Clinical trial NCT01854918: Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Official title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia and Mixed Dyslipidemia
Keywords: High cholesterol
Raised cholesterol
Cholesterol
Elevated Cholesterol
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-05-16
Enrollment: 3681
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
Secondary outcomes:
measure: Percent Change From Baseline in LDL-C at Weeks 48 and 104
timeFrame: Baseline of the parent study and weeks 48 amd 104
measure: Change From Baseline in LDL-C at Weeks 48 and 104
timeFrame: Baseline of the parent study and weeks 48 amd 104
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Carmichael
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Thousand Oaks
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Tustin
country: United States
facility: Research Site
state: California
city: Ventura
country: United States
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state: California
city: Littleton
country: United States
facility: Research Site
state: Colorado
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Melbourne
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Ponte Vedra
country: United States
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state: Florida
city: Port Charlotte
country: United States
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state: Florida
city: Sanford
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Atlanta
country: United States
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state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Gainesville
country: United States
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state: Georgia
city: Savannah
country: United States
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city: Chicago
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state: Illinois
city: Sterling
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city: Indianapolis
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state: Indiana
city: Munster
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city: Iowa City
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city: Kansas City
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city: Lexington
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city: Louisville
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state: Kentucky
city: Monroe
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city: Auburn
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state: Maine
city: Bangor
country: United States
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state: Maine
city: Portland
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city: Bethesda
country: United States
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city: Columbia
country: United States
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city: Towson
country: United States
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state: Maryland
city: Ayer
country: United States
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city: Quincy
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city: Edina
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city: Tupelo
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city: Las Vegas
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city: Manlius
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city: New Windsor
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city: New York
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city: Rochester
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city: Cincinnati
country: United States
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city: Cincinnati
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city: Cincinnati
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city: Cleveland
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city: Dayton
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city: Mansfield
country: United States
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city: Marion
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city: Sandusky
country: United States
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state: Ohio
city: Norman
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
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state: Oklahoma
city: Hillsboro
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city: Duncansville
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state: Pennsylvania
city: Lansdale
country: United States
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city: Pittsburgh
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city: York
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state: Pennsylvania
city: Anderson
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state: South Carolina
city: Charleston
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state: South Carolina
city: Mount Pleasant
country: United States
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Rapid City
country: United States
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state: South Dakota
city: Jackson
country: United States
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city: Nashville
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city: Austin
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city: Dallas
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city: Richmond
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city: Suffolk
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city: Renton
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city: Seattle
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: Camperdown
country: Australia
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state: New South Wales
city: Maroubra
country: Australia
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state: New South Wales
city: Sydney
country: Australia
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state: New South Wales
city: Sydney
country: Australia
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state: New South Wales
city: Auchenflower
country: Australia
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state: Queensland
city: Carina Heights
country: Australia
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state: Queensland
city: Sherwood
country: Australia
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state: Queensland
city: Woolloongabba
country: Australia
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state: Queensland
city: Ashford
country: Australia
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state: South Australia
city: Fullarton
country: Australia
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state: South Australia
city: Heidelberg Heights
country: Australia
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state: Victoria
city: Melbourne
country: Australia
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state: Victoria
city: Perth
country: Australia
facility: Research Site
state: Western Australia
city: Salzburg
country: Austria
facility: Research Site
city: Anthée
country: Belgium
facility: Research Site
city: Blankenberge
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Chênée
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Gozee
country: Belgium
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city: Gribomont
country: Belgium
facility: Research Site
city: Halen
country: Belgium
facility: Research Site
city: Ham
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: La Louvière
country: Belgium
facility: Research Site
city: Linkebeek
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Tessenderlo
country: Belgium
facility: Research Site
city: Tremelo
country: Belgium
facility: Research Site
city: Vilvoorde
country: Belgium
facility: Research Site
city: Burnaby
country: Canada
facility: Research Site
state: British Columbia
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Research Site
state: Ontario
city: Sarnia
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: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Woodstock
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Research Site
state: Quebec
city: Granby
country: Canada
facility: Research Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Lachine
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Chomutov
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Kladno
country: Czechia
facility: Research Site
city: Litomerice
country: Czechia
facility: Research Site
city: Moravske Budejovice
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 3
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 5
country: Czechia
facility: Research Site
city: Slany
country: Czechia
facility: Research Site
city: Svitavy
country: Czechia
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Aarhus N
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Brest Cedex 2
country: France
facility: Research Site
city: Bron
country: France
facility: Research Site
city: Caen Cedex 9
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Montpellier cedex 05
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Paris Cedex 12
country: France
facility: Research Site
city: Paris Cedex 13
country: France
facility: Research Site
city: Vénissieux
country: France
facility: Research Site
city: Bad Krozingen
country: Germany
facility: Research Site
city: Berlin (Hellersdorf)
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Heppenheim
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Messkirch
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: New Territories
country: Hong Kong
facility: Research Site
city: Baja
country: Hungary
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city: Berettyoujfalu
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Eger
country: Hungary
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city: Gyongyos
country: Hungary
facility: Research Site
city: Hodmezovasarhely
country: Hungary
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city: Jaszbereny
country: Hungary
facility: Research Site
city: Komarom
country: Hungary
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city: Mosonmagyarovar
country: Hungary
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city: Pecs
country: Hungary
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city: Szeged
country: Hungary
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city: Bologna
country: Italy
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city: Cagliari
country: Italy
facility: Research Site
city: Chieti
country: Italy
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city: Cinisello Balsamo (MI)
country: Italy
facility: Research Site
city: Ferrara
country: Italy
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city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Perugia
country: Italy
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city: Pisa
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Noda-shi
country: Japan
facility: Research Site
state: Chiba
city: Fukuoka-shi
country: Japan
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state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyusyu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Koriyama-shi
country: Japan
facility: Research Site
state: Fukushima
city: Koriyama-shi
country: Japan
facility: Research Site
state: Fukushima
city: Koriyama-shi
country: Japan
facility: Research Site
state: Fukushima
city: Koriyama-shi
country: Japan
facility: Research Site
state: Fukushima
city: Koriyama-shi
country: Japan
facility: Research Site
state: Fukushima
city: Maebashi-shi
country: Japan
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state: Gunma
city: Takasaki-shi
country: Japan
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state: Gunma
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo-shi
country: Japan
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state: Hokkaido
city: Sapporo-shi
country: Japan
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state: Hokkaido
city: Tsuchiura-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Morioka-shi
country: Japan
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state: Iwate
city: Takamatsu-shi
country: Japan
facility: Research Site
state: Kagawa
city: Takamatsu-shi
country: Japan
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state: Kagawa
city: Yokohama-shi
country: Japan
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state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto
city: Sendai-shi
country: Japan
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state: Miyagi
city: Sendai-shi
country: Japan
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state: Miyagi
city: Sendai-shi
country: Japan
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city: Tomigusuku-shi
country: Japan
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city: Ibaraki-shi
country: Japan
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city: Toyonaka-shi
country: Japan
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state: Osaka
city: Koshigaya-shi
country: Japan
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city: Niiza-shi
country: Japan
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city: Arakawa-ku
country: Japan
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city: Chiyoda-ku
country: Japan
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city: Chofu-shi
country: Japan
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city: Edogawa-ku
country: Japan
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country: Japan
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city: Katsushika-ku
country: Japan
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country: Japan
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city: Minato-ku
country: Japan
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city: Minato-ku
country: Japan
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city: Ota-ku
country: Japan
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country: Japan
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country: Japan
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city: Shinagawa-ku
country: Japan
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state: Tokyo
city: Shinagawa-ku
country: Japan
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city: Shinagawa-ku
country: Japan
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city: Shinagawa-ku
country: Japan
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city: Toshima-ku
country: Japan
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state: Tokyo
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country: Korea, Republic of
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country: Korea, Republic of
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Norway
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country: Norway
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country: Poland
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: South Africa
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city: Johannesburg
country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: Spain
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city: Zaragoza
country: Spain
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city: L'Hospitalet de Llobregat
country: Spain
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country: Spain
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city: Madrid
country: Spain
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country: Spain
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country: Spain
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country: Sweden
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country: Sweden
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country: Sweden
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country: Sweden
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country: Sweden
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country: Sweden
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country: Sweden
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country: Switzerland
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country: Switzerland
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country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Muensterlingen
country: Switzerland
facility: Research Site
city: Reinach
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Doncaster
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Telford
country: United Kingdom
facility: Research Site
city: Wakefield
country: United Kingdom
facility: Research Site
city: West Bromwich
country: United Kingdom
facility: Research Site
city: Whitby
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.