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Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

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ClinicalTrials.gov Identifier: NCT02304484
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Biological: Evolocumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 770 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
Actual Study Start Date : November 24, 2014
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arm Intervention/treatment
Experimental: Evolocumab
Participants received 420 mg evolocumab once a month for up to 2 years.
Biological: Evolocumab
Administered by subcutaneous injection once a month
Other Names:
  • AMG 145
  • Repatha




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks. ]

    The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE.

    An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.



Secondary Outcome Measures :
  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed week 80 of study 20120153 (NCT01813422).

Exclusion Criteria:

  • Did not complete investigational product in the 20120153 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304484


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Locations
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United States, Alabama
Research Site
Huntsville, Alabama, United States, 35801
Research Site
Mobile, Alabama, United States, 36608
United States, California
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Long Beach, California, United States, 90822
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San Diego, California, United States, 92161
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Torrance, California, United States, 90502
United States, Florida
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Jacksonville, Florida, United States, 32216
United States, Indiana
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Munster, Indiana, United States, 46321
United States, Kentucky
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Lexington, Kentucky, United States, 40536
United States, Louisiana
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Covington, Louisiana, United States, 70433
United States, Maryland
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Bethesda, Maryland, United States, 20814
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Columbia, Maryland, United States, 21044
United States, Michigan
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Bay City, Michigan, United States, 48708
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Midland, Michigan, United States, 48670
United States, Minnesota
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Duluth, Minnesota, United States, 55805
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Saint Cloud, Minnesota, United States, 56303
United States, Missouri
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Columbia, Missouri, United States, 65212
United States, New Jersey
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Ridgewood, New Jersey, United States, 07450
United States, North Dakota
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Fargo, North Dakota, United States, 58122
United States, Ohio
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Canton, Ohio, United States, 44710
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Toledo, Ohio, United States, 43614
United States, Tennessee
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Oak Ridge, Tennessee, United States, 37830
United States, Texas
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Amarillo, Texas, United States, 79106
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Dallas, Texas, United States, 75216
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Wichita Falls, Texas, United States, 76301
Argentina
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La Plata, Buenos Aires, Argentina, B1906EHD
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Cordoba, Córdoba, Argentina, X5016KEH
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Córdoba, Argentina, X5003DCE
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Córdoba, Argentina, X5021FPI
Australia, New South Wales
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Liverpool, New South Wales, Australia, 2170
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New Lambton Heights, New South Wales, Australia, 2305
Australia, Queensland
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Chermside, Queensland, Australia, 4032
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Herston, Queensland, Australia, 4029
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
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Fullarton, South Australia, Australia, 5063
Australia, Victoria
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Epping, Victoria, Australia, 3076
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Footscray, Victoria, Australia, 3011
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Belgium
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Antwerpen, Belgium, 2020
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Edegem, Belgium, 2650
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Genk, Belgium, 3600
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Hasselt, Belgium, 3500
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Lodelinsart, Belgium, 6042
Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
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São Paulo, Brazil, 05403-000
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
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Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
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London, Ontario, Canada, N6A 5A5
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Toronto, Ontario, Canada, M5B 1W8
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Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
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Laval, Quebec, Canada, H7M 3L9
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Montreal, Quebec, Canada, H1T 2M4
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Québec, Quebec, Canada, G1V 4G5
Chile
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Temuco, Cautín, Chile, 4781156
Czechia
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Brno, Czechia, 625 00
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Hradec Kralove, Czechia, 500 05
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Praha 2, Czechia, 128 08
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Zlin, Czechia, 762 75
France
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Besancon cedex, France, 25030
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Chambray les Tours, France, 37170
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Marseille cedex 5, France, 13385
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Paris, France, 75015
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Pessac Cedex, France, 33604
Germany
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Essen, Germany, 45147
Greece
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Athens, Greece, 11527
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Athens, Greece, 14561
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Heraklion, Greece, 71110
Hungary
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Budapest, Hungary, 1023
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Budapest, Hungary, 1122
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Budapest, Hungary, 1134
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Debrecen, Hungary, 4032
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Szeged, Hungary, 6725
Iceland
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Reykjavik, Iceland, 101
Ireland
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Galway, Ireland
Israel
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Hadera, Israel, 38100
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Jerusalem, Israel, 91031
Italy
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Novara, Italy, 28100
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Rozzano MI, Italy, 20089
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Sesto San Giovanni (MI), Italy, 20099
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Torino, Italy, 10154
Korea, Republic of
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Daejeon, Korea, Republic of, 301-723
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
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Seoul, Korea, Republic of, 130-872
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Seoul, Korea, Republic of, 156-707
Malaysia
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Kuantan, Pahang, Malaysia, 25100
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Penang, Malaysia, 10050
Mexico
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Guadalajara, Jalisco, Mexico, 44670
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San Luis Potosi, San Luis Potosí, Mexico, 78240
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Culiacan, Sinaloa, Mexico, 80230
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Aguascalientes, Mexico, 20230
Netherlands
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Alkmaar, Netherlands, 1815 JD
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Amsterdam, Netherlands, 1081 HV
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Amsterdam, Netherlands, 1091 AC
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Leeuwarden, Netherlands, 8934 AD
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Nijmegen, Netherlands, 6532 SZ
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Rotterdam, Netherlands, 3079 DZ
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Tilburg, Netherlands, 5042 AD
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Utrecht, Netherlands, 3508 GZ
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Zwolle, Netherlands, 8025 AB
Norway
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Oslo, Norway, 0424
Poland
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Chrzanow, Poland, 32-500
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Kedzierzyn Kozle, Poland, 47-200
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Krakow, Poland, 31-202
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Krakow, Poland, 31-501
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Lodz, Poland, 90-549
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Warszawa, Poland, 04-628
Russian Federation
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Kemerovo, Russian Federation, 650002
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Moscow, Russian Federation, 101990
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Moscow, Russian Federation, 119991
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Moscow, Russian Federation, 121552
South Africa
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Centurion, Gauteng, South Africa, 0157
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Sunninghill, Gauteng, South Africa, 2157
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Kuils River, Western Cape, South Africa, 7580
Spain
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Malaga, Andalucía, Spain, 29010
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Gijon, Asturias, Spain, 33394
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Barcelona, Cataluña, Spain, 08035
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L Hospitalet De Llobregat, Cataluña, Spain, 08907
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Madrid, Spain, 28034
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Madrid, Spain, 28046
Sweden
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Göteborg, Sweden, 413 45
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Stockholm, Sweden, 171 76
Switzerland
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Geneva 14, Switzerland, 1211
Taiwan
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New Taipei, Taiwan, 251
United Kingdom
Research Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Statistical Analysis Plan  [PDF] June 9, 2017
Study Protocol  [PDF] December 22, 2014


Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02304484     History of Changes
Other Study ID Numbers: 20140128
2014-001524-30 ( EudraCT Number )
First Posted: December 2, 2014    Key Record Dates
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs