Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia (OSLER-2)
20. mai 2019 oppdatert av: Amgen
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
3681
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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New South Wales
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Camperdown, New South Wales, Australia, 2015
- Research Site
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Maroubra, New South Wales, Australia, 2035
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Sydney, New South Wales, Australia, 2022
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Sydney, New South Wales, Australia, 2010
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Queensland
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Auchenflower, Queensland, Australia, 4066
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Carina Heights, Queensland, Australia, 4152
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Sherwood, Queensland, Australia, 4075
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Woolloongabba, Queensland, Australia, 4102
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South Australia
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Ashford, South Australia, Australia, 5035
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Fullarton, South Australia, Australia, 5063
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Victoria
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Heidelberg Heights, Victoria, Australia, 3081
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Melbourne, Victoria, Australia, 3004
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Western Australia
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Perth, Western Australia, Australia, 6000
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Anthée, Belgia, 5520
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Blankenberge, Belgia, 8370
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Bruxelles, Belgia, 1200
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Bruxelles, Belgia, 1080
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Chênée, Belgia, 4032
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Gent, Belgia, 9000
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Gozee, Belgia, 6534
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Gribomont, Belgia, 6887
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Halen, Belgia, 3545
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Ham, Belgia, 3945
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Hasselt, Belgia, 3500
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La Louvière, Belgia, 7100
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Linkebeek, Belgia, 1630
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Oostende, Belgia, 8400
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Tessenderlo, Belgia, 3980
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Tremelo, Belgia, 3120
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Vilvoorde, Belgia, 1800
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Quebec, Canada, G1V 4M6
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British Columbia
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Burnaby, British Columbia, Canada, V5G 1T4
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Kelowna, British Columbia, Canada, V1Y 1V6
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Surrey, British Columbia, Canada, V3V 1N1
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Vancouver, British Columbia, Canada, V6Z 1Y6
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Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
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Ontario
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Cambridge, Ontario, Canada, N1R 6V6
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Hamilton, Ontario, Canada, L8L 2X2
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London, Ontario, Canada, N5W 6A2
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London, Ontario, Canada, N6A 5K8
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Newmarket, Ontario, Canada, L3Y 5G8
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Oshawa, Ontario, Canada, L1J 2K1
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Peterborough, Ontario, Canada, K9J 0B2
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Sarnia, Ontario, Canada, N7T 4X3
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Toronto, Ontario, Canada, M9V 4B4
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Toronto, Ontario, Canada, M9W 4L6
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Toronto, Ontario, Canada, M8V 3X8
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Woodstock, Ontario, Canada, N4S 5P5
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
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Granby, Quebec, Canada, J2G 8Z9
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Greenfield Park, Quebec, Canada, J4V 2G8
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Lachine, Quebec, Canada, H8S 2E4
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H4N 2W2
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Montreal, Quebec, Canada, H2W 1R7
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Pointe-Claire, Quebec, Canada, H9R 3J1
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Aalborg, Danmark, 9000
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Aarhus N, Danmark, 8200
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Ballerup, Danmark, 2750
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Glostrup, Danmark, 2600
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Vejle, Danmark, 7100
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Barnaul, Den russiske føderasjonen, 656055
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Kemerovo, Den russiske føderasjonen, 650002
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Moscow, Den russiske føderasjonen, 121552
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Novosibirsk, Den russiske føderasjonen, 630047
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Saint Petersburg, Den russiske føderasjonen, 197022
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Saratov, Den russiske føderasjonen, 410054
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Alabama
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Birmingham, Alabama, Forente stater, 35294
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Birmingham, Alabama, Forente stater, 35216
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Arizona
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Chandler, Arizona, Forente stater, 85224
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Phoenix, Arizona, Forente stater, 85020
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Tucson, Arizona, Forente stater, 85712
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
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California
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Beverly Hills, California, Forente stater, 90211
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Carmichael, California, Forente stater, 95608
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Encinitas, California, Forente stater, 92024
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Huntington Beach, California, Forente stater, 92648
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Los Angeles, California, Forente stater, 90048
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Mission Viejo, California, Forente stater, 92691
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Newport Beach, California, Forente stater, 92663
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San Diego, California, Forente stater, 92111
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Santa Ana, California, Forente stater, 92705
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Santa Rosa, California, Forente stater, 95405
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Spring Valley, California, Forente stater, 91978
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Thousand Oaks, California, Forente stater, 91360
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Torrance, California, Forente stater, 90509
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Tustin, California, Forente stater, 92780
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Ventura, California, Forente stater, 93003
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Colorado
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Littleton, Colorado, Forente stater, 80120
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Florida
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Daytona Beach, Florida, Forente stater, 32117
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DeLand, Florida, Forente stater, 32720
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Jacksonville, Florida, Forente stater, 32216
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Melbourne, Florida, Forente stater, 32901
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Miami, Florida, Forente stater, 33173
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Miami, Florida, Forente stater, 33144
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Ponte Vedra, Florida, Forente stater, 32081
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Port Charlotte, Florida, Forente stater, 33952
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Sanford, Florida, Forente stater, 32771
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Georgia
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Atlanta, Georgia, Forente stater, 30328
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Atlanta, Georgia, Forente stater, 30338
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Atlanta, Georgia, Forente stater, 30342
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Gainesville, Georgia, Forente stater, 30501
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Savannah, Georgia, Forente stater, 31406
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Illinois
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Chicago, Illinois, Forente stater, 60654
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Sterling, Illinois, Forente stater, 61081
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Indiana
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Indianapolis, Indiana, Forente stater, 46260
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Munster, Indiana, Forente stater, 46321
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Iowa
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Iowa City, Iowa, Forente stater, 52242
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Kansas
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Kansas City, Kansas, Forente stater, 66160
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Kentucky
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Lexington, Kentucky, Forente stater, 40504
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Louisville, Kentucky, Forente stater, 40213
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Louisiana
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Monroe, Louisiana, Forente stater, 71201
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Maine
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Auburn, Maine, Forente stater, 04210
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Bangor, Maine, Forente stater, 04401
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Portland, Maine, Forente stater, 04101
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Maryland
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Bethesda, Maryland, Forente stater, 20817
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Columbia, Maryland, Forente stater, 21045
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Towson, Maryland, Forente stater, 21204
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Massachusetts
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Ayer, Massachusetts, Forente stater, 01432
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Quincy, Massachusetts, Forente stater, 02169
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Michigan
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Ypsilanti, Michigan, Forente stater, 48197
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Minnesota
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Edina, Minnesota, Forente stater, 55435
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Mississippi
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Olive Branch, Mississippi, Forente stater, 38654
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Tupelo, Mississippi, Forente stater, 38801
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Missouri
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Saint Louis, Missouri, Forente stater, 63110
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Nevada
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Henderson, Nevada, Forente stater, 89052
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Las Vegas, Nevada, Forente stater, 89148
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New York
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Endwell, New York, Forente stater, 13760
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Manlius, New York, Forente stater, 13104
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New Windsor, New York, Forente stater, 12553
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New York, New York, Forente stater, 10029
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Rochester, New York, Forente stater, 14609
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Williamsville, New York, Forente stater, 14221
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North Carolina
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Raleigh, North Carolina, Forente stater, 27609
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Raleigh, North Carolina, Forente stater, 27612
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Winston-Salem, North Carolina, Forente stater, 27103
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North Dakota
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Fargo, North Dakota, Forente stater, 58103
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Ohio
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Akron, Ohio, Forente stater, 44311
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Cadiz, Ohio, Forente stater, 43907
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Canton, Ohio, Forente stater, 44710
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Cincinnati, Ohio, Forente stater, 45236
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Cincinnati, Ohio, Forente stater, 45219
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Cincinnati, Ohio, Forente stater, 45227
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Cleveland, Ohio, Forente stater, 44195
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Dayton, Ohio, Forente stater, 45414
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Mansfield, Ohio, Forente stater, 44906
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Marion, Ohio, Forente stater, 43302
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Sandusky, Ohio, Forente stater, 44870
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Oklahoma
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Norman, Oklahoma, Forente stater, 73069
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Oklahoma City, Oklahoma, Forente stater, 73103
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Oregon
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Hillsboro, Oregon, Forente stater, 97123
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Pennsylvania
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Duncansville, Pennsylvania, Forente stater, 16635
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Lansdale, Pennsylvania, Forente stater, 19446
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Pittsburgh, Pennsylvania, Forente stater, 15216
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York, Pennsylvania, Forente stater, 17405
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South Carolina
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Anderson, South Carolina, Forente stater, 29621
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Charleston, South Carolina, Forente stater, 29425
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Mount Pleasant, South Carolina, Forente stater, 29464
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South Dakota
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Rapid City, South Dakota, Forente stater, 57702
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Rapid City, South Dakota, Forente stater, 57701
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Tennessee
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Jackson, Tennessee, Forente stater, 38305
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Nashville, Tennessee, Forente stater, 37203
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Texas
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Austin, Texas, Forente stater, 78731
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Dallas, Texas, Forente stater, 75231
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Dallas, Texas, Forente stater, 75230
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Houston, Texas, Forente stater, 77030
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Houston, Texas, Forente stater, 77074
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San Antonio, Texas, Forente stater, 78229
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Virginia
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Norfolk, Virginia, Forente stater, 23502
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Richmond, Virginia, Forente stater, 23294
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Suffolk, Virginia, Forente stater, 23435
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Washington
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Renton, Washington, Forente stater, 98057
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Seattle, Washington, Forente stater, 98104
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Tacoma, Washington, Forente stater, 98405
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Brest Cedex 2, Frankrike, 29200
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Bron, Frankrike, 69677
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Caen Cedex 9, Frankrike, 14033
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Dijon, Frankrike, 21034
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Montpellier cedex 05, Frankrike, 34295
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Nantes Cedex 1, Frankrike, 44093
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Paris Cedex 12, Frankrike, 75571
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Paris Cedex 13, Frankrike, 75651
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Vénissieux, Frankrike, 69200
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Bologna, Italia, 40138
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Cagliari, Italia, 09134
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Chieti, Italia, 66100
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Cinisello Balsamo (MI), Italia, 20092
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Ferrara, Italia, 44124
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Milano, Italia, 20162
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Napoli, Italia, 80131
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Padova, Italia, 35128
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Perugia, Italia, 06129
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Pisa, Italia, 56124
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Pisa, Italia, 56100
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Trieste, Italia, 34149
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Chiba
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Noda-shi, Chiba, Japan, 278-0004
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 810-0014
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Fukuoka-shi, Fukuoka, Japan, 810-0066
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Fukuoka-shi, Fukuoka, Japan, 819-8551
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Kitakyusyu-shi, Fukuoka, Japan, 807-0856
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Fukushima
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Koriyama-shi, Fukushima, Japan, 963-0209
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Koriyama-shi, Fukushima, Japan, 963-8026
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Koriyama-shi, Fukushima, Japan, 963-8041
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Koriyama-shi, Fukushima, Japan, 963-8832
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Koriyama-shi, Fukushima, Japan, 963-8862
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Gunma
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Maebashi-shi, Gunma, Japan, 371-0022
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Takasaki-shi, Gunma, Japan, 370-3524
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Hokkaido
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Sapporo-shi, Hokkaido, Japan, 060-0063
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Sapporo-shi, Hokkaido, Japan, 003-0026
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Sapporo-shi, Hokkaido, Japan, 003-0825
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Ibaraki
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Tsuchiura-shi, Ibaraki, Japan, 300-0047
- Research Site
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Iwate
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Morioka-shi, Iwate, Japan, 020-0066
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Kagawa
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Takamatsu-shi, Kagawa, Japan, 760-0018
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Takamatsu-shi, Kagawa, Japan, 760-0076
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Kanagawa
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Yokohama-shi, Kanagawa, Japan, 231-0023
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Kyoto
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Kyoto-shi, Kyoto, Japan, 615-8125
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Miyagi
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Sendai-shi, Miyagi, Japan, 983-0039
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Sendai-shi, Miyagi, Japan, 983-0835
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Sendai-shi, Miyagi, Japan, 989-3122
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Okinawa
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Tomigusuku-shi, Okinawa, Japan, 901-0243
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Osaka
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Ibaraki-shi, Osaka, Japan, 567-0876
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Toyonaka-shi, Osaka, Japan, 560-0082
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Saitama
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Koshigaya-shi, Saitama, Japan, 343-0828
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Niiza-shi, Saitama, Japan, 352-0014
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Tokyo
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Arakawa-ku, Tokyo, Japan, 116-0002
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Chiyoda-ku, Tokyo, Japan, 101-0041
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Chofu-shi, Tokyo, Japan, 182-0006
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Edogawa-ku, Tokyo, Japan, 133-0061
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Hachioji-shi, Tokyo, Japan, 192-0046
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Katsushika-ku, Tokyo, Japan, 124-0024
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Koto-ku, Tokyo, Japan, 135-0011
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Minato-ku, Tokyo, Japan, 108-0075
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Minato-ku, Tokyo, Japan, 105-7390
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Ota-ku, Tokyo, Japan, 144-0034
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Setagaya-ku, Tokyo, Japan, 155-0031
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Shibuya-ku, Tokyo, Japan, 150-0012
- Research Site
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Shinagawa-ku, Tokyo, Japan, 140-0011
- Research Site
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Shinagawa-ku, Tokyo, Japan, 141-0001
- Research Site
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Shinagawa-ku, Tokyo, Japan, 141-6003
- Research Site
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Shinagawa-ku, Tokyo, Japan, 142-0053
- Research Site
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Toshima-ku, Tokyo, Japan, 171-0021
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Seoul, Korea, Republikken, 135-710
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Seoul, Korea, Republikken, 120-752
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Amsterdam, Nederland, 1105 AZ
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Den Helder, Nederland, 1782 GZ
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Groningen, Nederland, 9713 GZ
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Groningen, Nederland, 9728 NT
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Hoogeveen, Nederland, 7909 AA
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Hoorn, Nederland, 1625 HV
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Nijmegen, Nederland, 6525 EZ
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Rotterdam, Nederland, 3045 PM
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Tilburg, Nederland, 5022 GC
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Utrecht, Nederland, 3584 CX
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Waalwijk, Nederland, 5141 BM
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Zwijndrecht, Nederland, 3331 LZ
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Christchurch, New Zealand, 8011
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Oslo, Norge, 0373
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Ålesund, Norge, 6003
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Lodz, Polen, 91-078
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Madrid, Spania, 28040
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Madrid, Spania, 28007
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Madrid, Spania, 28029
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Andalucía
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Cordoba, Andalucía, Spania, 14004
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Aragón
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Zaragoza, Aragón, Spania, 50009
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Cataluña
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L'Hospitalet de Llobregat, Cataluña, Spania, 08907
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Reus, Cataluña, Spania, 43204
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Birmingham, Storbritannia, B15 2TH
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Birmingham, Storbritannia, B15 2SQ
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Blackpool, Storbritannia, FY3 7EN
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Cardiff, Storbritannia, CF14 5GJ
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Chesterfield, Storbritannia, S40 4AA
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Chorley, Storbritannia, PR7 7NA
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Coventry, Storbritannia, CV2 2DX
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Doncaster, Storbritannia, DN9 1EP
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Glasgow, Storbritannia, G20 0SP
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Glasgow, Storbritannia, G12 8TA
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Glasgow, Storbritannia, G45 9AW
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Liverpool, Storbritannia, L7 8XP
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Liverpool, Storbritannia, L22 0LG
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London, Storbritannia, W6 8RF
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London, Storbritannia, SE1 7EH
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London, Storbritannia, NW3 2QG
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Manchester, Storbritannia, M15 6SX
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Manchester, Storbritannia, M13 9WL
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Newcastle upon Tyne, Storbritannia, NE1 4LP
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Reading, Storbritannia, RG2 0TG
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Telford, Storbritannia, TF1 6TF
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Wakefield, Storbritannia, WF1 4DG
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West Bromwich, Storbritannia, B71 4HJ
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Whitby, Storbritannia, YO21 1SD
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Bellinzona, Sveits, 6500
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Geneva 14, Sveits, 1211
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Lausanne, Sveits, 1011
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Lugano, Sveits, 6900
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Muensterlingen, Sveits, 8596
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Reinach, Sveits, 4153
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St. Gallen, Sveits, 9007
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Zurich, Sveits, 8063
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Zurich, Sveits, 8091
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Göteborg, Sverige, 413 45
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Lund, Sverige, 222 21
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Stockholm, Sverige, 141 86
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Stockholm, Sverige, 171 45
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Stockholm, Sverige, 111 57
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Uddevalla, Sverige, 451 50
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Örebro, Sverige, 701 46
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Bloemfontein, Sør-Afrika, 9301
- Research Site
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Gauteng
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Centurion, Gauteng, Sør-Afrika, 0157
- Research Site
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Johannesburg, Gauteng, Sør-Afrika, 2193
- Research Site
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Midrand, Gauteng, Sør-Afrika, 1685
- Research Site
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Sunninghill, Gauteng, Sør-Afrika, 2157
- Research Site
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KwaZulu-Natal
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Amanzimtoti, KwaZulu-Natal, Sør-Afrika, 4126
- Research Site
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Western Cape
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Observatory, Western Cape, Sør-Afrika, 7925
- Research Site
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Paarl, Western Cape, Sør-Afrika, 7646
- Research Site
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Parow, Western Cape, Sør-Afrika, 7505
- Research Site
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Somerset West, Western Cape, Sør-Afrika, 7130
- Research Site
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Kaohsiung, Taiwan, 83301
- Research Site
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Taipei, Taiwan, 100
- Research Site
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Brno, Tsjekkia, 602 00
- Research Site
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Brno, Tsjekkia, 603 00
- Research Site
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Chomutov, Tsjekkia, 430 02
- Research Site
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Hradec Kralove, Tsjekkia, 500 05
- Research Site
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Kladno, Tsjekkia, 272 01
- Research Site
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Litomerice, Tsjekkia, 412 01
- Research Site
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Moravske Budejovice, Tsjekkia, 676 02
- Research Site
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Olomouc, Tsjekkia, 775 20
- Research Site
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Pardubice, Tsjekkia, 530 02
- Research Site
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Plzen, Tsjekkia, 305 99
- Research Site
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Praha 2, Tsjekkia, 128 08
- Research Site
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Praha 3, Tsjekkia, 130 00
- Research Site
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Praha 4, Tsjekkia, 140 21
- Research Site
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Praha 5, Tsjekkia, 150 06
- Research Site
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Slany, Tsjekkia, 274 01
- Research Site
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Svitavy, Tsjekkia, 568 25
- Research Site
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Bad Krozingen, Tyskland, 79189
- Research Site
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Berlin, Tyskland, 10787
- Research Site
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Berlin, Tyskland, 13353
- Research Site
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Berlin (Hellersdorf), Tyskland, 12627
- Research Site
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Dresden, Tyskland, 01307
- Research Site
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Heppenheim, Tyskland, 64646
- Research Site
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Homburg, Tyskland, 66421
- Research Site
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Köln, Tyskland, 50937
- Research Site
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Leipzig, Tyskland, 04103
- Research Site
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Magdeburg, Tyskland, 39112
- Research Site
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Messkirch, Tyskland, 88605
- Research Site
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München, Tyskland, 80638
- Research Site
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Witten, Tyskland, 58455
- Research Site
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Baja, Ungarn, 6500
- Research Site
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Berettyoujfalu, Ungarn, 4100
- Research Site
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Budapest, Ungarn, 1085
- Research Site
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Eger, Ungarn, 3300
- Research Site
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Gyongyos, Ungarn, 3200
- Research Site
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Hodmezovasarhely, Ungarn, 6800
- Research Site
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Jaszbereny, Ungarn, 5100
- Research Site
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Komarom, Ungarn, 2921
- Research Site
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Mosonmagyarovar, Ungarn, 9200
- Research Site
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Pecs, Ungarn, 7624
- Research Site
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Szeged, Ungarn, 6720
- Research Site
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Salzburg, Østerrike, 5020
- Research Site
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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 til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).
Exclusion Criteria:
- Experienced a treatment-related serious adverse event that led to study drug discontinuation in the parent study
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard of Care
Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).
At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
|
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Andre navn:
Standard of care therapy as per local practices.
This could include prescribed therapies and/or dietary/exercise regimes
|
|
Eksperimentell: Evolocumab + Standard of Care
Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period.
Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
|
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Andre navn:
Standard of care therapy as per local practices.
This could include prescribed therapies and/or dietary/exercise regimes
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Adverse Events
Tidsramme: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
|
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
|
48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change From Baseline in LDL-C at Weeks 48 and 104
Tidsramme: Baseline of the parent study and weeks 48 amd 104
|
Baseline of the parent study and weeks 48 amd 104
|
|
Change From Baseline in LDL-C at Weeks 48 and 104
Tidsramme: Baseline of the parent study and weeks 48 amd 104
|
Baseline of the parent study and weeks 48 amd 104
|
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
- Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
- Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
- Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.
- Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.
- Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.
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)
23. april 2013
Primær fullføring (Faktiske)
31. mai 2018
Studiet fullført (Faktiske)
31. mai 2018
Datoer for studieregistrering
Først innsendt
1. mai 2013
Først innsendt som oppfylte QC-kriteriene
15. mai 2013
Først lagt ut (Anslag)
16. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juni 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mai 2019
Sist bekreftet
1. mai 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20120138
- 2012-004357-83 (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. .