Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
SPIRE-LL
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
3 other identifiers
interventional
746
12 countries
223
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Typical duration for phase_3
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 1, 2014
CompletedStudy Start
First participant enrolled
October 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2017
CompletedResults Posted
Study results publicly available
July 21, 2017
CompletedJuly 31, 2018
July 1, 2018
1.7 years
March 27, 2014
June 23, 2017
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline, Week 12
Secondary Outcomes (30)
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
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
Baseline, Week 12, 24, 52
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
Baseline, Week 12, 24, 52
- +25 more secondary outcomes
Study Arms (2)
Bococizumab (PF-04950615; RN316)
EXPERIMENTALBococizumab (PF-04950615; RN316)
placebo
PLACEBO COMPARATORInterventions
150 mg every 2 weeks, subcutaneous injection for 52 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or breastfeeding females
- Cardiovascular or cerebrovascular event or procedure within 90 days
- Congestive heart failure NYHA class IV
- Poorly controlled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (223)
Advanced Cardiovascular, LLC Research
Alexander City, Alabama, 35010, United States
Advanced Cardiovascular, LLC, Research
Auburn, Alabama, 36830, United States
Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
Phoenix, Arizona, 85018, United States
Clinical Research Advantage, Inc./Family Practice Specialists, LTD
Phoenix, Arizona, 85018, United States
Radiant Research, Inc.
Tucson, Arizona, 85712, United States
Radiant Research, Inc
Tucson, Arizona, 85712, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
The Office of Larry Watkins, MD
Little Rock, Arkansas, 72205, United States
American Institute of Research
Los Angeles, California, 90017, United States
lntermed Group
Los Angeles, California, 90017, United States
IMD Medical Group
Los Angeles, California, 90020, United States
The Office of Lucita M. Cruz, M.D., Inc.
Norwalk, California, 90650, United States
Superior Research, LLC
Sacramento, California, 95825, United States
Superior Research ,LLC
Sacramento, California, 95831, United States
Radiant Research, Inc.
Santa Rosa, California, 95405, United States
Orange County Research Center
Tustin, California, 92780, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Clinical Research Advantage, Inc. / Colorado Springs Family Practice
Colorado Springs, Colorado, 80909, United States
Creekside Endocrine Associates, PC
Denver, Colorado, 80209, United States
Boca Raton Clinical Research Associates
Boca Raton, Florida, 33432, United States
BRCR Medical Center, Inc.
Boca Raton, Florida, 33432, United States
Meridien Research
Brooksville, Florida, 34601, United States
Linfritz Research Institute Inc.
Coral Gables, Florida, 33134, United States
Florida Health Center
Fort Lauderdale, Florida, 33312, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, 33012, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
Sunrise Research Institute, Inc
Miami, Florida, 33130, United States
Prestige Clinical Research Center, Inc.
Miami, Florida, 33133, United States
Suncoast Research Group, LLD
Miami, Florida, 33135, United States
Elite Clinical Research
Miami, Florida, 33144, United States
Advanced Clinical Research of Miami
Miami, Florida, 33155, United States
The Research Specialists of Florida, Inc.
Miami, Florida, 33162, United States
Columbus Clinical Services, LLC
Miami, Florida, 33165, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, 33140, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Precision Research Organization
Miami Lakes, Florida, 33016, United States
First Quality
Miramar, Florida, 33025, United States
American Family Medical
Ocala, Florida, 34471, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Andres Patron, D.O.P.A.
Pembroke Pines, Florida, 33026, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, 33026, United States
DBC Research USA
Pembroke Pines, Florida, 33029, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Accord Clinical Research, Llc
Port Orange, Florida, 32129, United States
East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
Saint Augustine, Florida, 32086, United States
East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
Saint Augustine, Florida, 32086, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Meridien Research
Tampa, Florida, 33634, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704, United States
American Health Network of Indiana, LLC
Avon, Indiana, 46123, United States
Heartland Research Associates, LLC
Augusta, Kansas, 67010, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Northwest Family Physicians
Wichita, Kansas, 67205, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Imperial Health, LLP
Lake Charles, Louisiana, 70601, United States
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, 70006, United States
Clinical Trials of America LA
Monroe, Louisiana, 71201, United States
Bethesda Health Research
Bethesda, Maryland, 208174, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
McLaren Flint
Flint, Michigan, 48532, United States
CentraCare Heart & Vascular Center @ St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
CentraCare Heart & Vascular Center at St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Riser Medical Research
Picayune, Mississippi, 39466, United States
Washington University, The Center for Advanced Medicine
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, United States
Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
Fremont, Nebraska, 68025, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, 03801, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Physician's East Endocrinology
Greenville, North Carolina, 27834, United States
Physician's East P.A.
Greenville, North Carolina, 27834, United States
Physician's East, PA
Greenville, North Carolina, 27834, United States
Catawba Valley Medical Group, Inc.
Hickory, North Carolina, 28601, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, 28601, United States
PMG Research of Hickory
Hickory, North Carolina, 28602, United States
Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina, 27612, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Primed Clinical Research
Dayton, Ohio, 45419, United States
Office of Daniel G. Williams, MD
Perrysburg, Ohio, 43551, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135, United States
Castlerock Clinical Research Consultants,LLC
Tulsa, Oklahoma, 74136, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, 19610, United States
Medical Research South, LLC
Charleston, South Carolina, 29407, United States
Ellipsis Research Group, LLC
Columbia, South Carolina, 29204, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, 38138, United States
Apex Cardiology
Jackson, Tennessee, 38301, United States
Research Associates of Jackson
Jackson, Tennessee, 38301, United States
PMG Research, Inc d/b/a PMG Research of Knoxville
Knoxville, Tennessee, 37912, United States
Punzi Medical Center
Carrollton, Texas, 75006, United States
Juno Research, LLC
Houston, Texas, 77036, United States
Gulf Coast Medical Research,LLC
Houston, Texas, 77081, United States
Office of Michelle Zaniewski MD., PA.
Houston, Texas, 77090, United States
Juno Research, LLC
Katy, Texas, 77450, United States
Gulf Coast Medical Research, LLC
Missouri City, Texas, 77459, United States
Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
Plano, Texas, 75093, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78205, United States
Gulf Coast Medical Research, LLC
Sugar Land, Texas, 77478, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
Millennium Clinical Trials, LLC
Arlington, Virginia, 22207, United States
National Clinical Research-Norfolk, Inc.
Norfolk, Virginia, 23502, United States
Sound Health Care Center
Port Orchard, Washington, 98366, United States
Sound Medical Research
Port Orchard, Washington, 98366, United States
Walla Walla Clinic
Walla Walla, Washington, 99362, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53142, United States
HFM Heart and Vascular Center/Holy Family Memorial, Inc
Manitowoc, Wisconsin, 54220, United States
LMC Clinical Research Inc. (Calgary)
Calgary, Alberta, T2H 2G4, Canada
Office of Dr. Ronald Collette MD
Burnaby, British Columbia, V5G 1T4, Canada
Medical Arts Health Research Group
Kamloops, British Columbia, V2C 1K7, Canada
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 1V6, Canada
Glover Medical Clinic
Langley, British Columbia, V3A 4H9, Canada
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4, Canada
The Medical Arts Health Research Group
Penticton, British Columbia, V2A 5C8, Canada
The Office of James K. Lai, MD Inc.
Vancouver, British Columbia, V5Z 1K3, Canada
Cook Street Medical Clinic
Victoria, British Columbia, V8V 4A1, Canada
LMC Clinical Research Inc. (Barrie)
Barrie, Ontario, L4M 7G1, Canada
LMC Clinical Research Inc. (Brampton)
Brampton, Ontario, L6S 0C9, Canada
Aggarwal And Associates Ltd
Brampton, Ontario, L6T 0G1, Canada
Corunna Medical Research Centre
Corunna, Ontario, N0N 1G0, Canada
LMC Clinical Research Inc. (Etobicoke)
Etobicoke, Ontario, M9R 4E1, Canada
LMC Clinical Research Inc. (Markham)
Markham, Ontario, L6B 0P9, Canada
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8, Canada
LMC Clinical Research Inc. (Oakville)
Oakville, Ontario, L6M 1M1, Canada
The Office of Dr. James Cha
Oshawa, Ontario, L1J 2K1, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2, Canada
Scarborough Cardiology Research
Scarborough Village, Ontario, M1E 5E9, Canada
LMC Clinical Research Inc. (Thornhill)
Thornhill, Ontario, L4J 8L7, Canada
Rouge Valley Health System - Centenary
Toronto, Ontario, M1E 4B9, Canada
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, M4G 3E8, Canada
Manna Research Inc.
Toronto, Ontario, M9W 4L6, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
ViaCar Recherche Clinique Inc.
Greenfield Park, Quebec, J4V 2G8, Canada
Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud
Longueuil, Quebec, J4M2X1, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Clinique des maladies lipidiques de Quebec
Québec, Quebec, G1V 4W2, Canada
Alpha Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
Centre De Sante Et De Services Sociaux De Beauce (CSSSB)
Saint-Georges, Beauce, Quebec, G5Y 4T8, Canada
C.I.C. Maurice Inc.
Trois-Rivières, Quebec, G8T 7A1, Canada
C.I.C. Mauricie Inc.
Trois-Rivières, Quebec, G8T 7A1, Canada
Kardiologicka ambulance
Trutnov, Královéhradecký kraj, 54101, Czechia
Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
Prague, Vinohrady, 100 34, Czechia
Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
Brno, 656 91, Czechia
Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
Brno, 656 91, Czechia
Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
Kladno, 27280, Czechia
Lekarna - P-P Klinika Kladno
Kladno, 27280, Czechia
Lunacor s.r.o.
Kroměříž, 76701, Czechia
Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
Olomouc, 775 20, Czechia
Lekarna Fakultni nemocnice Olomouc (pharmacy)
Olomouc, 77520, Czechia
Lekarna Domovina
Olomouc, 779 00, Czechia
PreventaMed, s.r.o.
Olomouc, 779 00, Czechia
IKEM, Oddeleni preventivni kardiologie
Prague, 140 21, Czechia
IKEM, Ustavni lekarna
Prague, 140 21, Czechia
BENU lekarna
Příbram, 261 01, Czechia
Kardiologicka ambulance, III. Poliklinika
Příbram, 261 01, Czechia
Lekarna 203-02
Slaný, 274 01, Czechia
Nemocnice Slany, Interni oddeleni
Slaný, 274 01, Czechia
AeskuLab k.s., Lipidova poradna
Teplice, 415 01, Czechia
Lekarna Centrum (pharmacy)
Teplice, 415 01, Czechia
Dr.Max lekarna
Trutnov, 541 01, Czechia
Etela-Karjalan Keskussairaala
Lappeenranta, 53130, Finland
Turku University Hospital
Turku, 20520, Finland
Medisch Spectrum Twente
Enschede, ER, 7513, Netherlands
St Lucas Andreas Hospital
Amsterdam, North Holland, 1061 AE, Netherlands
Gelre Hospitals
Apeldoorn, 7334 DZ, Netherlands
Andromed Eindhoven
Eindhoven, 5611 NV, Netherlands
Medisch Spectrum Twente
Enschede, 7513 ER, Netherlands
Beatrix Hospital
Gorinchem, 4204 AA, Netherlands
Martini Ziekenhuis
Groningen, 9728 NT, Netherlands
Zuyderland Medisch Centrum
Heerlen, 6419 PC, Netherlands
Andro Medical Research B.V.
Rotterdam, 3021 HC, Netherlands
Ikazia Hospital
Rotterdam, 3083AN, Netherlands
D&A Research and Genetics
Sneek, 8601 ZR, Netherlands
St. Elisabeth Hospital
Tilburg, 5022 GC, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Ossum Gronert Legetjeneste AS
Hønefoss, 3515, Norway
Oslo Universitetssykehus HF
Oslo, 0373, Norway
Oslo Universitetssykehus HF, Ulleval
Oslo, 0424, Norway
KO-MED Centra Kliniczne Lublin
Lublin, Lublin Voivodeship, 20-362, Poland
KO-MED Centra Kliniczne Zamosc
Zamość, Lublin Voivodeship, 22-400, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-384, Poland
MCBK Sc lwona Czajkowska Monika Barney
Grodzisk Mazowiecki, 05-825, Poland
Synexus Polska Sp. z o. o. Oddizial w Katowicach.
Katowice, 40-040, Poland
Clinport Tura Lipinska Dabrowski S.C.
Katowice, 40-084, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202, Poland
Jan Zbigniew Peruga NZOZ SALUS
Lodz, 91-302, Poland
Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych
Oława, 55-200, Poland
Synexus Polska Sp. z o.o Oddzial w Poznaniu
Poznan, 60-702, Poland
KO-MED Centra Kliniczne Sp. z o.o.
Puławy, 24-100, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, 50-088, Poland
.WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina
Wroclaw, 51-685, Poland
KO-MED. Centra Kliniczne Staszow
Staszów, Świętokrzyskie Voivodeship, 28-200, Poland
Ponce School Of Medicine
Ponce, PR, 00716, Puerto Rico
Cardiometabolic Research Center, Inc
Ponce, PR, 00717, Puerto Rico
Caparra Internal Medicine
Río Grande, 00745, Puerto Rico
National University Hospital
Singapore, 119228, Singapore
National Heart Centre Singapore
Singapore, 169609, Singapore
Sacred Heart Hospital-Hallym University
Anyang-si, Gyeonggi-do, 431-796, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Clinical Trial Center (CTC)/Centrum foer klinisk proevning
Gothenburg, 413 45, Sweden
Vardcentralen Lessebo
Lessebo, 360 50, Sweden
Clinical Trials Consultants AB
Linköping, 58758, Sweden
ProbarE i Lund AB
Lund, 222 22, Sweden
Capio Citykliniken Hjartmottagning
Lund, 22221, Sweden
Dalecarlia Clinical Research Center
Rättvik, 79530, Sweden
Citydiabetes
Stockholm, 111 57, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, 141 86, Sweden
Synexus Thames Valley Clinical Research Centre
Reading, Berkshire, RG2 0TG, United Kingdom
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, Lanarkshire Scotland, G20 0SP, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, PR7 7NA, United Kingdom
Synexus North East Clinical Research Centre - Hexham General Hospital
Hexham, Northumberland, NE46 1QJ, United Kingdom
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
Worcester, Worcestershire, WR5 1DD, United Kingdom
University Hospital Ayr - Nhs Ayrshire And Arran
Ayr, KA6 6DX, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, HU3 2JZ, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool, L22 0LG, United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, M15 6SX, United Kingdom
Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,
Swansea, SA2 8PP, United Kingdom
Related Publications (5)
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.
PMID: 37994400DERIVEDMcCush 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.
PMID: 37658997DERIVEDChasman 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.
PMID: 35277540DERIVEDRidker 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.
PMID: 29685591DERIVEDRidker 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.
PMID: 28304227DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 1, 2014
Study Start
October 28, 2014
Primary Completion
July 15, 2016
Study Completion
July 10, 2017
Last Updated
July 31, 2018
Results First Posted
July 21, 2017
Record last verified: 2018-07