Clinical trial NCT02304484: Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Official title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.
Secondary outcomes:
measure: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Long Beach
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Munster
country: United States
facility: Research Site
state: Indiana
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Covington
country: United States
facility: Research Site
state: Louisiana
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Columbia
country: United States
facility: Research Site
state: Maryland
city: Bay City
country: United States
facility: Research Site
state: Michigan
city: Midland
country: United States
facility: Research Site
state: Michigan
city: Duluth
country: United States
facility: Research Site
state: Minnesota
city: Saint Cloud
country: United States
facility: Research Site
state: Minnesota
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Ridgewood
country: United States
facility: Research Site
state: New Jersey
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oak Ridge
country: United States
facility: Research Site
state: Tennessee
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Research Site
state: Texas
city: La Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Research Site
state: Córdoba
city: Córdoba
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: Liverpool
country: Australia
facility: Research Site
state: New South Wales
city: New Lambton Heights
country: Australia
facility: Research Site
state: New South Wales
city: Chermside
country: Australia
facility: Research Site
state: Queensland
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Fullarton
country: Australia
facility: Research Site
state: South Australia
city: Epping
country: Australia
facility: Research Site
state: Victoria
city: Footscray
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Antwerpen
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Lodelinsart
country: Belgium
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. Johns
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Québec
country: Canada
facility: Research Site
state: Quebec
city: Temuco
country: Chile
facility: Research Site
state: Cautín
city: Brno
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Besancon cedex
country: France
facility: Research Site
city: Chambray les Tours
country: France
facility: Research Site
city: Marseille cedex 5
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pessac Cedex
country: France
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Reykjavik
country: Iceland
facility: Research Site
city: Galway
country: Ireland
facility: Research Site
city: Hadera
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Novara
country: Italy
facility: Research Site
city: Rozzano MI
country: Italy
facility: Research Site
city: Sesto San Giovanni (MI)
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Kuantan
country: Malaysia
facility: Research Site
state: Pahang
city: Penang
country: Malaysia
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: San Luis Potosi
country: Mexico
facility: Research Site
state: San Luis Potosí
city: Culiacan
country: Mexico
facility: Research Site
state: Sinaloa
city: Aguascalientes
country: Mexico
facility: Research Site
city: Alkmaar
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Chrzanow
country: Poland
facility: Research Site
city: Kedzierzyn Kozle
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Centurion
country: South Africa
facility: Research Site
state: Gauteng
city: Sunninghill
country: South Africa
facility: Research Site
state: Gauteng
city: Kuils River
country: South Africa
facility: Research Site
state: Western Cape
city: Malaga
country: Spain
facility: Research Site
state: Andalucía
city: Gijon
country: Spain
facility: Research Site
state: Asturias
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: L Hospitalet De Llobregat
country: Spain
facility: Research Site
state: Cataluña
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Geneva 14
country: Switzerland
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: