AzTrials
AzTrials

HyperlipidemiaPhase 3SPIRE-LDLNCT01968967

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

A Phase 3 study testing Bococizumab (PF-04950615; RN316) in people with Hyperlipidemia, run by Pfizer at 249 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperlipidemia
What is being tested?
Bococizumab (PF-04950615; RN316)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,139 participants
Where
249 sitesin 12 countries
Study dates
29 Oct 2013to 10 Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnant or breastfeeding females.
  • Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • Congestive heart failure NYHA class IV.
  • Poorly controlled hypertension.

Trial locations and contacts

249 sites in 12 countries.

249 sites in 12 countries

United States155 sites

  • Radiant Research, Inc

    Akron, Ohio, 44311

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York, 12206

  • KRK Medical Research

    Arlington, Texas, 76012

  • Ernest L. Hendrix, MD, PC

    Athens, Alabama, 35611

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • ACRC-Cardiology

    Atlantis, Florida, 33462

  • Care Clinical Research Corporation

    Banning, California, 92220

  • Southern Maine Health Care

    Biddeford, Maine, 04005

  • The Kirklin Clinic

    Birmingham, Alabama, 35233

  • Alabama Internal Medicine, P.C.

    Birmingham, Alabama, 35235

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

    Birmingham, Alabama, 35294

  • Northwest Clinical Trials, Inc.

    Boise, Idaho, 83704

  • Drug Trials Brooklyn

    Brooklyn, New York, 11230

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Community Health Care, Inc.

    Canal Fulton, Ohio, 44614

  • Med Center

    Carmichael, California, 95608

  • Radiant Research Incorporated

    Chandler, Arizona, 85224

  • Coastal Cardiology

    Charleston, South Carolina, 29407

  • Sensenbrenner Primary Care

    Charlotte, North Carolina, 28277

  • IHA Chelsea Family & Internal Medicine

    Chelsea, Michigan, 48118

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio, 45219

  • The Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio, 45219

  • Metabolic and Atherosclerosis Research Center

    Cincinnati, Ohio, 45227

  • Sentral Clinical Research Services - Admin Only

    Cincinnati, Ohio, 45236

  • Sentral Clinical Research Services

    Cincinnati, Ohio, 45236

  • Sterling Research Group, Ltd.

    Cincinnati, Ohio, 45246

  • Morton Plant Mease Health Care, Inc. Cardiovascular Research

    Clearwater, Florida, 33756

  • Clinicos, LLC

    Colorado Springs, Colorado, 80904

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

    Colorado Springs, Colorado, 80906

  • Columbia Medical Practice

    Columbia, Maryland, 21045

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • North Texas Healthcare System, Dallas VAMC

    Dallas, Texas, 75216

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Brandywine Clinical Research

    Downingtown, Pennsylvania, 19335

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Radiant Research, Inc.

    Edina, Minnesota, 55435

  • Liberty Family Practice

    Erie, Pennsylvania, 16508

  • Med Investigations

    Fair Oaks, California, 95628

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Invesclinic, LLC

    Fort Lauderdale, Florida, 33308

  • University of North Texas Health Science Center at Fort Worth

    Fort Worth, Texas, 76107

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • Advanced Research Associates

    Glendale, Arizona, 85308

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Drug Trials America

    Hartsdale, New York, 10530

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • The Research Center, Inc.

    Hialeah, Florida, 33013

  • Homestead Medical Research Inc.

    Homestead, Florida, 33030

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Baylor College of Medicine

    Houston, Texas, 77030

  • lnvestigational Drug Services (IDA)

    Houston, Texas, 77030

  • Northwest Houston Cardiology

    Houston, Texas, 77070

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099

  • California Heart Specialists

    Huntington Beach, California, 92648

  • Alia Clinical Research, Inc.

    Huntington Park, California, 90255

  • Heart Center Research, Llc

    Huntsville, Alabama, 35801

  • American Health Network, LLC

    Indianapolis, Indiana, 46254

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • The University of Iowa - College of Public Health - Preventive Intervention Center

    Iowa City, Iowa, 52242

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

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

    Jacksonville, Florida, 32216

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

    Jacksonville, Florida, 32216

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

    Jacksonville, Florida, 32216

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

    Jacksonville, Florida, 32216

  • St. Vincent's Cardiology

    Jacksonville, Florida, 32216

  • Westside Family Medical Center, Pc

    Kalamazoo, Michigan, 49009

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • KCUMB Center for Community and Clinical Research

    Kansas City, Missouri, 64106

  • Cardiovascular Research of Knoxville

    Knoxville, Tennessee, 37917

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Detweiler Family Medicine and Associates, PC

    Lansdale, Pennsylvania, 19446

  • Om Medical

    Las Vegas, Nevada, 89119

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California, 90017

  • Richard S. Cherlin, M.D.

    Los Gatos, California, 95032

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Arizona Center For Internal Medicine

    Mesa, Arizona, 85205

  • Omega Clinical Research

    Metairie, Louisiana, 70006

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33015

  • Clinical Research of Miami

    Miami, Florida, 33126

  • Finlay Medical Research

    Miami, Florida, 33126

  • Medical Research Center

    Miami, Florida, 33144

  • International Research Associates, LLC

    Miami, Florida, 33183

  • Kendall South Medical Center

    Miami, Florida, 33185

  • Crossroads Clinical Research, Inc.

    Mooresville, North Carolina, 28117

  • Radiant Research

    Murray, Utah, 84123

  • Hill Country Medical Associates

    New Braunfels, Texas, 78130

  • Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York, 12553

  • LION Research

    Norman, Oklahoma, 73072

  • YNHH, Heart and Vascular

    North Haven, Connecticut, 06473

  • California Medical Research Associates Inc.

    Northridge, California, 91324

  • Florida Institute For Clinical Research, LLC

    Orlando, Florida, 32825

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66215

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • A&R Research Group, LLC

    Pembroke Pines, Florida, 33024

  • DBC Research

    Pembroke Pines, Florida, 33029

  • Holland Center for Family Health

    Peoria, Arizona, 85381

  • Michigan Heart and Vascular Specialists

    Petoskey, Michigan, 49770

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Phoenix Clinical

    Phoenix, Arizona, 85021

  • Allegheny Endocrinology Associates

    Pittsburgh, Pennsylvania, 15212

  • Advanced Clinical Research Associates

    Plano, Texas, 75093

  • St. Johns Center for Clinical Research

    Ponte Vedra, Florida, 32081

  • Arch Health Partners Clinical Research Department

    Poway, California, 92064

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Zain Research LLC

    Richland, Washington, 99352

  • National Clinical Research-Richmond, Inc.

    Richmond, Virginia, 23294

  • Atlanta Center for Clinical Research / Internal Medicine

    Roswell, Georgia, 30075

  • Clinical Trials Research

    Sacramento, California, 95821

  • Northern California Research

    Sacramento, California, 95821

  • HealthEast Medical Research Institute

    Saint Paul, Minnesota, 55102

  • HealthEast St. Joseph's Hospital Pharmacy

    Saint Paul, Minnesota, 55102

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Bandera Family Health Care, LLC

    San Antonio, Texas, 78249

  • Guthrie Medical Group, PC

    Sayre, Pennsylvania, 18840

  • Alta California Medical Group

    Simi Valley, California, 93065

  • Cardio Metabolic Institute

    Somerset, New Jersey, 08873

  • South Miami Clinical Research Center, LLC

    South Miami, Florida, 33143

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Northwest Heart Center

    Tomball, Texas, 77375

  • Premier Research

    Trenton, New Jersey, 08611

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Desert Sun Clinical Research, LLC

    Tucson, Arizona, 85710

  • Advanced Arizona Clinical Research

    Tucson, Arizona, 85712

  • Orange County Research Center

    Tustin, California, 92780

  • Empire Clinical Research

    Upland, California, 91786

  • Buynak Clinical Research, P.C.

    Valparaiso, Indiana, 46383

  • Dolphin Medical Research

    Virginia Gardens, Florida, 33166

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Warminster Medical Associates, P.C.

    Warminster, Pennsylvania, 18974

  • Mercy Health Research

    Washington, Missouri, 63090

  • Infosphere Clinical Research, INC

    West Hills, California, 91307

  • Metabolic Research Institute Incorporated

    West Palm Beach, Florida, 33401

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Amherst Family Practice, P.C.

    Winchester, Virginia, 22601

  • Selma Medical Associates

    Winchester, Virginia, 22601

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • North Georgia Internal Medicine

    Woodstock, Georgia, 30189

Other trials in United States

United Kingdom14 sites

  • The Crouch Oak Family Practice

    Addlestone, Surrey, KT15 2BH

  • Northmed Clinical Research Ltd, Randalstown Health Centre

    Antrim, Northern Ireland, BT41 3AE

  • Synexus Midlands Clinical Research Centre

    Birmingham, WEST Midlands, B15 2SQ

  • The Bradford on Avon & Melksham Health Partnership

    Bradford on Avon, Wiltshire, BA15 1DQ

  • Synexus Wales Clinical Research Centre

    Cardiff, Llanishen, CF14 5GJ

  • Synexus Lancashire Clinical Research Centre

    Chorley, Lancashire, PR7 7NA

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

  • Synexus Scotland Clinical Research Centre

    Glasgow, Lanarkshire, G20 0SP

  • Synexus North East Clinical Research Centre-Hexham General Hospital

    Hexham, Northumberland, NE46 1QJ

  • Synexus North East Clinical Research Centre

    Hexham, Northumberland, NE46 1QJ

  • Synexus Merseyside Clinical Research Centre

    Liverpool, Merseyside, L22 0LG

  • Synexus Manchester Clinical Research Centre

    Manchester, Greater Manchester, M15 6SX

  • Southern Health & Social Care Trust, Craigavon Area Hospital

    Portadown, Northern Ireland, BT63 5QQ

  • Synexus Thames Valley Clinical Research Centre

    Reading, Berkshire, RG2 0TG

Other trials in United Kingdom

Canada13 sites

  • Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation

    Cambridge, Ontario, N1R 7R1

  • Rhodin Recherche Clinique

    Drummondville, Quebec, J2B 7T1

  • The Office of Dr. Allen Greenspoon

    Hamilton, Ontario, L8L 5G8

  • LMC Research Inc. d.b.a. Manna Research Inc.

    Lévis, Quebec, G6W 0M5

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Stroke Prevention & Atherosclerosis Research Centre (SPARC)

    London, Ontario, N6G 2V2

  • Omnispec Clinical Research Inc.

    Mirabel, Quebec, J7J 2K8

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Newmarket Cardiology Research Group

    Newmarket, Ontario, L3Y 8C3

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario, N7T 4X3

  • DIEX Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • St. Michael's Hospital Health Centre

    Toronto, Ontario, M5C 2T2

  • Discovery Clinical Services Ltd.

    Victoria, British Columbia, V8T 5G4

Other trials in Canada

Colombia13 sites

  • Fundacion Cardiomet - CEQUIN

    Armenia, Quindío Department

  • Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios

    Barranquilla, Atlántico, 80020

  • BIOMELAB Ltda.

    Barranquilla, Atlántico

  • IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.

    Barranquilla, Atlántico

  • Dexa Diab Servicios Medicos Ltda. IPS

    Bogota, Cundinamarca, 110221

  • Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA

    Bogota, Cundinamarca

  • Centro de Investigaciones Clinicas S.A.S

    Cali, Valle del Cauca Department, 760032

  • Centro de Diagnostico Cardiologico LTDA.

    Cartagena, Departamento de Bolívar, 130013

  • Fundacion Centro de Investigaciones Biomedicas RIESCARD

    Espinal, Tolima Department

  • Fundacion Cardiovascular De Colombia

    Floridablanca, Santander Department

  • Asociacion IPS Medicos InterniStas de Caldas

    Manizales, Caldas Department, 17001

  • Rodrigo Botero S.A.S

    Medellín, Antioquia, 050012

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

    Medellín, Antioquia, 50031

Other trials in Colombia

Hungary11 sites

  • Magyar Imre Korhaz, Belgyogyaszati Szakrendeles

    Ajka, 8400

  • Bajai Szent Rokus Korhaz

    Baja, 6500

  • Lausmed Kft.

    Baja, 6500

  • DRC Kft.

    Balatonfüred, 8230

  • SYNEXUS Magyarorszag Kft.

    Budapest, 1036

  • Synexus Magyarorzag Kft.

    Budapest, 1036

  • Pharma 4 Trial Kft.

    Gyöngyös, 3200

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

    Miskolc, 3526

  • TaNaMed Kft.

    Mosonmagyaróvár, 9200

  • Pecsi Tudomanyegyetem

    Pécs, 7623

  • Zala Megyei Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Mexico10 sites

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20230

  • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

    Aguascalientes, 20230

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

    Aguascalientes, 20230

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

    Cuernavaca, Morelos, 62250

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

    Cuernavaca, Morelos, 62270

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

    Guadalajara, Jalisco, 44600

  • Clinicos Asociados BOCM, S.C.

    Mexico City, Mexico City, 03300

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

    Naucalpan, State of Mexico, 35510

  • Centro de Atención e Investigación Cardiovascular del Potosí S.C.

    San Luis Potosí City, San Luis Potosí, 78200

  • Hospital Angeles Centro Medico del Potosi (Emergencies)

    San Luis Potosí City, 78200

Other trials in Mexico

Spain9 sites

  • Hospital Universitario La Ribera

    Alzira, Valencia, 46600

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario La Paz; Unidad Metabolico-Vascular

    Madrid, 28046

  • Centro Salud Petrer I

    Petrel, Alicante, 03610

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Sant Joan de Reus

    Reus, Tarragona, 43204

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, Galicia, 15706

  • Hospital Clinico Universitario Miguel Servet; Medicina Interna

    Zaragoza, 50009

Other trials in Spain

Russia6 sites

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

    Kemerovo, 650002

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

    Moscow, 117292

  • LLC "Institute of medical research"

    Saint Petersburg, 196084

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

    Saint Petersburg, 197706

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

    Saint Petersburg, 198205

  • Municipal Institution of Healthcare "City Clinical Hospital 12

    Saratov, 410039

Other trials in Russia

France5 sites

  • Nouvelles Cliniques Nantaises

    Nantes, 44200

  • CHU La Miletrie

    Poitiers, 86021

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, 31059

  • Hopital Guy Chatiliez

    Tourcoing, 59200

  • Hopital Guy Chatillez

    Tourcoing, 59200

Other trials in France

Romania5 sites

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

    Brasov, 500283

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

    Bucharest, 010825

  • Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice

    Cluj-Napoca, 400349

  • Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie

    Craiova, Dolj, 200642

  • Elit Medical SRL

    Ploieşti, 100018

Other trials in Romania

Lithuania4 sites

  • PI Kaunas Silainiai Outpatient Clinic

    Kaunas, LT-48259

  • Private Clinic Elite Medicale

    Kaunas, LT-50177

  • PI Klaipeda Seamen Hospital

    Klaipėda, LT-92288

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Taiwan4 sites

  • Cardinal Tien Hospital

    New Taipei City, 23148

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

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.

Conditions
Hyperlipidemia
Being tested
Bococizumab (PF-04950615; RN316), Placebo
Keywords
mixed dyslipidemia, high risk of cardiovascular events, multiple cardiovascular disease risk factors
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bococizumab (PF-04950615; RN316)Drug

    150 mg every 2 weeks, subcutaneous injection, 12 months

  • PlaceboOther

    subcutaneous injection every 2 weeks for 12 months

Study groups in NCT01968967
Study groupRoleWhat they receive
Bococizumab (PF-04950615; RN316)ExperimentalNot described
Receives: Drug: Bococizumab (PF-04950615; RN316)
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Measured: Baseline, Week 12

Secondary outcomes (30)

  1. Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  2. Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  3. Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  4. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  5. 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

    Measured: Baseline, Week 12, 24, 52

  6. Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  7. Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  8. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period

    Measured: Baseline, Week 24, 52

  9. Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  10. Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  11. Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  12. Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  13. 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

    Measured: Baseline, Week 12

  14. 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

    Measured: Baseline, Week 12

  15. Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Measured: Baseline, Week 12

  16. Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

    Measured: Baseline, Week 12

  17. Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Measured: Baseline, Week 12

  18. Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12

    Measured: Baseline, Week 12

  19. Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12

    Measured: Baseline, Week 12

  20. Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Measured: Baseline, Week 12

  21. Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  22. Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  23. 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

    Measured: Week 12, 24, 52

  24. 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

    Measured: Week 12, 24, 52

  25. Plasma Concentration of PF-04950615 at Week 12, 24 and 52

    Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.

    Measured: Week 12, 24, 52

  26. Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

    Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.

    Measured: Baseline up to Week 58

  27. Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period

    Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.

    Measured: Baseline up to Week 58

  28. Number of Participants Who Changed Concomitant Medication During Extension Period

    In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.

    Measured: Week 58 follow-up visit to Week 110

  29. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period

    Measured: Baseline, Week 58 follow-up visit, 71, 84, 97, 110

  30. Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period

    Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.

    Measured: Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2013 (estimated)
  2. Study start29 Oct 2013
  3. Primary completion5 Jul 2016
  4. Study completion10 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01968967
Sponsor's protocol ID
B1481020
Other IDs
2013-002643-28, SPIRE-LDL
Acronym
SPIRE-LDL
Status last verified
Jul 2018
First submitted
21 Oct 2013
Last updated
31 Jul 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37994400

  • 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.

    PubMed 37658997

  • 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.

    PubMed 35277540

  • 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.

    PubMed 29685591

  • 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.

    PubMed 28304227

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bococizumab (PF-04950615; RN316) in people with Hyperlipidemia, run by Pfizer at 249 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 249 sites in United States, United Kingdom, Canada, Colombia, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01968967, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.

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