Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
NCT ID: NCT02304484
Last Updated: 2019-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
770 participants
INTERVENTIONAL
2014-11-24
2018-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Evolocumab
Participants received 420 mg evolocumab once a month for up to 2 years.
Evolocumab
Administered by subcutaneous injection once a month
Interventions
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Evolocumab
Administered by subcutaneous injection once a month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Long Beach, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Jacksonville, Florida, United States
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Munster, Indiana, United States
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Lexington, Kentucky, United States
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Covington, Louisiana, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Bay City, Michigan, United States
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Midland, Michigan, United States
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Duluth, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Columbia, Missouri, United States
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Ridgewood, New Jersey, United States
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Fargo, North Dakota, United States
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Canton, Ohio, United States
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Toledo, Ohio, United States
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Oak Ridge, Tennessee, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Wichita Falls, Texas, United States
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La Plata, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Liverpool, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Chermside, Queensland, Australia
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Herston, Queensland, Australia
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Adelaide, South Australia, Australia
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Fullarton, South Australia, Australia
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Epping, Victoria, Australia
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Footscray, Victoria, Australia
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Nedlands, Western Australia, Australia
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Antwerp, , Belgium
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Edegem, , Belgium
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Genk, , Belgium
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Hasselt, , Belgium
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Lodelinsart, , Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Temuco, Cautín, Chile
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Zlín, , Czechia
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Besançon, , France
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Chambray-lès-Tours, , France
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Marseille, , France
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Paris, , France
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Pessac, , France
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Essen, , Germany
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Athens, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Reykjavik, , Iceland
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Galway, , Ireland
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Hadera, , Israel
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Jerusalem, , Israel
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Novara, , Italy
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Rozzano MI, , Italy
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Sesto San Giovanni (MI), , Italy
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Torino, , Italy
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Kuantan, Pahang, Malaysia
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George Town, , Malaysia
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Guadalajara, Jalisco, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Culiacán, Sinaloa, Mexico
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Aguascalientes, , Mexico
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Alkmaar, , Netherlands
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Leeuwarden, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Utrecht, , Netherlands
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Zwolle, , Netherlands
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Oslo, , Norway
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Chrzanów, , Poland
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Kędzierzyn-Koźle, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Centurion, Gauteng, South Africa
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Sunninghill, Gauteng, South Africa
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Kuils River, Western Cape, South Africa
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Daejeon, , South Korea
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Seongnam-si, Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Málaga, Andalusia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Gijón, Principality of Asturias, Spain
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Madrid, , Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Geneva, , Switzerland
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New Taipei City, , Taiwan
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Newcastle upon Tyne, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2014-001524-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20140128
Identifier Type: -
Identifier Source: org_study_id
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