreventaMed, s.r.o.
city: Praha 4
country: Czechia
facility: IKEM, Oddeleni preventivni kardiologie
city: Praha 4
country: Czechia
facility: IKEM, Ustavni lekarna
city: Pribram
country: Czechia
facility: BENU lekarna
city: Pribram
country: Czechia
facility: Kardiologicka ambulance, III. Poliklinika
city: Slany
country: Czechia
facility: Lekarna 203-02
city: Slany
country: Czechia
facility: Nemocnice Slany, Interni oddeleni
city: Teplice
country: Czechia
facility: AeskuLab k.s., Lipidova poradna
city: Teplice
country: Czechia
facility: Lekarna Centrum (pharmacy)
city: Trutnov
country: Czechia
facility: Dr.Max lekarna
city: Lappeenranta
country: Finland
facility: Etela-Karjalan Keskussairaala
city: Turku
country: Finland
facility: Turku University Hospital
city: Anyang-si
country: Korea, Republic of
facility: Sacred Heart Hospital-Hallym University
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: ER
city: Amsterdam
country: Netherlands
facility: St Lucas Andreas Hospital
state: North Holland
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
city: Eindhoven
country: Netherlands
facility: Andromed Eindhoven
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Gorinchem
country: Netherlands
facility: Beatrix Hospital
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Andro Medical Research B.V.
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
city: Sneek
country: Netherlands
facility: D&A Research and Genetics
city: Tilburg
country: Netherlands
facility: St. Elisabeth Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Honefoss
country: Norway
facility: Ossum Gronert Legetjeneste AS
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Ulleval
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin
state: Lubelskie
city: Zamosc
country: Poland
facility: KO-MED Centra Kliniczne Zamosc
state: Lubelskie
city: Staszow
country: Poland
facility: KO-MED. Centra Kliniczne Staszow
state: Swietokrzyskie
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Grodzisk Mazowiecki
country: Poland
facility: MCBK Sc lwona Czajkowska Monika Barney
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o. o. Oddizial w Katowicach.
city: Katowice
country: Poland
facility: Clinport Tura Lipinska Dabrowski S.C.
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Lodz
country: Poland
facility: Jan Zbigniew Peruga NZOZ SALUS
city: Olawa
country: Poland
facility: Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o Oddzial w Poznaniu
city: Pulawy
country: Poland
facility: KO-MED Centra Kliniczne Sp. z o.o.
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Wroclaw
country: Poland
facility: .WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina
city: Ponce
country: Puerto Rico
facility: Ponce School Of Medicine
city: Ponce
country: Puerto Rico
facility: Cardiometabolic Research Center, Inc
city: Rio Grande
country: Puerto Rico
facility: Caparra Internal Medicine
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Goteborg
country: Sweden
facility: Clinical Trial Center (CTC)/Centrum foer klinisk proevning
city: Lessebo
country: Sweden
facility: Vardcentralen Lessebo
city: Linkoping
country: Sweden
facility: Clinical Trials Consultants AB
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Lund
country: Sweden
facility: Capio Citykliniken Hjartmottagning
city: Rattvik
country: Sweden
facility: Dalecarlia Clinical Research Center
city: Stockholm
country: Sweden
facility: Citydiabetes
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Reading
country: United Kingdom
facility: Synexus Thames Valley Clinical Research Centre
state: Berkshire
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Centre
state: Lanarkshire Scotland
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
state: Lancashire
city: Hexham
country: United Kingdom
facility: Synexus North East Clinical Research Centre - Hexham General Hospital
state: Northumberland
city: Worcester
country: United Kingdom
facility: Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
state: Worcestershire
city: Ayr
country: United Kingdom
facility: University Hospital Ayr - Nhs Ayrshire And Arran
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Centre
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.