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

20. maj 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Hyperlipidemia and Mixed Dyslipidemia

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3681

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Australien
- New South Wales
  - Camperdown, New South Wales, Australien, 2015
    - Research Site
  - Maroubra, New South Wales, Australien, 2035
    - Research Site
  - Sydney, New South Wales, Australien, 2022
    - Research Site
  - Sydney, New South Wales, Australien, 2010
    - Research Site
- Queensland
  - Auchenflower, Queensland, Australien, 4066
    - Research Site
  - Carina Heights, Queensland, Australien, 4152
    - Research Site
  - Sherwood, Queensland, Australien, 4075
    - Research Site
  - Woolloongabba, Queensland, Australien, 4102
    - Research Site
- South Australia
  - Ashford, South Australia, Australien, 5035
    - Research Site
  - Fullarton, South Australia, Australien, 5063
    - Research Site
- Victoria
  - Heidelberg Heights, Victoria, Australien, 3081
    - Research Site
  - Melbourne, Victoria, Australien, 3004
    - Research Site
- Western Australia
  - Perth, Western Australia, Australien, 6000
    - Research Site
Belgien
- - Anthée, Belgien, 5520
    - Research Site
  - Blankenberge, Belgien, 8370
    - Research Site
  - Bruxelles, Belgien, 1200
    - Research Site
  - Bruxelles, Belgien, 1080
    - Research Site
  - Chênée, Belgien, 4032
    - Research Site
  - Gent, Belgien, 9000
    - Research Site
  - Gozee, Belgien, 6534
    - Research Site
  - Gribomont, Belgien, 6887
    - Research Site
  - Halen, Belgien, 3545
    - Research Site
  - Ham, Belgien, 3945
    - Research Site
  - Hasselt, Belgien, 3500
    - Research Site
  - La Louvière, Belgien, 7100
    - Research Site
  - Linkebeek, Belgien, 1630
    - Research Site
  - Oostende, Belgien, 8400
    - Research Site
  - Tessenderlo, Belgien, 3980
    - Research Site
  - Tremelo, Belgien, 3120
    - Research Site
  - Vilvoorde, Belgien, 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
Danmark
- - Aalborg, Danmark, 9000
    - Research Site
  - Aarhus N, Danmark, 8200
    - Research Site
  - Ballerup, Danmark, 2750
    - Research Site
  - Glostrup, Danmark, 2600
    - Research Site
  - Vejle, Danmark, 7100
    - Research Site
Den Russiske Føderation
- - Barnaul, Den Russiske Føderation, 656055
    - Research Site
  - Kemerovo, Den Russiske Føderation, 650002
    - Research Site
  - Moscow, Den Russiske Føderation, 121552
    - Research Site
  - Novosibirsk, Den Russiske Føderation, 630047
    - Research Site
  - Saint Petersburg, Den Russiske Føderation, 197022
    - Research Site
  - Saratov, Den Russiske Føderation, 410054
    - Research Site
Det Forenede Kongerige
- - Birmingham, Det Forenede Kongerige, B15 2TH
    - Research Site
  - Birmingham, Det Forenede Kongerige, B15 2SQ
    - Research Site
  - Blackpool, Det Forenede Kongerige, FY3 7EN
    - Research Site
  - Cardiff, Det Forenede Kongerige, CF14 5GJ
    - Research Site
  - Chesterfield, Det Forenede Kongerige, S40 4AA
    - Research Site
  - Chorley, Det Forenede Kongerige, PR7 7NA
    - Research Site
  - Coventry, Det Forenede Kongerige, CV2 2DX
    - Research Site
  - Doncaster, Det Forenede Kongerige, DN9 1EP
    - Research Site
  - Glasgow, Det Forenede Kongerige, G20 0SP
    - Research Site
  - Glasgow, Det Forenede Kongerige, G12 8TA
    - Research Site
  - Glasgow, Det Forenede Kongerige, G45 9AW
    - Research Site
  - Liverpool, Det Forenede Kongerige, L7 8XP
    - Research Site
  - Liverpool, Det Forenede Kongerige, L22 0LG
    - Research Site
  - London, Det Forenede Kongerige, W6 8RF
    - Research Site
  - London, Det Forenede Kongerige, SE1 7EH
    - Research Site
  - London, Det Forenede Kongerige, NW3 2QG
    - Research Site
  - Manchester, Det Forenede Kongerige, M15 6SX
    - Research Site
  - Manchester, Det Forenede Kongerige, M13 9WL
    - Research Site
  - Newcastle upon Tyne, Det Forenede Kongerige, NE1 4LP
    - Research Site
  - Reading, Det Forenede Kongerige, RG2 0TG
    - Research Site
  - Telford, Det Forenede Kongerige, TF1 6TF
    - Research Site
  - Wakefield, Det Forenede Kongerige, WF1 4DG
    - Research Site
  - West Bromwich, Det Forenede Kongerige, B71 4HJ
    - Research Site
  - Whitby, Det Forenede Kongerige, YO21 1SD
    - Research Site
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294
    - Research Site
  - Birmingham, Alabama, Forenede Stater, 35216
    - Research Site
- Arizona
  - Chandler, Arizona, Forenede Stater, 85224
    - Research Site
  - Phoenix, Arizona, Forenede Stater, 85020
    - Research Site
  - Tucson, Arizona, Forenede Stater, 85712
    - Research Site
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Research Site
- California
  - Beverly Hills, California, Forenede Stater, 90211
    - Research Site
  - Carmichael, California, Forenede Stater, 95608
    - Research Site
  - Encinitas, California, Forenede Stater, 92024
    - Research Site
  - Huntington Beach, California, Forenede Stater, 92648
    - Research Site
  - Los Angeles, California, Forenede Stater, 90048
    - Research Site
  - Mission Viejo, California, Forenede Stater, 92691
    - Research Site
  - Newport Beach, California, Forenede Stater, 92663
    - Research Site
  - San Diego, California, Forenede Stater, 92111
    - Research Site
  - Santa Ana, California, Forenede Stater, 92705
    - Research Site
  - Santa Rosa, California, Forenede Stater, 95405
    - Research Site
  - Spring Valley, California, Forenede Stater, 91978
    - Research Site
  - Thousand Oaks, California, Forenede Stater, 91360
    - Research Site
  - Torrance, California, Forenede Stater, 90509
    - Research Site
  - Tustin, California, Forenede Stater, 92780
    - Research Site
  - Ventura, California, Forenede Stater, 93003
    - Research Site
- Colorado
  - Littleton, Colorado, Forenede Stater, 80120
    - Research Site
- Florida
  - Daytona Beach, Florida, Forenede Stater, 32117
    - Research Site
  - DeLand, Florida, Forenede Stater, 32720
    - Research Site
  - Jacksonville, Florida, Forenede Stater, 32216
    - Research Site
  - Melbourne, Florida, Forenede Stater, 32901
    - Research Site
  - Miami, Florida, Forenede Stater, 33173
    - Research Site
  - Miami, Florida, Forenede Stater, 33144
    - Research Site
  - Ponte Vedra, Florida, Forenede Stater, 32081
    - Research Site
  - Port Charlotte, Florida, Forenede Stater, 33952
    - Research Site
  - Sanford, Florida, Forenede Stater, 32771
    - Research Site
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30328
    - Research Site
  - Atlanta, Georgia, Forenede Stater, 30338
    - Research Site
  - Atlanta, Georgia, Forenede Stater, 30342
    - Research Site
  - Gainesville, Georgia, Forenede Stater, 30501
    - Research Site
  - Savannah, Georgia, Forenede Stater, 31406
    - Research Site
- Illinois
  - Chicago, Illinois, Forenede Stater, 60654
    - Research Site
  - Sterling, Illinois, Forenede Stater, 61081
    - Research Site
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46260
    - Research Site
  - Munster, Indiana, Forenede Stater, 46321
    - Research Site
- Iowa
  - Iowa City, Iowa, Forenede Stater, 52242
    - Research Site
- Kansas
  - Kansas City, Kansas, Forenede Stater, 66160
    - Research Site
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40504
    - Research Site
  - Louisville, Kentucky, Forenede Stater, 40213
    - Research Site
- Louisiana
  - Monroe, Louisiana, Forenede Stater, 71201
    - Research Site
- Maine
  - Auburn, Maine, Forenede Stater, 04210
    - Research Site
  - Bangor, Maine, Forenede Stater, 04401
    - Research Site
  - Portland, Maine, Forenede Stater, 04101
    - Research Site
- Maryland
  - Bethesda, Maryland, Forenede Stater, 20817
    - Research Site
  - Columbia, Maryland, Forenede Stater, 21045
    - Research Site
  - Towson, Maryland, Forenede Stater, 21204
    - Research Site
- Massachusetts
  - Ayer, Massachusetts, Forenede Stater, 01432
    - Research Site
  - Quincy, Massachusetts, Forenede Stater, 02169
    - Research Site
- Michigan
  - Ypsilanti, Michigan, Forenede Stater, 48197
    - Research Site
- Minnesota
  - Edina, Minnesota, Forenede Stater, 55435
    - Research Site
- Mississippi
  - Olive Branch, Mississippi, Forenede Stater, 38654
    - Research Site
  - Tupelo, Mississippi, Forenede Stater, 38801
    - Research Site
- Missouri
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Research Site
- Nevada
  - Henderson, Nevada, Forenede Stater, 89052
    - Research Site
  - Las Vegas, Nevada, Forenede Stater, 89148
    - Research Site
- New York
  - Endwell, New York, Forenede Stater, 13760
    - Research Site
  - Manlius, New York, Forenede Stater, 13104
    - Research Site
  - New Windsor, New York, Forenede Stater, 12553
    - Research Site
  - New York, New York, Forenede Stater, 10029
    - Research Site
  - Rochester, New York, Forenede Stater, 14609
    - Research Site
  - Williamsville, New York, Forenede Stater, 14221
    - Research Site
- North Carolina
  - Raleigh, North Carolina, Forenede Stater, 27609
    - Research Site
  - Raleigh, North Carolina, Forenede Stater, 27612
    - Research Site
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - Research Site
- North Dakota
  - Fargo, North Dakota, Forenede Stater, 58103
    - Research Site
- Ohio
  - Akron, Ohio, Forenede Stater, 44311
    - Research Site
  - Cadiz, Ohio, Forenede Stater, 43907
    - Research Site
  - Canton, Ohio, Forenede Stater, 44710
    - Research Site
  - Cincinnati, Ohio, Forenede Stater, 45236
    - Research Site
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Research Site
  - Cincinnati, Ohio, Forenede Stater, 45227
    - Research Site
  - Cleveland, Ohio, Forenede Stater, 44195
    - Research Site
  - Dayton, Ohio, Forenede Stater, 45414
    - Research Site
  - Mansfield, Ohio, Forenede Stater, 44906
    - Research Site
  - Marion, Ohio, Forenede Stater, 43302
    - Research Site
  - Sandusky, Ohio, Forenede Stater, 44870
    - Research Site
- Oklahoma
  - Norman, Oklahoma, Forenede Stater, 73069
    - Research Site
  - Oklahoma City, Oklahoma, Forenede Stater, 73103
    - Research Site
- Oregon
  - Hillsboro, Oregon, Forenede Stater, 97123
    - Research Site
- Pennsylvania
  - Duncansville, Pennsylvania, Forenede Stater, 16635
    - Research Site
  - Lansdale, Pennsylvania, Forenede Stater, 19446
    - Research Site
  - Pittsburgh, Pennsylvania, Forenede Stater, 15216
    - Research Site
  - York, Pennsylvania, Forenede Stater, 17405
    - Research Site
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - Research Site
  - Charleston, South Carolina, Forenede Stater, 29425
    - Research Site
  - Mount Pleasant, South Carolina, Forenede Stater, 29464
    - Research Site
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57702
    - Research Site
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Research Site
- Tennessee
  - Jackson, Tennessee, Forenede Stater, 38305
    - Research Site
  - Nashville, Tennessee, Forenede Stater, 37203
    - Research Site
- Texas
  - Austin, Texas, Forenede Stater, 78731
    - Research Site
  - Dallas, Texas, Forenede Stater, 75231
    - Research Site
  - Dallas, Texas, Forenede Stater, 75230
    - Research Site
  - Houston, Texas, Forenede Stater, 77030
    - Research Site
  - Houston, Texas, Forenede Stater, 77074
    - Research Site
  - San Antonio, Texas, Forenede Stater, 78229
    - Research Site
- Virginia
  - Norfolk, Virginia, Forenede Stater, 23502
    - Research Site
  - Richmond, Virginia, Forenede Stater, 23294
    - Research Site
  - Suffolk, Virginia, Forenede Stater, 23435
    - Research Site
- Washington
  - Renton, Washington, Forenede Stater, 98057
    - Research Site
  - Seattle, Washington, Forenede Stater, 98104
    - Research Site
  - Tacoma, Washington, Forenede Stater, 98405
    - Research Site
Frankrig
- - Brest Cedex 2, Frankrig, 29200
    - Research Site
  - Bron, Frankrig, 69677
    - Research Site
  - Caen Cedex 9, Frankrig, 14033
    - Research Site
  - Dijon, Frankrig, 21034
    - Research Site
  - Montpellier cedex 05, Frankrig, 34295
    - Research Site
  - Nantes Cedex 1, Frankrig, 44093
    - Research Site
  - Paris Cedex 12, Frankrig, 75571
    - Research Site
  - Paris Cedex 13, Frankrig, 75651
    - Research Site
  - Vénissieux, Frankrig, 69200
    - Research Site
Holland
- - Amsterdam, Holland, 1105 AZ
    - Research Site
  - Den Helder, Holland, 1782 GZ
    - Research Site
  - Groningen, Holland, 9713 GZ
    - Research Site
  - Groningen, Holland, 9728 NT
    - Research Site
  - Hoogeveen, Holland, 7909 AA
    - Research Site
  - Hoorn, Holland, 1625 HV
    - Research Site
  - Nijmegen, Holland, 6525 EZ
    - Research Site
  - Rotterdam, Holland, 3045 PM
    - Research Site
  - Tilburg, Holland, 5022 GC
    - Research Site
  - Utrecht, Holland, 3584 CX
    - Research Site
  - Waalwijk, Holland, 5141 BM
    - Research Site
  - Zwijndrecht, Holland, 3331 LZ
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong
    - Research Site
  - New Territories, Hong Kong
    - Research Site
Italien
- - Bologna, Italien, 40138
    - Research Site
  - Cagliari, Italien, 09134
    - Research Site
  - Chieti, Italien, 66100
    - Research Site
  - Cinisello Balsamo (MI), Italien, 20092
    - Research Site
  - Ferrara, Italien, 44124
    - Research Site
  - Milano, Italien, 20162
    - Research Site
  - Napoli, Italien, 80131
    - Research Site
  - Padova, Italien, 35128
    - Research Site
  - Perugia, Italien, 06129
    - Research Site
  - Pisa, Italien, 56124
    - Research Site
  - Pisa, Italien, 56100
    - Research Site
  - Trieste, Italien, 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, Republikken
- - Seoul, Korea, Republikken, 135-710
    - Research Site
  - Seoul, Korea, Republikken, 120-752
    - Research Site
New Zealand
- - Christchurch, New Zealand, 8011
    - Research Site
Norge
- - Oslo, Norge, 0373
    - Research Site
  - Ålesund, Norge, 6003
    - Research Site
Polen
- - Lodz, Polen, 91-078
    - Research Site
Schweiz
- - Bellinzona, Schweiz, 6500
    - Research Site
  - Geneva 14, Schweiz, 1211
    - Research Site
  - Lausanne, Schweiz, 1011
    - Research Site
  - Lugano, Schweiz, 6900
    - Research Site
  - Muensterlingen, Schweiz, 8596
    - Research Site
  - Reinach, Schweiz, 4153
    - Research Site
  - St. Gallen, Schweiz, 9007
    - Research Site
  - Zurich, Schweiz, 8063
    - Research Site
  - Zurich, Schweiz, 8091
    - Research Site
Spanien
- - Madrid, Spanien, 28040
    - Research Site
  - Madrid, Spanien, 28007
    - Research Site
  - Madrid, Spanien, 28029
    - Research Site
- Andalucía
  - Cordoba, Andalucía, Spanien, 14004
    - Research Site
- Aragón
  - Zaragoza, Aragón, Spanien, 50009
    - Research Site
- Cataluña
  - L'Hospitalet de Llobregat, Cataluña, Spanien, 08907
    - Research Site
  - Reus, Cataluña, Spanien, 43204
    - Research Site
Sverige
- - Göteborg, Sverige, 413 45
    - Research Site
  - Lund, Sverige, 222 21
    - Research Site
  - Stockholm, Sverige, 141 86
    - Research Site
  - Stockholm, Sverige, 171 45
    - Research Site
  - Stockholm, Sverige, 111 57
    - Research Site
  - Uddevalla, Sverige, 451 50
    - Research Site
  - Örebro, Sverige, 701 46
    - Research Site
Sydafrika
- - Bloemfontein, Sydafrika, 9301
    - Research Site
- Gauteng
  - Centurion, Gauteng, Sydafrika, 0157
    - Research Site
  - Johannesburg, Gauteng, Sydafrika, 2193
    - Research Site
  - Midrand, Gauteng, Sydafrika, 1685
    - Research Site
  - Sunninghill, Gauteng, Sydafrika, 2157
    - Research Site
- KwaZulu-Natal
  - Amanzimtoti, KwaZulu-Natal, Sydafrika, 4126
    - Research Site
- Western Cape
  - Observatory, Western Cape, Sydafrika, 7925
    - Research Site
  - Paarl, Western Cape, Sydafrika, 7646
    - Research Site
  - Parow, Western Cape, Sydafrika, 7505
    - Research Site
  - Somerset West, Western Cape, Sydafrika, 7130
    - Research Site
Taiwan
- - Kaohsiung, Taiwan, 83301
    - Research Site
  - Taipei, Taiwan, 100
    - Research Site
Tjekkiet
- - Brno, Tjekkiet, 602 00
    - Research Site
  - Brno, Tjekkiet, 603 00
    - Research Site
  - Chomutov, Tjekkiet, 430 02
    - Research Site
  - Hradec Kralove, Tjekkiet, 500 05
    - Research Site
  - Kladno, Tjekkiet, 272 01
    - Research Site
  - Litomerice, Tjekkiet, 412 01
    - Research Site
  - Moravske Budejovice, Tjekkiet, 676 02
    - Research Site
  - Olomouc, Tjekkiet, 775 20
    - Research Site
  - Pardubice, Tjekkiet, 530 02
    - Research Site
  - Plzen, Tjekkiet, 305 99
    - Research Site
  - Praha 2, Tjekkiet, 128 08
    - Research Site
  - Praha 3, Tjekkiet, 130 00
    - Research Site
  - Praha 4, Tjekkiet, 140 21
    - Research Site
  - Praha 5, Tjekkiet, 150 06
    - Research Site
  - Slany, Tjekkiet, 274 01
    - Research Site
  - Svitavy, Tjekkiet, 568 25
    - Research Site
Tyskland
- - Bad Krozingen, Tyskland, 79189
    - Research Site
  - Berlin, Tyskland, 10787
    - Research Site
  - Berlin, Tyskland, 13353
    - Research Site
  - Berlin (Hellersdorf), Tyskland, 12627
    - Research Site
  - Dresden, Tyskland, 01307
    - Research Site
  - Heppenheim, Tyskland, 64646
    - Research Site
  - Homburg, Tyskland, 66421
    - Research Site
  - Köln, Tyskland, 50937
    - Research Site
  - Leipzig, Tyskland, 04103
    - Research Site
  - Magdeburg, Tyskland, 39112
    - Research Site
  - Messkirch, Tyskland, 88605
    - Research Site
  - München, Tyskland, 80638
    - Research Site
  - Witten, Tyskland, 58455
    - Research Site
Ungarn
- - Baja, Ungarn, 6500
    - Research Site
  - Berettyoujfalu, Ungarn, 4100
    - Research Site
  - Budapest, Ungarn, 1085
    - Research Site
  - Eger, Ungarn, 3300
    - Research Site
  - Gyongyos, Ungarn, 3200
    - Research Site
  - Hodmezovasarhely, Ungarn, 6800
    - Research Site
  - Jaszbereny, Ungarn, 5100
    - Research Site
  - Komarom, Ungarn, 2921
    - Research Site
  - Mosonmagyarovar, Ungarn, 9200
    - Research Site
  - Pecs, Ungarn, 7624
    - Research Site
  - Szeged, Ungarn, 6720
    - Research Site
Østrig
- - Salzburg, Østrig, 5020
    - Research Site

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 til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / 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.	Biologisk: Evolocumab Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen Andre navne: Repatha AMG 145 Medicin: Standard of Care Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Eksperimentel: 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.	Biologisk: Evolocumab Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen Andre navne: Repatha AMG 145 Medicin: Standard of Care Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

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

Hjælpsomme links

AmgenTrials clinical trials website

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)

23. april 2013

Primær færdiggørelse (Faktiske)

31. maj 2018

Studieafslutning (Faktiske)

31. maj 2018

Datoer for studieregistrering

Først indsendt

1. maj 2013

Først indsendt, der opfyldte QC-kriterier

15. maj 2013

Først opslået (Skøn)

16. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

20120138
2012-004357-83 (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 Evolocumab

Amgen

Rekruttering

Sammenligning af omfanget, hvormed to evolocumab-lægemiddelprodukter bliver tilgængelige i kroppen efter en enkelt subkutan dosis

Farmakokinetik | Sunde deltagere

Forenede Stater
Amgen

Ikke rekrutterer endnu

Sammenligning af omfanget, hvormed to Evolocumab-lægemiddelprodukter bliver tilgængelige i kroppen efter en enkelt subkutan dosis.

Sunde deltagere
West China Hospital

Rekruttering

CAPER-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS (CAPER-EVO)

Koronararteriesygdom | Koronar

Kina
Nanfang Hospital, Southern Medical University

Ikke rekrutterer endnu

PCSK9 -hæmmere hos akutte iskæmiske slagtilfældepatienter, der gennemgår endovaskulær terapi (PCSK9-PROVE)

Akut iskæmisk slagtilfælde

Kina
First Affiliated Hospital of Fujian Medical University

Rekruttering

PCSK9-hæmmerbehandling til patienter med SPG5

Arvelig spastisk paraplegi type 5

Kina
Hospital General Universitario Gregorio Marañon

Afsluttet

Evolocumab versus LDL-aferese hos patienter med hyperkolesterolæmi

Hyperkolesterolæmi

Spanien
Amgen
Organization of Teratology Information Specialists (OTIS) Research Center...

Afsluttet

Evolocumab graviditetseksponeringsregister

Hyperkolesterolæmi; ASCVD; Graviditet
Amgen

Afsluttet

Undersøgelse for at vurdere ved hjemmebrug af administration af Evolocumab (AMG 145) ved hjælp af enten en automatiseret minidoser eller en fyldt autoinjektor/pen

Blandet dyslipidæmi | Primær hyperkolesterolæmi

Forenede Stater, Canada
Rigshospitalet, Denmark

Trukket tilbage

Vaskulær inflammation og kolesterolsænkende terapi

Lipidsænkende, vaskulær betændelse

Danmark
Amgen

Afsluttet

Undersøgelse for at vurdere hjemmebrug af Evolocumab (AMG 145) ved brug af en forfyldt sprøjte eller en forudfyldt autoinjektor/pen

Blandet dyslipidæmi | Primær hyperkolesterolæmi

Forenede Stater, Canada

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Evolocumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer