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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
746
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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
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Chicoutimi, Quebec, Canada, G7H 7K9
- Ecogene-21
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Greenfield Park, Quebec, Canada, J4V 2G8
- Viacar Recherche Clinique Inc.
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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
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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.
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Trois-Rivieres, Quebec, Canada, G8T 7A1
- C.I.C. Maurice Inc.
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Ayr, Det Forenede Kongerige, KA6 6DX
- University Hospital Ayr - Nhs Ayrshire And Arran
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Birmingham, Det Forenede Kongerige, B15 2SQ
- Synexus Midlands Clinical Research Centre
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Hull, Det Forenede Kongerige, HU3 2JZ
- Hull and East Yorkshire Hospitals NHS Trust
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Liverpool, Det Forenede Kongerige, L22 0LG
- Synexus Merseyside Clinical Research Centre
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Manchester, Det Forenede Kongerige, M15 6SX
- Synexus Manchester Clinical Research Centre
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Swansea, Det Forenede Kongerige, SA2 8PP
- Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,
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Berkshire
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Reading, Berkshire, Det Forenede Kongerige, RG2 0TG
- Synexus Thames Valley Clinical Research Centre
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Greater Manchester
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Salford, Greater Manchester, Det Forenede Kongerige, M6 8HD
- Salford Royal NHS Foundation Trust
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Lanarkshire Scotland
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Glasgow, Lanarkshire Scotland, Det Forenede Kongerige, G20 0SP
- Synexus Scotland Clinical Research Centre
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Lancashire
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Chorley, Lancashire, Det Forenede Kongerige, PR7 7NA
- Synexus Lancashire Clinical Research Centre
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Northumberland
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Hexham, Northumberland, Det Forenede Kongerige, NE46 1QJ
- Synexus North East Clinical Research Centre - Hexham General Hospital
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Worcestershire
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Worcester, Worcestershire, Det Forenede Kongerige, WR5 1DD
- Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
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Lappeenranta, Finland, 53130
- Etela-Karjalan Keskussairaala
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Turku, Finland, 20520
- Turku University Hospital
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Alabama
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Alexander City, Alabama, Forenede Stater, 35010
- Advanced Cardiovascular, LLC Research
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Auburn, Alabama, Forenede Stater, 36830
- Advanced Cardiovascular, LLC, Research
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Arizona
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Phoenix, Arizona, Forenede Stater, 85018
- Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
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Phoenix, Arizona, Forenede Stater, 85018
- Clinical Research Advantage, Inc./Family Practice Specialists, LTD
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Tucson, Arizona, Forenede Stater, 85712
- Radiant Research, Inc.
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Tucson, Arizona, Forenede Stater, 85712
- Radiant Research, Inc
-
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Lynn Institute of the Ozarks
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Little Rock, Arkansas, Forenede Stater, 72205
- The Office of Larry Watkins, MD
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California
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Los Angeles, California, Forenede Stater, 90017
- American Institute of Research
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Los Angeles, California, Forenede Stater, 90020
- IMD Medical Group
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Los Angeles, California, Forenede Stater, 90017
- lntermed Group
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Norwalk, California, Forenede Stater, 90650
- The Office of Lucita M. Cruz, M.D., Inc.
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Sacramento, California, Forenede Stater, 95825
- Superior Research, LLC
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Sacramento, California, Forenede Stater, 95831
- Superior Research ,LLC
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Santa Rosa, California, Forenede Stater, 95405
- Radiant Research, Inc.
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Tustin, California, Forenede Stater, 92780
- Orange County Research Center
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Ventura, California, Forenede Stater, 93003
- Ventura Clinical Trials
-
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Hospital
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Colorado Springs, Colorado, Forenede Stater, 80909
- Clinical Research Advantage, Inc. / Colorado Springs Family Practice
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Denver, Colorado, Forenede Stater, 80209
- Creekside Endocrine Associates, PC
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Florida
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Boca Raton, Florida, Forenede Stater, 33432
- Boca Raton Clinical Research Associates
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Boca Raton, Florida, Forenede Stater, 33432
- BRCR Medical Center, Inc.
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Brooksville, Florida, Forenede Stater, 34601
- Meridien Research
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Coral Gables, Florida, Forenede Stater, 33134
- Linfritz Research Institute Inc.
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Fort Lauderdale, Florida, Forenede Stater, 33312
- Florida Health Center
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Hialeah, Florida, Forenede Stater, 33012
- Indago Research & Health Center, Inc.
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Hialeah, Florida, Forenede Stater, 33012
- Health Care Family Rehab & Research Center
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Miami, Florida, Forenede Stater, 33144
- Elite Clinical Research
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Miami, Florida, Forenede Stater, 33130
- Sunrise Research Institute, Inc
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Miami, Florida, Forenede Stater, 33133
- Prestige Clinical Research Center, Inc.
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Miami, Florida, Forenede Stater, 33155
- Advanced Clinical Research of Miami
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Miami, Florida, Forenede Stater, 33135
- Suncoast Research Group, LLD
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Miami, Florida, Forenede Stater, 33162
- The Research Specialists of Florida, Inc.
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Miami, Florida, Forenede Stater, 33165
- Columbus Clinical Services, LLC
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Miami Beach, Florida, Forenede Stater, 33140
- NewPhase Clinical Trials, Corp.
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Miami Lakes, Florida, Forenede Stater, 33014
- Panax Clinical Research
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Miami Lakes, Florida, Forenede Stater, 33016
- Precision Research Organization
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Miramar, Florida, Forenede Stater, 33025
- First Quality
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Ocala, Florida, Forenede Stater, 34471
- Renstar Medical Research
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Ocala, Florida, Forenede Stater, 34471
- American Family Medical
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Pembroke Pines, Florida, Forenede Stater, 33026
- Pines Care Research Center, LLC
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Pembroke Pines, Florida, Forenede Stater, 33029
- DBC Research USA
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Pembroke Pines, Florida, Forenede Stater, 33026
- Andres Patron, D.O.P.A.
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Port Orange, Florida, Forenede Stater, 32129
- Accord Clinical Research, LLC
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Port Orange, Florida, Forenede Stater, 32127
- Progressive Medical Research
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Saint Augustine, Florida, Forenede Stater, 32086
- East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
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Saint Augustine, Florida, Forenede Stater, 32086
- East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
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Saint Petersburg, Florida, Forenede Stater, 33709
- Meridien Research
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Sarasota, Florida, Forenede Stater, 34239
- Cardiovascular Center of Sarasota
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Tampa, Florida, Forenede Stater, 33634
- Meridien Research
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Idaho
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Boise, Idaho, Forenede Stater, 83704
- Northwest Clinical Trials, Inc.
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Indiana
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Avon, Indiana, Forenede Stater, 46123
- American Health Network of Indiana, LLC
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Kansas
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Augusta, Kansas, Forenede Stater, 67010
- Heartland Research Associates, LLC
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Wichita, Kansas, Forenede Stater, 67205
- Heartland Research Associates, LLC
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Wichita, Kansas, Forenede Stater, 67207
- Heartland Research Associates, LLC
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Wichita, Kansas, Forenede Stater, 67205
- Northwest Family Physicians
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70601
- Imperial Health, LLP
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Metairie, Louisiana, Forenede Stater, 70006
- Crescent City Clinical Research Center, LLC
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Monroe, Louisiana, Forenede Stater, 71201
- Clinical Trials of America LA
-
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Maryland
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Bethesda, Maryland, Forenede Stater, 208174
- Bethesda Health Research
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Elkridge, Maryland, Forenede Stater, 21075
- Centennial Medical Group
-
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Michigan
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Flint, Michigan, Forenede Stater, 48532
- McLaren Flint
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Minnesota
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Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Heart & Vascular Center @ St. Cloud Hospital
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Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Heart & Vascular Center at St. Cloud Hospital
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Mississippi
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Picayune, Mississippi, Forenede Stater, 39466
- Riser Medical Research
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Missouri
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Saint Louis, Missouri, Forenede Stater
- Washington University School of Medicine
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University, The Center for Advanced Medicine
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Nebraska
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Fremont, Nebraska, Forenede Stater, 68025
- Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
-
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New Hampshire
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Portsmouth, New Hampshire, Forenede Stater, 03801
- ActivMed Practices & Research, Inc.
-
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Albuquerque Clinical Trials, Inc.
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North Carolina
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Greenville, North Carolina, Forenede Stater, 27834
- Physician's East Endocrinology
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Greenville, North Carolina, Forenede Stater, 27834
- Physician's East, PA
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Greenville, North Carolina, Forenede Stater, 27834
- Physician's East P.A.
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Hickory, North Carolina, Forenede Stater, 28601
- Clinical Trials of America, Inc.
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Hickory, North Carolina, Forenede Stater, 28602
- PMG Research of Hickory
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Hickory, North Carolina, Forenede Stater, 28601
- Catawba Valley Medical Group, Inc.
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Raleigh, North Carolina, Forenede Stater, 27612
- Wake Research Associates, LLC
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Raleigh, North Carolina, Forenede Stater, 27612
- Wake Internal Medicine Consultants, Inc.
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Ohio
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Dayton, Ohio, Forenede Stater, 45419
- PriMed Clinical Research
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Perrysburg, Ohio, Forenede Stater, 43551
- Office of Daniel G. Williams, MD
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73135
- South Oklahoma Heart Research, LLC
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Tulsa, Oklahoma, Forenede Stater, 74136
- Castlerock Clinical Research Consultants,LLC
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Pennsylvania
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Harleysville, Pennsylvania, Forenede Stater, 19438
- Harleysville Medical Associates
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Wyomissing, Pennsylvania, Forenede Stater, 19610
- Berks Cardiologists, Ltd.
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29407
- Medical Research South, LLC
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Columbia, South Carolina, Forenede Stater, 29204
- Ellipsis Research Group, LLC
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Research
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Stern Cardiovascular Foundation, Inc
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Jackson, Tennessee, Forenede Stater, 38301
- Research Associates Of Jackson
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Jackson, Tennessee, Forenede Stater, 38301
- Apex Cardiology
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Knoxville, Tennessee, Forenede Stater, 37912
- PMG Research, Inc d/b/a PMG Research of Knoxville
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Texas
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Carrollton, Texas, Forenede Stater, 75006
- Punzi Medical Center
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Houston, Texas, Forenede Stater, 77036
- Juno Research, LLC
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Houston, Texas, Forenede Stater, 77090
- Office of Michelle Zaniewski MD., PA.
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Houston, Texas, Forenede Stater, 77081
- Gulf Coast Medical Research,LLC
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Katy, Texas, Forenede Stater, 77450
- Juno Research, LLC
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Missouri City, Texas, Forenede Stater, 77459
- Gulf Coast Medical Research, LLC
-
Plano, Texas, Forenede Stater, 75093
- Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
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San Antonio, Texas, Forenede Stater, 78205
- Clinical Trials of Texas, Inc.
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Sugar Land, Texas, Forenede Stater, 77478
- Gulf Coast Medical Research, LLC
-
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Utah
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Orem, Utah, Forenede Stater, 84058
- Aspen Clinical Research
-
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Virginia
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Arlington, Virginia, Forenede Stater, 22207
- Millennium Clinical Trials, LLC
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Norfolk, Virginia, Forenede Stater, 23502
- National Clinical Research-Norfolk, Inc.
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Washington
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Port Orchard, Washington, Forenede Stater, 98366
- Sound Medical Research
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Port Orchard, Washington, Forenede Stater, 98366
- Sound Health Care Center
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Walla Walla, Washington, Forenede Stater, 99362
- Walla Walla Clinic
-
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Wisconsin
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Kenosha, Wisconsin, Forenede Stater, 53142
- Clinical Investigation Specialists, Inc.
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Manitowoc, Wisconsin, Forenede Stater, 54220
- HFM Heart and Vascular Center/Holy Family Memorial, Inc
-
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-
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Apeldoorn, Holland, 7334 DZ
- Gelre Hospitals
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Eindhoven, Holland, 5611 NV
- Andromed Eindhoven
-
Enschede, Holland, 7513 ER
- Medisch Spectrum Twente
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Gorinchem, Holland, 4204 AA
- Beatrix Hospital
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Groningen, Holland, 9728 NT
- Martini Ziekenhuis
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Heerlen, Holland, 6419 PC
- Zuyderland Medisch Centrum
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Rotterdam, Holland, 3083AN
- Ikazia Hospital
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Rotterdam, Holland, 3021 HC
- Andro Medical Research B.V.
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Sneek, Holland, 8601 ZR
- D&A Research and Genetics
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Tilburg, Holland, 5022 GC
- St. Elisabeth Hospital
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Utrecht, Holland, 3584 CX
- University Medical Center Utrecht
-
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ER
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Enschede, ER, Holland, 7513
- Medisch Spectrum Twente
-
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North Holland
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Amsterdam, North Holland, Holland, 1061 AE
- St Lucas Andreas Hospital
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-
-
-
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Busan, Korea, Republikken, 49201
- Dong-A University Hospital
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Seoul, Korea, Republikken, 137-701
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Korea, Republikken, 431-796
- Sacred Heart Hospital-Hallym University
-
Guri-si, Gyeonggi-do, Korea, Republikken, 11923
- Hanyang University Guri Hospital
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-
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Honefoss, Norge, 3515
- Ossum Gronert Legetjeneste AS
-
Oslo, Norge, 0373
- Oslo Universitetssykehus HF
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Oslo, Norge, 0424
- Oslo Universitetssykehus HF, Ulleval
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-
-
-
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Gdynia, Polen, 81-384
- Synexus Polska Sp. z o.o. Oddzial w Gdyni
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Grodzisk Mazowiecki, Polen, 05-825
- MCBK Sc lwona Czajkowska Monika Barney
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Katowice, Polen, 40-040
- Synexus Polska Sp. z o. o. Oddizial w Katowicach.
-
Katowice, Polen, 40-084
- Clinport Tura Lipinska Dabrowski S.C.
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Krakow, Polen, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
-
Lodz, Polen, 91-302
- Jan Zbigniew Peruga NZOZ SALUS
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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
-
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Lubelskie
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Lublin, Lubelskie, Polen, 20-362
- KO-MED Centra Kliniczne LUBLIN
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Zamosc, Lubelskie, Polen, 22-400
- KO-MED Centra Kliniczne Zamosc
-
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Swietokrzyskie
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Staszow, Swietokrzyskie, Polen, 28-200
- KO-MED. Centra Kliniczne Staszow
-
-
-
-
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Ponce, Puerto Rico, 00716
- Ponce School of Medicine
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Ponce, Puerto Rico, 00717
- Cardiometabolic Research Center, Inc
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Rio Grande, Puerto Rico, 00745
- Caparra Internal Medicine
-
-
-
-
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Singapore, Singapore, 119228
- National University Hospital
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Singapore, Singapore, 169609
- National Heart Centre Singapore
-
-
-
-
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Goteborg, Sverige, 413 45
- Clinical Trial Center (CTC)/Centrum foer klinisk proevning
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Lessebo, Sverige, 360 50
- Vardcentralen Lessebo
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Linkoping, Sverige, 58758
- Clinical Trials Consultants AB
-
Lund, Sverige, 222 22
- ProbarE i Lund AB
-
Lund, Sverige, 22221
- Capio Citykliniken Hjartmottagning
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Rattvik, Sverige, 79530
- Dalecarlia Clinical Research Center
-
Stockholm, Sverige, 141 86
- Karolinska Universitetssjukhuset Huddinge
-
Stockholm, Sverige, 111 57
- Citydiabetes
-
-
-
-
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Brno, Tjekkiet, 656 91
- Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
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Brno, Tjekkiet, 656 91
- Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
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Kladno, Tjekkiet, 27280
- Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
-
Kladno, Tjekkiet, 27280
- Lekarna - P-P Klinika Kladno
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Kromeriz, Tjekkiet, 76701
- Lunacor s.r.o.
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Olomouc, Tjekkiet, 779 00
- PreventaMed, s.r.o.
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Olomouc, Tjekkiet, 775 20
- Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
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Olomouc, Tjekkiet, 77520
- Lekarna Fakultni nemocnice Olomouc (pharmacy)
-
Olomouc, Tjekkiet, 779 00
- Lekarna Domovina
-
Praha 4, Tjekkiet, 140 21
- IKEM, Ustavni lekarna
-
Praha 4, Tjekkiet, 140 21
- IKEM, Oddeleni preventivni kardiologie
-
Pribram, Tjekkiet, 261 01
- BENU Lekarna
-
Pribram, Tjekkiet, 261 01
- Kardiologicka ambulance, III. Poliklinika
-
Slany, Tjekkiet, 274 01
- Nemocnice Slany, interni oddeleni
-
Slany, Tjekkiet, 274 01
- Lekarna 203-02
-
Teplice, Tjekkiet, 415 01
- AeskuLab k.s., Lipidova poradna
-
Teplice, Tjekkiet, 415 01
- Lekarna Centrum (pharmacy)
-
Trutnov, Tjekkiet, 541 01
- Dr.Max lekarna
-
-
Kralovehradecky KRAJ
-
Trutnov, Kralovehradecky KRAJ, Tjekkiet, 54101
- Kardiologicka ambulance
-
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Vinohrady
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Praha 10, Vinohrady, Tjekkiet, 100 34
- Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: placebo
|
Subcutaneous injection every 2 weeks for 52 weeks.
|
|
Eksperimentel: Bococizumab (PF-04950615; RN316)
|
150 mg every 2 weeks, subcutaneous injection for 52 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Procentvis ændring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) i uge 12
Tidsramme: Baseline, uge 12
|
Baseline, uge 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Procentvis ændring fra baseline i fastende totalkolesterol (TC) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procentvis ændring fra baseline i fastende apolipoprotein B (ApoB) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procent ændring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) med triglycerider afskæring på større end eller lig med (>=) 200 milligram pr. deciliter (mg/dL) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procentvis ændring fra baseline i fastende højdensitetslipoproteinkolesterol (HDL-C) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procentvis ændring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) i uge 24, 52: Behandlingsperiode
Tidsramme: Baseline, uge 24, 52
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Baseline, uge 24, 52
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Procent ændring fra baseline i fastende triglycerider (TG) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procent ændring fra baseline i fastende apolipoprotein A-I (ApoA-I) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procent ændring fra baseline i fastende apolipoprotein A-II (ApoA-II) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procentvis ændring fra baseline i fastende meget lavdensitetslipoproteinkolesterol (VLDL-C) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Absolut ændring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) ved triglycerider afskæring på mindre end (<) 200 milligram pr. deciliter (mg/dL) i uge 12
Tidsramme: Baseline, uge 12
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Baseline, uge 12
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Absolut ændring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) ved triglycerider Cut-off større end eller lig med (>=) 200 milligram pr. deciliter (mg/dL) i uge 12
Tidsramme: Baseline, uge 12
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Baseline, uge 12
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Absolut ændring fra baseline i fastende lavdensitetslipoproteinkolesterol (LDL-C) i uge 12
Tidsramme: Baseline, uge 12
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Baseline, uge 12
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Absolut ændring fra baseline i fastende totalkolesterol (TC) i uge 12
Tidsramme: Baseline, uge 12
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Baseline, uge 12
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Absolut ændring fra baseline i fastende apolipoprotein B (ApoB) i uge 12
Tidsramme: Baseline, uge 12
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Baseline, uge 12
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Absolut ændring fra baseline i fastende højdensitetslipoproteinkolesterol (HDL-C) i uge 12
Tidsramme: Baseline, uge 12
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Baseline, uge 12
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Absolut ændring fra baseline i forholdet mellem fastende totalkolesterol (TC) til højdensitetslipoproteinkolesterol (HDL-C) i uge 12, 24 og 52
Tidsramme: Baseline, uge 12, 24, 52
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Baseline, uge 12, 24, 52
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Procentdel af deltagere, der opnår fastende lavdensitetslipoproteinkolesterol (LDL-C) mindre end eller lig med (<=) 100 milligram pr. deciliter (mg/dL) i uge 12, 24 og 52
Tidsramme: Uge 12, 24, 52
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Uge 12, 24, 52
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Procentdel af deltagere, der opnår fastende lavdensitetslipoproteinkolesterol (LDL-C) mindre end eller lig med (<=) 70 milligram pr. deciliter (mg/dL) i uge 12, 24 og 52
Tidsramme: Uge 12, 24, 52
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Uge 12, 24, 52
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Absolut ændring fra baseline i fastende ikke-højdensitetslipoproteinkolesterol (ikke HDL-C) i uge 12
Tidsramme: Baseline, uge 12
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Baseline, uge 12
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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
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Baseline, Week 12, 24, 52
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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
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Baseline, Week 12, 24, 52
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Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52
Tidsramme: Baseline, Week 12, 24, 52
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Baseline, Week 12, 24, 52
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Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12
Tidsramme: Baseline, Week 12
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Baseline, Week 12
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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
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Baseline, Week 12, 24, 52
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Plasma Concentration Versus Time Summary of PF-04950615
Tidsramme: Week 12, 24, 52
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Week 12, 24, 52
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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)
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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.
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Baseline up to end of study (up to 110 weeks)
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Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
Tidsramme: Baseline up to Week 58
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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.
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Baseline up to Week 58
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Number of Participants Who Changed Concomitant Medication During Extension Period
Tidsramme: Week 58 follow-up to Week 110
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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.
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Week 58 follow-up to Week 110
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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
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Baseline, Week 58 (follow up), 71, 84, 97, 110
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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
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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.
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Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. oktober 2014
Primær færdiggørelse (Faktiske)
15. juli 2016
Studieafslutning (Faktiske)
10. juli 2017
Datoer for studieregistrering
Først indsendt
27. marts 2014
Først indsendt, der opfyldte QC-kriterier
27. marts 2014
Først opslået (Skøn)
1. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B1481045
- SPIRE-LL (Anden identifikator: Alias Study Number)
- 2014-000478-20 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Bococizumab (PF-04950615; RN316)
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PfizerAfsluttetHyperkolesterolæmiForenede Stater
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PfizerAfsluttetHyperlipidæmiForenede Stater, Canada
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PfizerAfsluttetHyperlipidæmiKorea, Republikken, Forenede Stater, Australien, Tyskland, Polen, Canada, Italien, Hong Kong, Tjekkiet
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PfizerAfsluttetHyperkolesterolæmiForenede Stater
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PfizerAfsluttetKardiovaskulær sygdomFinland, Forenede Stater, Holland, Spanien, Korea, Republikken, Kina, Israel, Belgien, Tyskland, Australien, Tjekkiet, Taiwan, Danmark, Det Forenede Kongerige, Ungarn, Polen, Frankrig, Mexico, Kalkun, Canada, New Zealand, Colombia, S... og mere
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PfizerAfsluttetKardiovaskulær sygdomForenede Stater, Finland, Holland, Spanien, Belgien, Tyskland, Tjekkiet, Schweiz, Danmark, Australien, Det Forenede Kongerige, Korea, Republikken, Ungarn, Israel, Polen, Taiwan, Mexico, Kalkun, Irland, Canada, New Zealand, Sydafrika, Brasilie... og mere
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PfizerAfsluttetHyperlipidæmiForenede Stater, Spanien, Taiwan, Det Forenede Kongerige, Canada, Mexico, Frankrig, Ungarn, Litauen, Colombia, Rumænien, Den Russiske Føderation
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PfizerAfsluttetHeterozygot familiær hyperkolesterolæmiCanada, Holland, Det Forenede Kongerige, Forenede Stater, Spanien, Polen, Finland, Norge, Sydafrika, Italien, Bulgarien
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PfizerAfsluttet
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PfizerAfsluttetSikkerhed og tolerabilitet af flere doser af PF-04950615 (RN316) hos personer med hyperkolesterolæmiDyslipidæmi | HyperkolesterolæmiForenede Stater