Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-LL)
2. juli 2018 oppdatert av: Pfizer
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
746
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Quebec, Canada, G3K 2P8
- Alpha Recherche Clinique
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Quebec, Canada, G1V 4W2
- Clinique des maladies lipidiques de Quebec
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Alberta
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Calgary, Alberta, Canada, T2H 2G4
- LMC Clinical Research Inc. (Calgary)
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British Columbia
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Burnaby, British Columbia, Canada, V5G 1T4
- Office of Dr. Ronald Collette MD
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Kamloops, British Columbia, Canada, V2C 1K7
- Medical Arts Health Research Group
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Kelowna, British Columbia, Canada, V1Y 1V6
- The Medical Arts Health Research Group
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Langley, British Columbia, Canada, V3A 4H9
- Glover Medical Clinic
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New Westminster, British Columbia, Canada, V3L 3W4
- Fraser Clinical Trials
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Penticton, British Columbia, Canada, V2A 5C8
- The Medical Arts Health Research Group
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Vancouver, British Columbia, Canada, V5Z 1K3
- The Office of James K. Lai, MD Inc.
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Victoria, British Columbia, Canada, V8V 4A1
- Cook Street Medical Clinic
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- LMC Clinical Research Inc. (Barrie)
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Brampton, Ontario, Canada, L6T 0G1
- Aggarwal and Associates Ltd
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Brampton, Ontario, Canada, L6S 0C9
- LMC Clinical Research Inc. (Brampton)
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Corunna, Ontario, Canada, N0N 1G0
- Corunna Medical Research Centre
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Etobicoke, Ontario, Canada, M9R 4E1
- LMC Clinical Research Inc. (Etobicoke)
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Markham, Ontario, Canada, L6B 0P9
- LMC Clinical Research Inc. (Markham)
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Newmarket, Ontario, Canada, L3Y 5G8
- SKDS Research Inc.
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Oakville, Ontario, Canada, L6M 1M1
- LMC Clinical Research Inc. (Oakville)
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Oshawa, Ontario, Canada, L1J 2K1
- The Office of Dr. James Cha
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Peterborough, Ontario, Canada, K9J 0B2
- Kawartha Cardiology Clinical Trials
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Scarborough, Ontario, Canada, M1E 5E9
- Scarborough Cardiology Research
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Thornhill, Ontario, Canada, L4J 8L7
- LMC Clinical Research Inc. (Thornhill)
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Toronto, Ontario, Canada, M4G 3E8
- LMC Clinical Research Inc. (Bayview)
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Toronto, Ontario, Canada, M9W 4L6
- Manna Research Inc.
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Toronto, Ontario, Canada, M1E 4B9
- Rouge Valley Health System - Centenary
-
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Quebec
-
Chicoutimi, Quebec, Canada, G7H 7K9
- Ecogene-21
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Greenfield Park, Quebec, Canada, J4V 2G8
- Viacar Recherche Clinique Inc.
-
Longueuil, Quebec, Canada, J4M2X1
- Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
-
Saint-Georges, Beauce, Quebec, Canada, G5Y 4T8
- Centre De Sante Et De Services Sociaux De Beauce (CSSSB)
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Trois-Rivieres, Quebec, Canada, G8T 7A1
- C.I.C. Mauricie inc.
-
Trois-Rivieres, Quebec, Canada, G8T 7A1
- C.I.C. Maurice Inc.
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-
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-
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Lappeenranta, Finland, 53130
- Etela-Karjalan Keskussairaala
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Turku, Finland, 20520
- Turku University Hospital
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-
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Alabama
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Alexander City, Alabama, Forente stater, 35010
- Advanced Cardiovascular, LLC Research
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Auburn, Alabama, Forente stater, 36830
- Advanced Cardiovascular, LLC, Research
-
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Arizona
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Phoenix, Arizona, Forente stater, 85018
- Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
-
Phoenix, Arizona, Forente stater, 85018
- Clinical Research Advantage, Inc./Family Practice Specialists, LTD
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Tucson, Arizona, Forente stater, 85712
- Radiant Research, Inc.
-
Tucson, Arizona, Forente stater, 85712
- Radiant Research, Inc
-
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Lynn Institute of the Ozarks
-
Little Rock, Arkansas, Forente stater, 72205
- The Office of Larry Watkins, MD
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California
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Los Angeles, California, Forente stater, 90017
- American Institute of Research
-
Los Angeles, California, Forente stater, 90020
- IMD Medical Group
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Los Angeles, California, Forente stater, 90017
- lntermed Group
-
Norwalk, California, Forente stater, 90650
- The Office of Lucita M. Cruz, M.D., Inc.
-
Sacramento, California, Forente stater, 95825
- Superior Research, LLC
-
Sacramento, California, Forente stater, 95831
- Superior Research ,LLC
-
Santa Rosa, California, Forente stater, 95405
- Radiant Research, Inc.
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Tustin, California, Forente stater, 92780
- Orange County Research Center
-
Ventura, California, Forente stater, 93003
- Ventura Clinical Trials
-
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Colorado
-
Aurora, Colorado, Forente stater, 80045
- University of Colorado Hospital
-
Colorado Springs, Colorado, Forente stater, 80909
- Clinical Research Advantage, Inc. / Colorado Springs Family Practice
-
Denver, Colorado, Forente stater, 80209
- Creekside Endocrine Associates, PC
-
-
Florida
-
Boca Raton, Florida, Forente stater, 33432
- Boca Raton Clinical Research Associates
-
Boca Raton, Florida, Forente stater, 33432
- BRCR Medical Center, Inc.
-
Brooksville, Florida, Forente stater, 34601
- Meridien Research
-
Coral Gables, Florida, Forente stater, 33134
- Linfritz Research Institute Inc.
-
Fort Lauderdale, Florida, Forente stater, 33312
- Florida Health Center
-
Hialeah, Florida, Forente stater, 33012
- Indago Research & Health Center, Inc.
-
Hialeah, Florida, Forente stater, 33012
- Health Care Family Rehab & Research Center
-
Miami, Florida, Forente stater, 33144
- Elite Clinical Research
-
Miami, Florida, Forente stater, 33130
- Sunrise Research Institute, Inc
-
Miami, Florida, Forente stater, 33133
- Prestige Clinical Research Center, Inc.
-
Miami, Florida, Forente stater, 33155
- Advanced Clinical Research of Miami
-
Miami, Florida, Forente stater, 33135
- Suncoast Research Group, LLD
-
Miami, Florida, Forente stater, 33162
- The Research Specialists of Florida, Inc.
-
Miami, Florida, Forente stater, 33165
- Columbus Clinical Services, LLC
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Miami Beach, Florida, Forente stater, 33140
- NewPhase Clinical Trials, Corp.
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Miami Lakes, Florida, Forente stater, 33014
- Panax Clinical Research
-
Miami Lakes, Florida, Forente stater, 33016
- Precision Research Organization
-
Miramar, Florida, Forente stater, 33025
- First Quality
-
Ocala, Florida, Forente stater, 34471
- Renstar Medical Research
-
Ocala, Florida, Forente stater, 34471
- American Family Medical
-
Pembroke Pines, Florida, Forente stater, 33026
- Pines Care Research Center, LLC
-
Pembroke Pines, Florida, Forente stater, 33029
- DBC Research USA
-
Pembroke Pines, Florida, Forente stater, 33026
- Andres Patron, D.O.P.A.
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Port Orange, Florida, Forente stater, 32129
- Accord Clinical Research, LLC
-
Port Orange, Florida, Forente stater, 32127
- Progressive Medical Research
-
Saint Augustine, Florida, Forente stater, 32086
- East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
-
Saint Augustine, Florida, Forente stater, 32086
- East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
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Saint Petersburg, Florida, Forente stater, 33709
- Meridien Research
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Sarasota, Florida, Forente stater, 34239
- Cardiovascular Center of Sarasota
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Tampa, Florida, Forente stater, 33634
- Meridien Research
-
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Idaho
-
Boise, Idaho, Forente stater, 83704
- Northwest Clinical Trials, Inc.
-
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Indiana
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Avon, Indiana, Forente stater, 46123
- American Health Network of Indiana, LLC
-
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Kansas
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Augusta, Kansas, Forente stater, 67010
- Heartland Research Associates, LLC
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Wichita, Kansas, Forente stater, 67205
- Heartland Research Associates, LLC
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Wichita, Kansas, Forente stater, 67207
- Heartland Research Associates, LLC
-
Wichita, Kansas, Forente stater, 67205
- Northwest Family Physicians
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Louisiana
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Lake Charles, Louisiana, Forente stater, 70601
- Imperial Health, LLP
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Metairie, Louisiana, Forente stater, 70006
- Crescent City Clinical Research Center, LLC
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Monroe, Louisiana, Forente stater, 71201
- Clinical Trials of America LA
-
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Maryland
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Bethesda, Maryland, Forente stater, 208174
- Bethesda Health Research
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Elkridge, Maryland, Forente stater, 21075
- Centennial Medical Group
-
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Michigan
-
Flint, Michigan, Forente stater, 48532
- McLaren Flint
-
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Minnesota
-
Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Heart & Vascular Center @ St. Cloud Hospital
-
Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Heart & Vascular Center at St. Cloud Hospital
-
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Mississippi
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Picayune, Mississippi, Forente stater, 39466
- Riser Medical Research
-
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Missouri
-
Saint Louis, Missouri, Forente stater
- Washington University School of Medicine
-
Saint Louis, Missouri, Forente stater, 63110
- Washington University, The Center for Advanced Medicine
-
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Nebraska
-
Fremont, Nebraska, Forente stater, 68025
- Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
-
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New Hampshire
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Portsmouth, New Hampshire, Forente stater, 03801
- ActivMed Practices & Research, Inc.
-
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87102
- Albuquerque Clinical Trials, Inc.
-
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North Carolina
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Greenville, North Carolina, Forente stater, 27834
- Physician's East Endocrinology
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Greenville, North Carolina, Forente stater, 27834
- Physician's East, PA
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Greenville, North Carolina, Forente stater, 27834
- Physician's East P.A.
-
Hickory, North Carolina, Forente stater, 28601
- Clinical Trials of America, Inc.
-
Hickory, North Carolina, Forente stater, 28602
- PMG Research of Hickory
-
Hickory, North Carolina, Forente stater, 28601
- Catawba Valley Medical Group, Inc.
-
Raleigh, North Carolina, Forente stater, 27612
- Wake Research Associates, LLC
-
Raleigh, North Carolina, Forente stater, 27612
- Wake Internal Medicine Consultants, Inc.
-
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Ohio
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Dayton, Ohio, Forente stater, 45419
- PriMED Clinical Research
-
Perrysburg, Ohio, Forente stater, 43551
- Office of Daniel G. Williams, MD
-
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73135
- South Oklahoma Heart Research, LLC
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Tulsa, Oklahoma, Forente stater, 74136
- Castlerock Clinical Research Consultants,LLC
-
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Pennsylvania
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Harleysville, Pennsylvania, Forente stater, 19438
- Harleysville Medical Associates
-
Wyomissing, Pennsylvania, Forente stater, 19610
- Berks Cardiologists, Ltd.
-
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South Carolina
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Charleston, South Carolina, Forente stater, 29407
- Medical Research South, LLC
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Columbia, South Carolina, Forente stater, 29204
- Ellipsis Research Group, LLC
-
Spartanburg, South Carolina, Forente stater, 29303
- Spartanburg Medical Research
-
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Tennessee
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Germantown, Tennessee, Forente stater, 38138
- Stern Cardiovascular Foundation, Inc
-
Jackson, Tennessee, Forente stater, 38301
- Research Associates Of Jackson
-
Jackson, Tennessee, Forente stater, 38301
- Apex Cardiology
-
Knoxville, Tennessee, Forente stater, 37912
- PMG Research, Inc d/b/a PMG Research of Knoxville
-
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Texas
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Carrollton, Texas, Forente stater, 75006
- Punzi Medical Center
-
Houston, Texas, Forente stater, 77036
- Juno Research, LLC
-
Houston, Texas, Forente stater, 77090
- Office of Michelle Zaniewski MD., PA.
-
Houston, Texas, Forente stater, 77081
- Gulf Coast Medical Research,LLC
-
Katy, Texas, Forente stater, 77450
- Juno Research, LLC
-
Missouri City, Texas, Forente stater, 77459
- Gulf Coast Medical Research, LLC
-
Plano, Texas, Forente stater, 75093
- Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
-
San Antonio, Texas, Forente stater, 78205
- Clinical Trials of Texas, Inc.
-
Sugar Land, Texas, Forente stater, 77478
- Gulf Coast Medical Research, LLC
-
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Utah
-
Orem, Utah, Forente stater, 84058
- Aspen Clinical Research
-
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Virginia
-
Arlington, Virginia, Forente stater, 22207
- Millennium Clinical Trials, LLC
-
Norfolk, Virginia, Forente stater, 23502
- National Clinical Research-Norfolk, Inc.
-
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Washington
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Port Orchard, Washington, Forente stater, 98366
- Sound Medical Research
-
Port Orchard, Washington, Forente stater, 98366
- Sound Health Care Center
-
Walla Walla, Washington, Forente stater, 99362
- Walla Walla Clinic
-
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Wisconsin
-
Kenosha, Wisconsin, Forente stater, 53142
- Clinical Investigation Specialists, Inc.
-
Manitowoc, Wisconsin, Forente stater, 54220
- HFM Heart and Vascular Center/Holy Family Memorial, Inc
-
-
-
-
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Busan, Korea, Republikken, 49201
- Dong-A University Hospital
-
Seoul, Korea, Republikken, 137-701
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
-
Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Korea, Republikken, 431-796
- Sacred Heart Hospital-Hallym University
-
Guri-si, Gyeonggi-do, Korea, Republikken, 11923
- Hanyang University Guri Hospital
-
-
-
-
-
Apeldoorn, Nederland, 7334 DZ
- Gelre Hospitals
-
Eindhoven, Nederland, 5611 NV
- Andromed Eindhoven
-
Enschede, Nederland, 7513 ER
- Medisch Spectrum Twente
-
Gorinchem, Nederland, 4204 AA
- Beatrix Hospital
-
Groningen, Nederland, 9728 NT
- Martini Ziekenhuis
-
Heerlen, Nederland, 6419 PC
- Zuyderland Medisch Centrum
-
Rotterdam, Nederland, 3083AN
- Ikazia Hospital
-
Rotterdam, Nederland, 3021 HC
- Andro Medical Research B.V.
-
Sneek, Nederland, 8601 ZR
- D&A Research and Genetics
-
Tilburg, Nederland, 5022 GC
- St. Elisabeth Hospital
-
Utrecht, Nederland, 3584 CX
- University Medical Center Utrecht
-
-
ER
-
Enschede, ER, Nederland, 7513
- Medisch Spectrum Twente
-
-
North Holland
-
Amsterdam, North Holland, Nederland, 1061 AE
- St Lucas Andreas Hospital
-
-
-
-
-
Honefoss, Norge, 3515
- Ossum Gronert Legetjeneste AS
-
Oslo, Norge, 0373
- Oslo Universitetssykehus HF
-
Oslo, Norge, 0424
- Oslo Universitetssykehus HF, Ulleval
-
-
-
-
-
Gdynia, Polen, 81-384
- Synexus Polska Sp. z o.o. Oddzial w Gdyni
-
Grodzisk Mazowiecki, Polen, 05-825
- MCBK Sc lwona Czajkowska Monika Barney
-
Katowice, Polen, 40-040
- Synexus Polska Sp. z o. o. Oddizial w Katowicach.
-
Katowice, Polen, 40-084
- Clinport Tura Lipinska Dabrowski S.C.
-
Krakow, Polen, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
-
Lodz, Polen, 91-302
- Jan Zbigniew Peruga NZOZ SALUS
-
Olawa, Polen, 55-200
- Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych
-
Poznan, Polen, 60-702
- Synexus Polska Sp. z o.o Oddzial w Poznaniu
-
Pulawy, Polen, 24-100
- KO-MED Centra Kliniczne Sp. z o.o.
-
Warszawa, Polen, 01-192
- Synexus Polska Sp. z o.o. Oddzial w Warszawie
-
Wroclaw, Polen, 50-088
- Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
-
Wroclaw, Polen, 51-685
- .WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina
-
-
Lubelskie
-
Lublin, Lubelskie, Polen, 20-362
- KO-MED Centra Kliniczne LUBLIN
-
Zamosc, Lubelskie, Polen, 22-400
- KO-MED Centra Kliniczne Zamosc
-
-
Swietokrzyskie
-
Staszow, Swietokrzyskie, Polen, 28-200
- KO-MED. Centra Kliniczne Staszow
-
-
-
-
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Ponce, Puerto Rico, 00716
- Ponce School of Medicine
-
Ponce, Puerto Rico, 00717
- Cardiometabolic Research Center, Inc
-
Rio Grande, Puerto Rico, 00745
- Caparra Internal Medicine
-
-
-
-
-
Singapore, Singapore, 119228
- National University Hospital
-
Singapore, Singapore, 169609
- National Heart Centre Singapore
-
-
-
-
-
Ayr, Storbritannia, KA6 6DX
- University Hospital Ayr - Nhs Ayrshire And Arran
-
Birmingham, Storbritannia, B15 2SQ
- Synexus Midlands Clinical Research Centre
-
Hull, Storbritannia, HU3 2JZ
- Hull and East Yorkshire Hospitals NHS Trust
-
Liverpool, Storbritannia, L22 0LG
- Synexus Merseyside Clinical Research Centre
-
Manchester, Storbritannia, M15 6SX
- Synexus Manchester Clinical Research Centre
-
Swansea, Storbritannia, SA2 8PP
- Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,
-
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Berkshire
-
Reading, Berkshire, Storbritannia, RG2 0TG
- Synexus Thames Valley Clinical Research Centre
-
-
Greater Manchester
-
Salford, Greater Manchester, Storbritannia, M6 8HD
- Salford Royal NHS Foundation Trust
-
-
Lanarkshire Scotland
-
Glasgow, Lanarkshire Scotland, Storbritannia, G20 0SP
- Synexus Scotland Clinical Research Centre
-
-
Lancashire
-
Chorley, Lancashire, Storbritannia, PR7 7NA
- Synexus Lancashire Clinical Research Centre
-
-
Northumberland
-
Hexham, Northumberland, Storbritannia, NE46 1QJ
- Synexus North East Clinical Research Centre - Hexham General Hospital
-
-
Worcestershire
-
Worcester, Worcestershire, Storbritannia, WR5 1DD
- Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
-
-
-
-
-
Goteborg, Sverige, 413 45
- Clinical Trial Center (CTC)/Centrum foer klinisk proevning
-
Lessebo, Sverige, 360 50
- Vardcentralen Lessebo
-
Linkoping, Sverige, 58758
- Clinical Trials Consultants AB
-
Lund, Sverige, 222 22
- ProbarE i Lund AB
-
Lund, Sverige, 22221
- Capio Citykliniken Hjartmottagning
-
Rattvik, Sverige, 79530
- Dalecarlia Clinical Research Center
-
Stockholm, Sverige, 141 86
- Karolinska Universitetssjukhuset Huddinge
-
Stockholm, Sverige, 111 57
- Citydiabetes
-
-
-
-
-
Brno, Tsjekkia, 656 91
- Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
-
Brno, Tsjekkia, 656 91
- Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
-
Kladno, Tsjekkia, 27280
- Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
-
Kladno, Tsjekkia, 27280
- Lekarna - P-P Klinika Kladno
-
Kromeriz, Tsjekkia, 76701
- Lunacor s.r.o.
-
Olomouc, Tsjekkia, 779 00
- PreventaMed, s.r.o.
-
Olomouc, Tsjekkia, 775 20
- Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
-
Olomouc, Tsjekkia, 77520
- Lekarna Fakultni nemocnice Olomouc (pharmacy)
-
Olomouc, Tsjekkia, 779 00
- Lekarna Domovina
-
Praha 4, Tsjekkia, 140 21
- IKEM, Ustavni lekarna
-
Praha 4, Tsjekkia, 140 21
- IKEM, Oddeleni preventivni kardiologie
-
Pribram, Tsjekkia, 261 01
- BENU Lekarna
-
Pribram, Tsjekkia, 261 01
- Kardiologicka ambulance, III. Poliklinika
-
Slany, Tsjekkia, 274 01
- Nemocnice Slany, interni oddeleni
-
Slany, Tsjekkia, 274 01
- Lekarna 203-02
-
Teplice, Tsjekkia, 415 01
- AeskuLab k.s., Lipidova poradna
-
Teplice, Tsjekkia, 415 01
- Lekarna Centrum (pharmacy)
-
Trutnov, Tsjekkia, 541 01
- Dr.Max lekarna
-
-
Kralovehradecky KRAJ
-
Trutnov, Kralovehradecky KRAJ, Tsjekkia, 54101
- Kardiologicka ambulance
-
-
Vinohrady
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Praha 10, Vinohrady, Tsjekkia, 100 34
- Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: placebo
|
Subcutaneous injection every 2 weeks for 52 weeks.
|
|
Eksperimentell: Bococizumab (PF-04950615; RN316)
|
150 mg every 2 weeks, subcutaneous injection for 52 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Prosentvis endring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentvis endring fra baseline i fastende totalkolesterol (TC) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
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Grunnlinje, uke 12, 24, 52
|
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Prosentvis endring fra baseline i fastende apolipoprotein B (ApoB) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
|
Grunnlinje, uke 12, 24, 52
|
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Prosentvis endring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) etter triglyserider Cut-off større enn eller lik (>=) 200 milligram per desiliter (mg/dL) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
|
Grunnlinje, uke 12, 24, 52
|
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Prosentvis endring fra baseline i fastende høydensitetslipoproteinkolesterol (HDL-C) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
|
Grunnlinje, uke 12, 24, 52
|
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Prosentvis endring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) ved uke 24, 52: Behandlingsperiode
Tidsramme: Baseline, uke 24, 52
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Baseline, uke 24, 52
|
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Prosentvis endring fra baseline i fastende triglyserider (TG) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
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Grunnlinje, uke 12, 24, 52
|
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Prosentvis endring fra baseline i fastende apolipoprotein A-I (ApoA-I) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
|
Grunnlinje, uke 12, 24, 52
|
|
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Prosentvis endring fra baseline i fastende apolipoprotein A-II (ApoA-II) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
|
Grunnlinje, uke 12, 24, 52
|
|
|
Prosentvis endring fra baseline i fastende lipoproteinkolesterol med svært lav tetthet (VLDL-C) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
|
Grunnlinje, uke 12, 24, 52
|
|
|
Absolutt endring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) med triglyserider Cut-off på mindre enn (<) 200 milligram per desiliter (mg/dL) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
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|
Absolutt endring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) med triglyserider Cut-off større enn eller lik (>=) 200 milligram per desiliter (mg/dL) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
|
|
Absolutt endring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
|
|
Absolutt endring fra baseline i fastende totalkolesterol (TC) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
|
|
Absolutt endring fra baseline i fastende apolipoprotein B (ApoB) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
|
|
Absolutt endring fra baseline i fastende høydensitetslipoproteinkolesterol (HDL-C) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
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|
Absolutt endring fra baseline i forholdet mellom fastende totalkolesterol (TC) til høydensitetslipoproteinkolesterol (HDL-C) ved uke 12, 24 og 52
Tidsramme: Grunnlinje, uke 12, 24, 52
|
Grunnlinje, uke 12, 24, 52
|
|
|
Prosentandel av deltakere som oppnår fastende lavdensitetslipoproteinkolesterol (LDL-C) mindre enn eller lik (<=) 100 milligram per desiliter (mg/dL) ved uke 12, 24 og 52
Tidsramme: Uke 12, 24, 52
|
Uke 12, 24, 52
|
|
|
Prosentandel av deltakere som oppnår fastende lavdensitetslipoproteinkolesterol (LDL-C) mindre enn eller lik (<=) 70 milligram per desiliter (mg/dL) ved uke 12, 24 og 52
Tidsramme: Uke 12, 24, 52
|
Uke 12, 24, 52
|
|
|
Absolutt endring fra baseline i fastende ikke-høydensitetslipoproteinkolesterol (ikke HDL-C) ved uke 12
Tidsramme: Baseline, uke 12
|
Baseline, uke 12
|
|
|
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52
Tidsramme: Baseline, Week 12, 24, 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
Tidsramme: Baseline, Week 12, 24, 52
|
Baseline, Week 12, 24, 52
|
|
|
Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52
Tidsramme: Baseline, Week 12, 24, 52
|
Baseline, Week 12, 24, 52
|
|
|
Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12
Tidsramme: Baseline, Week 12
|
Baseline, Week 12
|
|
|
Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Tidsramme: Baseline, Week 12, 24, 52
|
Baseline, Week 12, 24, 52
|
|
|
Plasma Concentration Versus Time Summary of PF-04950615
Tidsramme: Week 12, 24, 52
|
Week 12, 24, 52
|
|
|
Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions
Tidsramme: Baseline up to end of study (up to 110 weeks)
|
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.
|
Baseline up to end of study (up to 110 weeks)
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
Tidsramme: Baseline up to Week 58
|
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.
|
Baseline up to Week 58
|
|
Number of Participants Who Changed Concomitant Medication During Extension Period
Tidsramme: Week 58 follow-up to Week 110
|
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.
|
Week 58 follow-up to Week 110
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period
Tidsramme: Baseline, Week 58 (follow up), 71, 84, 97, 110
|
Baseline, Week 58 (follow up), 71, 84, 97, 110
|
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Tidsramme: Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110
|
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.
|
Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.
- Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.
- Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. oktober 2014
Primær fullføring (Faktiske)
15. juli 2016
Studiet fullført (Faktiske)
10. juli 2017
Datoer for studieregistrering
Først innsendt
27. mars 2014
Først innsendt som oppfylte QC-kriteriene
27. mars 2014
Først lagt ut (Anslag)
1. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. juli 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2018
Sist bekreftet
1. juli 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B1481045
- SPIRE-LL (Annen identifikator: Alias Study Number)
- 2014-000478-20 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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