AzTrials
AzTrials

HyperlipidemiaPhase 3SPIRE-LLNCT02100514

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary 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 223 sites in 12 countries.

Completed

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

Official record
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Trial 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. 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
746 participants
Where
223 sitesin 12 countries
Study dates
28 Oct 2014to 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 >=100 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 or procedure within 90 days
  • Congestive heart failure NYHA class IV
  • Poorly controlled hypertension

Trial locations and contacts

223 sites in 12 countries.

223 sites in 12 countries

United States108 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Advanced Cardiovascular, LLC Research

    Alexander City, Alabama, 35010

  • Millennium Clinical Trials, LLC

    Arlington, Virginia, 22207

  • Advanced Cardiovascular, LLC, Research

    Auburn, Alabama, 36830

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • American Health Network of Indiana, LLC

    Avon, Indiana, 46123

  • Bethesda Health Research

    Bethesda, Maryland, 208174

  • Boca Raton Clinical Research Associates

    Boca Raton, Florida, 33432

  • BRCR Medical Center, Inc.

    Boca Raton, Florida, 33432

  • Northwest Clinical Trials, Inc.

    Boise, Idaho, 83704

  • Meridien Research

    Brooksville, Florida, 34601

  • Punzi Medical Center

    Carrollton, Texas, 75006

  • Medical Research South, LLC

    Charleston, South Carolina, 29407

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

    Colorado Springs, Colorado, 80909

  • Ellipsis Research Group, LLC

    Columbia, South Carolina, 29204

  • Linfritz Research Institute Inc.

    Coral Gables, Florida, 33134

  • Primed Clinical Research

    Dayton, Ohio, 45419

  • Creekside Endocrine Associates, PC

    Denver, Colorado, 80209

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • McLaren Flint

    Flint, Michigan, 48532

  • Florida Health Center

    Fort Lauderdale, Florida, 33312

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

    Fremont, Nebraska, 68025

  • Stern Cardiovascular Foundation, Inc

    Germantown, Tennessee, 38138

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834

  • Physician's East P.A.

    Greenville, North Carolina, 27834

  • Physician's East, PA

    Greenville, North Carolina, 27834

  • Harleysville Medical Associates

    Harleysville, Pennsylvania, 19438

  • Health Care Family Rehab & Research Center

    Hialeah, Florida, 33012

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • Catawba Valley Medical Group, Inc.

    Hickory, North Carolina, 28601

  • Clinical Trials of America, Inc.

    Hickory, North Carolina, 28601

  • PMG Research of Hickory

    Hickory, North Carolina, 28602

  • Juno Research, LLC

    Houston, Texas, 77036

  • Gulf Coast Medical Research,LLC

    Houston, Texas, 77081

  • Office of Michelle Zaniewski MD., PA.

    Houston, Texas, 77090

  • Apex Cardiology

    Jackson, Tennessee, 38301

  • Research Associates of Jackson

    Jackson, Tennessee, 38301

  • Juno Research, LLC

    Katy, Texas, 77450

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53142

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

    Knoxville, Tennessee, 37912

  • Imperial Health, LLP

    Lake Charles, Louisiana, 70601

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • The Office of Larry Watkins, MD

    Little Rock, Arkansas, 72205

  • American Institute of Research

    Los Angeles, California, 90017

  • lntermed Group

    Los Angeles, California, 90017

  • IMD Medical Group

    Los Angeles, California, 90020

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

    Manitowoc, Wisconsin, 54220

  • Crescent City Clinical Research Center, LLC

    Metairie, Louisiana, 70006

  • Sunrise Research Institute, Inc

    Miami, Florida, 33130

  • Prestige Clinical Research Center, Inc.

    Miami, Florida, 33133

  • Suncoast Research Group, LLD

    Miami, Florida, 33135

  • Elite Clinical Research

    Miami, Florida, 33144

  • Advanced Clinical Research of Miami

    Miami, Florida, 33155

  • The Research Specialists of Florida, Inc.

    Miami, Florida, 33162

  • Columbus Clinical Services, LLC

    Miami, Florida, 33165

  • NewPhase Clinical Trials, Corp.

    Miami Beach, Florida, 33140

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Precision Research Organization

    Miami Lakes, Florida, 33016

  • First Quality

    Miramar, Florida, 33025

  • Gulf Coast Medical Research, LLC

    Missouri City, Texas, 77459

  • Clinical Trials of America LA

    Monroe, Louisiana, 71201

  • National Clinical Research-Norfolk, Inc.

    Norfolk, Virginia, 23502

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

    Norwalk, California, 90650

  • American Family Medical

    Ocala, Florida, 34471

  • Renstar Medical Research

    Ocala, Florida, 34471

  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma, 73135

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Andres Patron, D.O.P.A.

    Pembroke Pines, Florida, 33026

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida, 33026

  • DBC Research USA

    Pembroke Pines, Florida, 33029

  • Office of Daniel G. Williams, MD

    Perrysburg, Ohio, 43551

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

    Phoenix, Arizona, 85018

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

    Phoenix, Arizona, 85018

  • Riser Medical Research

    Picayune, Mississippi, 39466

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

    Plano, Texas, 75093

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Accord Clinical Research, Llc

    Port Orange, Florida, 32129

  • Sound Health Care Center

    Port Orchard, Washington, 98366

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • ActivMed Practices & Research, Inc.

    Portsmouth, New Hampshire, 03801

  • Wake Internal Medicine Consultants, Inc.

    Raleigh, North Carolina, 27612

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Superior Research, LLC

    Sacramento, California, 95825

  • Superior Research ,LLC

    Sacramento, California, 95831

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

    Saint Augustine, Florida, 32086

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

    Saint Augustine, Florida, 32086

  • CentraCare Heart & Vascular Center @ St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • CentraCare Heart & Vascular Center at St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78205

  • Radiant Research, Inc.

    Santa Rosa, California, 95405

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Washington University, The Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Gulf Coast Medical Research, LLC

    Sugar Land, Texas, 77478

  • Meridien Research

    Tampa, Florida, 33634

  • Radiant Research, Inc.

    Tucson, Arizona, 85712

  • Radiant Research, Inc

    Tucson, Arizona, 85712

  • Castlerock Clinical Research Consultants,LLC

    Tulsa, Oklahoma, 74136

  • Orange County Research Center

    Tustin, California, 92780

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Walla Walla Clinic

    Walla Walla, Washington, 99362

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Northwest Family Physicians

    Wichita, Kansas, 67205

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada33 sites

  • LMC Clinical Research Inc. (Barrie)

    Barrie, Ontario, L4M 7G1

  • LMC Clinical Research Inc. (Brampton)

    Brampton, Ontario, L6S 0C9

  • Aggarwal And Associates Ltd

    Brampton, Ontario, L6T 0G1

  • Office of Dr. Ronald Collette MD

    Burnaby, British Columbia, V5G 1T4

  • LMC Clinical Research Inc. (Calgary)

    Calgary, Alberta, T2H 2G4

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Corunna Medical Research Centre

    Corunna, Ontario, N0N 1G0

  • LMC Clinical Research Inc. (Etobicoke)

    Etobicoke, Ontario, M9R 4E1

  • ViaCar Recherche Clinique Inc.

    Greenfield Park, Quebec, J4V 2G8

  • Medical Arts Health Research Group

    Kamloops, British Columbia, V2C 1K7

  • The Medical Arts Health Research Group

    Kelowna, British Columbia, V1Y 1V6

  • Glover Medical Clinic

    Langley, British Columbia, V3A 4H9

  • Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud

    Longueuil, Quebec, J4M2X1

  • LMC Clinical Research Inc. (Markham)

    Markham, Ontario, L6B 0P9

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Fraser Clinical Trials

    New Westminster, British Columbia, V3L 3W4

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • LMC Clinical Research Inc. (Oakville)

    Oakville, Ontario, L6M 1M1

  • The Office of Dr. James Cha

    Oshawa, Ontario, L1J 2K1

  • The Medical Arts Health Research Group

    Penticton, British Columbia, V2A 5C8

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • Clinique des maladies lipidiques de Quebec

    Québec, Quebec, G1V 4W2

  • Alpha Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Centre De Sante Et De Services Sociaux De Beauce (CSSSB)

    Saint-Georges, Beauce, Quebec, G5Y 4T8

  • Scarborough Cardiology Research

    Scarborough Village, Ontario, M1E 5E9

  • LMC Clinical Research Inc. (Thornhill)

    Thornhill, Ontario, L4J 8L7

  • Rouge Valley Health System - Centenary

    Toronto, Ontario, M1E 4B9

  • LMC Clinical Research Inc. (Bayview)

    Toronto, Ontario, M4G 3E8

  • Manna Research Inc.

    Toronto, Ontario, M9W 4L6

  • C.I.C. Maurice Inc.

    Trois-Rivières, Quebec, G8T 7A1

  • C.I.C. Mauricie Inc.

    Trois-Rivières, Quebec, G8T 7A1

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

    Vancouver, British Columbia, V5Z 1K3

  • Cook Street Medical Clinic

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

Czechia20 sites

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

    Brno, 656 91

  • Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)

    Brno, 656 91

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

    Kladno, 27280

  • Lekarna - P-P Klinika Kladno

    Kladno, 27280

  • Lunacor s.r.o.

    Kroměříž, 76701

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

    Olomouc, 775 20

  • Lekarna Fakultni nemocnice Olomouc (pharmacy)

    Olomouc, 77520

  • Lekarna Domovina

    Olomouc, 779 00

  • PreventaMed, s.r.o.

    Olomouc, 779 00

  • Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika

    Prague, Vinohrady, 100 34

  • IKEM, Oddeleni preventivni kardiologie

    Prague, 140 21

  • IKEM, Ustavni lekarna

    Prague, 140 21

  • BENU lekarna

    Příbram, 261 01

  • Kardiologicka ambulance, III. Poliklinika

    Příbram, 261 01

  • Lekarna 203-02

    Slaný, 274 01

  • Nemocnice Slany, Interni oddeleni

    Slaný, 274 01

  • AeskuLab k.s., Lipidova poradna

    Teplice, 415 01

  • Lekarna Centrum (pharmacy)

    Teplice, 415 01

  • Kardiologicka ambulance

    Trutnov, Hradec Králové Region, 54101

  • Dr.Max lekarna

    Trutnov, 541 01

Other trials in Czechia

Poland15 sites

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

    Gdynia, 81-384

  • MCBK Sc lwona Czajkowska Monika Barney

    Grodzisk Mazowiecki, 05-825

  • Synexus Polska Sp. z o. o. Oddizial w Katowicach.

    Katowice, 40-040

  • Clinport Tura Lipinska Dabrowski S.C.

    Katowice, 40-084

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202

  • Jan Zbigniew Peruga NZOZ SALUS

    Lodz, 91-302

  • KO-MED Centra Kliniczne Lublin

    Lublin, Lublin Voivodeship, 20-362

  • Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych

    Oława, 55-200

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

    Poznan, 60-702

  • KO-MED Centra Kliniczne Sp. z o.o.

    Puławy, 24-100

  • KO-MED. Centra Kliniczne Staszow

    Staszów, Świętokrzyskie Voivodeship, 28-200

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

    Warsaw, 01-192

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

    Wroclaw, 50-088

  • .WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina

    Wroclaw, 51-685

  • KO-MED Centra Kliniczne Zamosc

    Zamość, Lublin Voivodeship, 22-400

Other trials in Poland

Netherlands13 sites

  • St Lucas Andreas Hospital

    Amsterdam, North Holland, 1061 AE

  • Gelre Hospitals

    Apeldoorn, 7334 DZ

  • Andromed Eindhoven

    Eindhoven, 5611 NV

  • Medisch Spectrum Twente

    Enschede, ER, 7513

  • Medisch Spectrum Twente

    Enschede, 7513 ER

  • Beatrix Hospital

    Gorinchem, 4204 AA

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Andro Medical Research B.V.

    Rotterdam, 3021 HC

  • Ikazia Hospital

    Rotterdam, 3083AN

  • D&A Research and Genetics

    Sneek, 8601 ZR

  • St. Elisabeth Hospital

    Tilburg, 5022 GC

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

United Kingdom12 sites

  • University Hospital Ayr - Nhs Ayrshire And Arran

    Ayr, KA6 6DX

  • Synexus Midlands Clinical Research Centre

    Birmingham, B15 2SQ

  • Synexus Lancashire Clinical Research Centre

    Chorley, Lancashire, PR7 7NA

  • Synexus Scotland Clinical Research Centre

    Glasgow, Lanarkshire Scotland, G20 0SP

  • Synexus North East Clinical Research Centre - Hexham General Hospital

    Hexham, Northumberland, NE46 1QJ

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, HU3 2JZ

  • Synexus Merseyside Clinical Research Centre

    Liverpool, L22 0LG

  • Synexus Manchester Clinical Research Centre

    Manchester, M15 6SX

  • Synexus Thames Valley Clinical Research Centre

    Reading, Berkshire, RG2 0TG

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester, M6 8HD

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

    Swansea, SA2 8PP

  • Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital

    Worcester, Worcestershire, WR5 1DD

Other trials in United Kingdom

Sweden8 sites

  • Clinical Trial Center (CTC)/Centrum foer klinisk proevning

    Gothenburg, 413 45

  • Vardcentralen Lessebo

    Lessebo, 360 50

  • Clinical Trials Consultants AB

    Linköping, 58758

  • ProbarE i Lund AB

    Lund, 222 22

  • Capio Citykliniken Hjartmottagning

    Lund, 22221

  • Dalecarlia Clinical Research Center

    Rättvik, 79530

  • Citydiabetes

    Stockholm, 111 57

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 141 86

Other trials in Sweden

South Korea4 sites

  • Sacred Heart Hospital-Hallym University

    Anyang-si, Gyeonggi-do, 431-796

  • Dong-A University Hospital

    Busan, 49201

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 11923

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

    Seoul, 137-701

Other trials in South Korea

Norway3 sites

  • Ossum Gronert Legetjeneste AS

    Hønefoss, 3515

  • Oslo Universitetssykehus HF

    Oslo, 0373

  • Oslo Universitetssykehus HF, Ulleval

    Oslo, 0424

Other trials in Norway

Puerto Rico3 sites

  • Ponce School Of Medicine

    Ponce, PR, 00716

  • Cardiometabolic Research Center, Inc

    Ponce, PR, 00717

  • Caparra Internal Medicine

    Rio Grande, 00745

Other trials in Puerto Rico

Finland2 sites

  • Etela-Karjalan Keskussairaala

    Lappeenranta, 53130

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Heart Centre Singapore

    Singapore, 169609

Other trials in Singapore

About this study

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

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.

Conditions
Hyperlipidemia
Being tested
Bococizumab (PF-04950615; RN316), Placebo
Keywords
Primary hyperlipidemia or 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 for 52 weeks.

  • PlaceboOther

    Subcutaneous injection every 2 weeks for 52 weeks.

Study groups in NCT02100514
Study groupRoleWhat they receive
Bococizumab (PF-04950615; RN316)ExperimentalBococizumab (PF-04950615; RN316)
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 (Non 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 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 (Non 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. Absolute 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 Versus Time Summary of PF-04950615

    Measured: Week 12, 24, 52

  26. Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 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 end of study (up to 110 weeks)

  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 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) 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 to Week 110

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

    Measured: Baseline, Week 58 (follow up), 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), 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 posted1 Apr 2014 (estimated)
  2. Study start28 Oct 2014
  3. Primary completion15 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02100514
Sponsor's protocol ID
B1481045
Other IDs
SPIRE-LL, 2014-000478-20, 2014
Acronym
SPIRE-LL
Status last verified
Jul 2018
First submitted
27 Mar 2014
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 223 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 223 sites in United States, Canada, Czechia, Poland, Netherlands 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 21 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 NCT02100514, 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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