Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia (OSLER-2)

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia and Mixed Dyslipidemia
• Intervention / Treatment: Biological: Evolocumab; Drug: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 3681
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2015
      • Research Site
    • Maroubra, New South Wales, Australia, 2035
      • Research Site
    • Sydney, New South Wales, Australia, 2022
      • Research Site
    • Sydney, New South Wales, Australia, 2010
      • Research Site
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Research Site
    • Carina Heights, Queensland, Australia, 4152
      • Research Site
    • Sherwood, Queensland, Australia, 4075
      • Research Site
    • Woolloongabba, Queensland, Australia, 4102
      • Research Site
  • South Australia
    • Ashford, South Australia, Australia, 5035
      • Research Site
    • Fullarton, South Australia, Australia, 5063
      • Research Site
  • Victoria
    • Heidelberg Heights, Victoria, Australia, 3081
      • Research Site
    • Melbourne, Victoria, Australia, 3004
      • Research Site
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Research Site
• Austria
  • Salzburg, Austria, 5020
    • Research Site
• Belgium
  • Anthée, Belgium, 5520
    • Research Site
  • Blankenberge, Belgium, 8370
    • Research Site
  • Bruxelles, Belgium, 1200
    • Research Site
  • Bruxelles, Belgium, 1080
    • Research Site
  • Chênée, Belgium, 4032
    • Research Site
  • Gent, Belgium, 9000
    • Research Site
  • Gozee, Belgium, 6534
    • Research Site
  • Gribomont, Belgium, 6887
    • Research Site
  • Halen, Belgium, 3545
    • Research Site
  • Ham, Belgium, 3945
    • Research Site
  • Hasselt, Belgium, 3500
    • Research Site
  • La Louvière, Belgium, 7100
    • Research Site
  • Linkebeek, Belgium, 1630
    • Research Site
  • Oostende, Belgium, 8400
    • Research Site
  • Tessenderlo, Belgium, 3980
    • Research Site
  • Tremelo, Belgium, 3120
    • Research Site
  • Vilvoorde, Belgium, 1800
    • Research Site
• Canada
  • Quebec, Canada, G1V 4M6
    • Research Site
  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 1T4
      • Research Site
    • Kelowna, British Columbia, Canada, V1Y 1V6
      • Research Site
    • Surrey, British Columbia, Canada, V3V 1N1
      • Research Site
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Research Site
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • Research Site
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
      • Research Site
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • Research Site
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
      • Research Site
    • Hamilton, Ontario, Canada, L8L 2X2
      • Research Site
    • London, Ontario, Canada, N5W 6A2
      • Research Site
    • London, Ontario, Canada, N6A 5K8
      • Research Site
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Research Site
    • Oshawa, Ontario, Canada, L1J 2K1
      • Research Site
    • Peterborough, Ontario, Canada, K9J 0B2
      • Research Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Research Site
    • Toronto, Ontario, Canada, M9V 4B4
      • Research Site
    • Toronto, Ontario, Canada, M9W 4L6
      • Research Site
    • Toronto, Ontario, Canada, M8V 3X8
      • Research Site
    • Woodstock, Ontario, Canada, N4S 5P5
      • Research Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Research Site
    • Granby, Quebec, Canada, J2G 8Z9
      • Research Site
    • Greenfield Park, Quebec, Canada, J4V 2G8
      • Research Site
    • Lachine, Quebec, Canada, H8S 2E4
      • Research Site
    • Montreal, Quebec, Canada, H3A 1A1
      • Research Site
    • Montreal, Quebec, Canada, H4N 2W2
      • Research Site
    • Montreal, Quebec, Canada, H2W 1R7
      • Research Site
    • Pointe-Claire, Quebec, Canada, H9R 3J1
      • Research Site
• Czechia
  • Brno, Czechia, 602 00
    • Research Site
  • Brno, Czechia, 603 00
    • Research Site
  • Chomutov, Czechia, 430 02
    • Research Site
  • Hradec Kralove, Czechia, 500 05
    • Research Site
  • Kladno, Czechia, 272 01
    • Research Site
  • Litomerice, Czechia, 412 01
    • Research Site
  • Moravske Budejovice, Czechia, 676 02
    • Research Site
  • Olomouc, Czechia, 775 20
    • Research Site
  • Pardubice, Czechia, 530 02
    • Research Site
  • Plzen, Czechia, 305 99
    • Research Site
  • Praha 2, Czechia, 128 08
    • Research Site
  • Praha 3, Czechia, 130 00
    • Research Site
  • Praha 4, Czechia, 140 21
    • Research Site
  • Praha 5, Czechia, 150 06
    • Research Site
  • Slany, Czechia, 274 01
    • Research Site
  • Svitavy, Czechia, 568 25
    • Research Site
• Denmark
  • Aalborg, Denmark, 9000
    • Research Site
  • Aarhus N, Denmark, 8200
    • Research Site
  • Ballerup, Denmark, 2750
    • Research Site
  • Glostrup, Denmark, 2600
    • Research Site
  • Vejle, Denmark, 7100
    • Research Site
• France
  • Brest Cedex 2, France, 29200
    • Research Site
  • Bron, France, 69677
    • Research Site
  • Caen Cedex 9, France, 14033
    • Research Site
  • Dijon, France, 21034
    • Research Site
  • Montpellier cedex 05, France, 34295
    • Research Site
  • Nantes Cedex 1, France, 44093
    • Research Site
  • Paris Cedex 12, France, 75571
    • Research Site
  • Paris Cedex 13, France, 75651
    • Research Site
  • Vénissieux, France, 69200
    • Research Site
• Germany
  • Bad Krozingen, Germany, 79189
    • Research Site
  • Berlin, Germany, 10787
    • Research Site
  • Berlin, Germany, 13353
    • Research Site
  • Berlin (Hellersdorf), Germany, 12627
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Heppenheim, Germany, 64646
    • Research Site
  • Homburg, Germany, 66421
    • Research Site
  • Köln, Germany, 50937
    • Research Site
  • Leipzig, Germany, 04103
    • Research Site
  • Magdeburg, Germany, 39112
    • Research Site
  • Messkirch, Germany, 88605
    • Research Site
  • München, Germany, 80638
    • Research Site
  • Witten, Germany, 58455
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
  • New Territories, Hong Kong
    • Research Site
• Hungary
  • Baja, Hungary, 6500
    • Research Site
  • Berettyoujfalu, Hungary, 4100
    • Research Site
  • Budapest, Hungary, 1085
    • Research Site
  • Eger, Hungary, 3300
    • Research Site
  • Gyongyos, Hungary, 3200
    • Research Site
  • Hodmezovasarhely, Hungary, 6800
    • Research Site
  • Jaszbereny, Hungary, 5100
    • Research Site
  • Komarom, Hungary, 2921
    • Research Site
  • Mosonmagyarovar, Hungary, 9200
    • Research Site
  • Pecs, Hungary, 7624
    • Research Site
  • Szeged, Hungary, 6720
    • Research Site
• Italy
  • Bologna, Italy, 40138
    • Research Site
  • Cagliari, Italy, 09134
    • Research Site
  • Chieti, Italy, 66100
    • Research Site
  • Cinisello Balsamo (MI), Italy, 20092
    • Research Site
  • Ferrara, Italy, 44124
    • Research Site
  • Milano, Italy, 20162
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Perugia, Italy, 06129
    • Research Site
  • Pisa, Italy, 56124
    • Research Site
  • Pisa, Italy, 56100
    • Research Site
  • Trieste, Italy, 34149
    • Research Site
• Japan
  • Chiba
    • Noda-shi, Chiba, Japan, 278-0004
      • Research Site
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 810-0014
      • Research Site
    • Fukuoka-shi, Fukuoka, Japan, 810-0066
      • Research Site
    • Fukuoka-shi, Fukuoka, Japan, 819-8551
      • Research Site
    • Kitakyusyu-shi, Fukuoka, Japan, 807-0856
      • Research Site
  • Fukushima
    • Koriyama-shi, Fukushima, Japan, 963-0209
      • Research Site
    • Koriyama-shi, Fukushima, Japan, 963-8026
      • Research Site
    • Koriyama-shi, Fukushima, Japan, 963-8041
      • Research Site
    • Koriyama-shi, Fukushima, Japan, 963-8832
      • Research Site
    • Koriyama-shi, Fukushima, Japan, 963-8862
      • Research Site
  • Gunma
    • Maebashi-shi, Gunma, Japan, 371-0022
      • Research Site
    • Takasaki-shi, Gunma, Japan, 370-3524
      • Research Site
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-0063
      • Research Site
    • Sapporo-shi, Hokkaido, Japan, 003-0026
      • Research Site
    • Sapporo-shi, Hokkaido, Japan, 003-0825
      • Research Site
  • Ibaraki
    • Tsuchiura-shi, Ibaraki, Japan, 300-0047
      • Research Site
  • Iwate
    • Morioka-shi, Iwate, Japan, 020-0066
      • Research Site
  • Kagawa
    • Takamatsu-shi, Kagawa, Japan, 760-0018
      • Research Site
    • Takamatsu-shi, Kagawa, Japan, 760-0076
      • Research Site
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 231-0023
      • Research Site
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 615-8125
      • Research Site
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 983-0039
      • Research Site
    • Sendai-shi, Miyagi, Japan, 983-0835
      • Research Site
    • Sendai-shi, Miyagi, Japan, 989-3122
      • Research Site
  • Okinawa
    • Tomigusuku-shi, Okinawa, Japan, 901-0243
      • Research Site
  • Osaka
    • Ibaraki-shi, Osaka, Japan, 567-0876
      • Research Site
    • Toyonaka-shi, Osaka, Japan, 560-0082
      • Research Site
  • Saitama
    • Koshigaya-shi, Saitama, Japan, 343-0828
      • Research Site
    • Niiza-shi, Saitama, Japan, 352-0014
      • Research Site
  • Tokyo
    • Arakawa-ku, Tokyo, Japan, 116-0002
      • Research Site
    • Chiyoda-ku, Tokyo, Japan, 101-0041
      • Research Site
    • Chofu-shi, Tokyo, Japan, 182-0006
      • Research Site
    • Edogawa-ku, Tokyo, Japan, 133-0061
      • Research Site
    • Hachioji-shi, Tokyo, Japan, 192-0046
      • Research Site
    • Katsushika-ku, Tokyo, Japan, 124-0024
      • Research Site
    • Koto-ku, Tokyo, Japan, 135-0011
      • Research Site
    • Minato-ku, Tokyo, Japan, 108-0075
      • Research Site
    • Minato-ku, Tokyo, Japan, 105-7390
      • Research Site
    • Ota-ku, Tokyo, Japan, 144-0034
      • Research Site
    • Setagaya-ku, Tokyo, Japan, 155-0031
      • Research Site
    • Shibuya-ku, Tokyo, Japan, 150-0012
      • Research Site
    • Shinagawa-ku, Tokyo, Japan, 140-0011
      • Research Site
    • Shinagawa-ku, Tokyo, Japan, 141-0001
      • Research Site
    • Shinagawa-ku, Tokyo, Japan, 141-6003
      • Research Site
    • Shinagawa-ku, Tokyo, Japan, 142-0053
      • Research Site
    • Toshima-ku, Tokyo, Japan, 171-0021
      • Research Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Research Site
  • Seoul, Korea, Republic of, 120-752
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Research Site
  • Den Helder, Netherlands, 1782 GZ
    • Research Site
  • Groningen, Netherlands, 9713 GZ
    • Research Site
  • Groningen, Netherlands, 9728 NT
    • Research Site
  • Hoogeveen, Netherlands, 7909 AA
    • Research Site
  • Hoorn, Netherlands, 1625 HV
    • Research Site
  • Nijmegen, Netherlands, 6525 EZ
    • Research Site
  • Rotterdam, Netherlands, 3045 PM
    • Research Site
  • Tilburg, Netherlands, 5022 GC
    • Research Site
  • Utrecht, Netherlands, 3584 CX
    • Research Site
  • Waalwijk, Netherlands, 5141 BM
    • Research Site
  • Zwijndrecht, Netherlands, 3331 LZ
    • Research Site
• New Zealand
  • Christchurch, New Zealand, 8011
    • Research Site
• Norway
  • Oslo, Norway, 0373
    • Research Site
  • Ålesund, Norway, 6003
    • Research Site
• Poland
  • Lodz, Poland, 91-078
    • Research Site
• Russian Federation
  • Barnaul, Russian Federation, 656055
    • Research Site
  • Kemerovo, Russian Federation, 650002
    • Research Site
  • Moscow, Russian Federation, 121552
    • Research Site
  • Novosibirsk, Russian Federation, 630047
    • Research Site
  • Saint Petersburg, Russian Federation, 197022
    • Research Site
  • Saratov, Russian Federation, 410054
    • Research Site
• South Africa
  • Bloemfontein, South Africa, 9301
    • Research Site
  • Gauteng
    • Centurion, Gauteng, South Africa, 0157
      • Research Site
    • Johannesburg, Gauteng, South Africa, 2193
      • Research Site
    • Midrand, Gauteng, South Africa, 1685
      • Research Site
    • Sunninghill, Gauteng, South Africa, 2157
      • Research Site
  • KwaZulu-Natal
    • Amanzimtoti, KwaZulu-Natal, South Africa, 4126
      • Research Site
  • Western Cape
    • Observatory, Western Cape, South Africa, 7925
      • Research Site
    • Paarl, Western Cape, South Africa, 7646
      • Research Site
    • Parow, Western Cape, South Africa, 7505
      • Research Site
    • Somerset West, Western Cape, South Africa, 7130
      • Research Site
• Spain
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Madrid, Spain, 28029
    • Research Site
  • Andalucía
    • Cordoba, Andalucía, Spain, 14004
      • Research Site
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Research Site
  • Cataluña
    • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Research Site
    • Reus, Cataluña, Spain, 43204
      • Research Site
• Sweden
  • Göteborg, Sweden, 413 45
    • Research Site
  • Lund, Sweden, 222 21
    • Research Site
  • Stockholm, Sweden, 141 86
    • Research Site
  • Stockholm, Sweden, 171 45
    • Research Site
  • Stockholm, Sweden, 111 57
    • Research Site
  • Uddevalla, Sweden, 451 50
    • Research Site
  • Örebro, Sweden, 701 46
    • Research Site
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Research Site
  • Geneva 14, Switzerland, 1211
    • Research Site
  • Lausanne, Switzerland, 1011
    • Research Site
  • Lugano, Switzerland, 6900
    • Research Site
  • Muensterlingen, Switzerland, 8596
    • Research Site
  • Reinach, Switzerland, 4153
    • Research Site
  • St. Gallen, Switzerland, 9007
    • Research Site
  • Zurich, Switzerland, 8063
    • Research Site
  • Zurich, Switzerland, 8091
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Research Site
  • Birmingham, United Kingdom, B15 2SQ
    • Research Site
  • Blackpool, United Kingdom, FY3 7EN
    • Research Site
  • Cardiff, United Kingdom, CF14 5GJ
    • Research Site
  • Chesterfield, United Kingdom, S40 4AA
    • Research Site
  • Chorley, United Kingdom, PR7 7NA
    • Research Site
  • Coventry, United Kingdom, CV2 2DX
    • Research Site
  • Doncaster, United Kingdom, DN9 1EP
    • Research Site
  • Glasgow, United Kingdom, G20 0SP
    • Research Site
  • Glasgow, United Kingdom, G12 8TA
    • Research Site
  • Glasgow, United Kingdom, G45 9AW
    • Research Site
  • Liverpool, United Kingdom, L7 8XP
    • Research Site
  • Liverpool, United Kingdom, L22 0LG
    • Research Site
  • London, United Kingdom, W6 8RF
    • Research Site
  • London, United Kingdom, SE1 7EH
    • Research Site
  • London, United Kingdom, NW3 2QG
    • Research Site
  • Manchester, United Kingdom, M15 6SX
    • Research Site
  • Manchester, United Kingdom, M13 9WL
    • Research Site
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Research Site
  • Reading, United Kingdom, RG2 0TG
    • Research Site
  • Telford, United Kingdom, TF1 6TF
    • Research Site
  • Wakefield, United Kingdom, WF1 4DG
    • Research Site
  • West Bromwich, United Kingdom, B71 4HJ
    • Research Site
  • Whitby, United Kingdom, YO21 1SD
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Research Site
    • Birmingham, Alabama, United States, 35216
      • Research Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
    • Phoenix, Arizona, United States, 85020
      • Research Site
    • Tucson, Arizona, United States, 85712
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Site
  • California
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Carmichael, California, United States, 95608
      • Research Site
    • Encinitas, California, United States, 92024
      • Research Site
    • Huntington Beach, California, United States, 92648
      • Research Site
    • Los Angeles, California, United States, 90048
      • Research Site
    • Mission Viejo, California, United States, 92691
      • Research Site
    • Newport Beach, California, United States, 92663
      • Research Site
    • San Diego, California, United States, 92111
      • Research Site
    • Santa Ana, California, United States, 92705
      • Research Site
    • Santa Rosa, California, United States, 95405
      • Research Site
    • Spring Valley, California, United States, 91978
      • Research Site
    • Thousand Oaks, California, United States, 91360
      • Research Site
    • Torrance, California, United States, 90509
      • Research Site
    • Tustin, California, United States, 92780
      • Research Site
    • Ventura, California, United States, 93003
      • Research Site
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Research Site
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Research Site
    • DeLand, Florida, United States, 32720
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Melbourne, Florida, United States, 32901
      • Research Site
    • Miami, Florida, United States, 33173
      • Research Site
    • Miami, Florida, United States, 33144
      • Research Site
    • Ponte Vedra, Florida, United States, 32081
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
    • Sanford, Florida, United States, 32771
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Research Site
    • Atlanta, Georgia, United States, 30338
      • Research Site
    • Atlanta, Georgia, United States, 30342
      • Research Site
    • Gainesville, Georgia, United States, 30501
      • Research Site
    • Savannah, Georgia, United States, 31406
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Research Site
    • Sterling, Illinois, United States, 61081
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Research Site
    • Munster, Indiana, United States, 46321
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Research Site
    • Louisville, Kentucky, United States, 40213
      • Research Site
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Research Site
  • Maine
    • Auburn, Maine, United States, 04210
      • Research Site
    • Bangor, Maine, United States, 04401
      • Research Site
    • Portland, Maine, United States, 04101
      • Research Site
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Research Site
    • Columbia, Maryland, United States, 21045
      • Research Site
    • Towson, Maryland, United States, 21204
      • Research Site
  • Massachusetts
    • Ayer, Massachusetts, United States, 01432
      • Research Site
    • Quincy, Massachusetts, United States, 02169
      • Research Site
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Research Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Research Site
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Research Site
    • Tupelo, Mississippi, United States, 38801
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
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  • Nevada
    • Henderson, Nevada, United States, 89052
      • Research Site
    • Las Vegas, Nevada, United States, 89148
      • Research Site
  • New York
    • Endwell, New York, United States, 13760
      • Research Site
    • Manlius, New York, United States, 13104
      • Research Site
    • New Windsor, New York, United States, 12553
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • Rochester, New York, United States, 14609
      • Research Site
    • Williamsville, New York, United States, 14221
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Research Site
    • Raleigh, North Carolina, United States, 27612
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Research Site
  • Ohio
    • Akron, Ohio, United States, 44311
      • Research Site
    • Cadiz, Ohio, United States, 43907
      • Research Site
    • Canton, Ohio, United States, 44710
      • Research Site
    • Cincinnati, Ohio, United States, 45236
      • Research Site
    • Cincinnati, Ohio, United States, 45219
      • Research Site
    • Cincinnati, Ohio, United States, 45227
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Research Site
    • Dayton, Ohio, United States, 45414
      • Research Site
    • Mansfield, Ohio, United States, 44906
      • Research Site
    • Marion, Ohio, United States, 43302
      • Research Site
    • Sandusky, Ohio, United States, 44870
      • Research Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73103
      • Research Site
  • Oregon
    • Hillsboro, Oregon, United States, 97123
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Research Site
    • Lansdale, Pennsylvania, United States, 19446
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15216
      • Research Site
    • York, Pennsylvania, United States, 17405
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Site
    • Charleston, South Carolina, United States, 29425
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Research Site
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Research Site
  • Texas
    • Austin, Texas, United States, 78731
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • Dallas, Texas, United States, 75230
      • Research Site
    • Houston, Texas, United States, 77030
      • Research Site
    • Houston, Texas, United States, 77074
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Research Site
    • Richmond, Virginia, United States, 23294
      • Research Site
    • Suffolk, Virginia, United States, 23435
      • Research Site
  • Washington
    • Renton, Washington, United States, 98057
      • Research Site
    • Seattle, Washington, United States, 98104
      • Research Site
    • Tacoma, Washington, United States, 98405
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Biological: Evolocumab; Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen; Other Names: Repatha; AMG 145; Drug: Standard of Care; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Experimental: 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.	Biological: Evolocumab; Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen; Other Names: Repatha; AMG 145; Drug: Standard of Care; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in LDL-C at Weeks 48 and 104	Baseline of the parent study and weeks 48 amd 104
Change From Baseline in LDL-C at Weeks 48 and 104	Baseline of the parent study and weeks 48 amd 104

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2013
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: May 1, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Cholesterol; Elevated Cholesterol; High cholesterol; Raised cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Evolocumab
• Other Study ID Numbers: 20120138; 2012-004357-83 (EudraCT Number)