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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05378529




Registration number
NCT05378529
Ethics application status
Date submitted
2/05/2022
Date registered
18/05/2022

Titles & IDs
Public title
A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)
Scientific title
A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease
Secondary ID [1] 0 0
20210057
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Lp(a) Screening

Other: Participants with history of ASCVD - Participants with history of ASCVD with known or unknown Lp(a) values.


Other interventions: Lp(a) Screening
Participants will provide demographic information and have a blood draw for Lp(a) levels if they are unknown.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with elevated Lp(a) with documented history of ASCVD
Timepoint [1] 0 0
Up to approximately 2 weeks
Secondary outcome [1] 0 0
Lp(a) Levels
Timepoint [1] 0 0
Up to approximately 2 weeks
Secondary outcome [2] 0 0
Lp(a) Levels stratified by demographics and region
Timepoint [2] 0 0
Up to approximately 2 weeks

Eligibility
Key inclusion criteria
* Signed informed consent
* History of ASCVD
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants known to be currently receiving investigational drug in a clinical study
* Participants with a diagnosis of end-stage renal disease or requiring dialysis
* Participants who have received lipoprotein apheresis to reduce Lp(a) within 3 months prior to enrollment

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
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Liverpool Hospital - Liverpool
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Holdsworth House Medical Practice - Sydney
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Wollongong Hospital - Wollongong
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Advara HeartCare Wesley - Auchenflower
Recruitment hospital [8] 0 0
Advara HeartCare Bundaberg - Bundaberg
Recruitment hospital [9] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [10] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [11] 0 0
Dr Heart Pty Ltd - Woolloongabba
Recruitment hospital [12] 0 0
Nightingale Research - Adelaide
Recruitment hospital [13] 0 0
SA Heart - Ashford
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Advara HeartCare Leabrook - Leabrook
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Royal Hobart Hospital - Hobart
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Advara HeartCare Berwick - Berwick
Recruitment hospital [17] 0 0
Advara HeartCare Ringwood - Bundoora
Recruitment hospital [18] 0 0
The Cardiologists Proprietary Limited - Epping
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Barwon Health Geelong Hospital - Geelong
Recruitment hospital [20] 0 0
Advara HeartCare Joondalup - Joondalup
Recruitment hospital [21] 0 0
Clinitrials - Murdoch
Recruitment hospital [22] 0 0
Linear Clinical Research Limited - Nedlands
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2605 - Garran
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2050 - Camperdown
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2139 - Concord
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2170 - Liverpool
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2010 - Sydney
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2500 - Wollongong
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4066 - Auchenflower
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4670 - Bundaberg
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4029 - Herston
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4064 - Milton
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4102 - Woolloongabba
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5000 - Adelaide
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5068 - Leabrook
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7000 - Hobart
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6009 - Nedlands
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Szekesfehervar
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Hungary
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Szolnok
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Hungary
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Iceland
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Caserta
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Italy
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Catania
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Italy
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Catanzaro
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Ferrara
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Italy
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Firenze
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Italy
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Genova
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Milano
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Palermo
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Rivoli
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Italy
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Roma
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Italy
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Rozzano MI
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Italy
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Salerno
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Italy
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Sesto San Giovanni (MI)
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Torino
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Japan
State/province [246] 0 0
Fukuoka
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Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Iwate
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Japan
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Kagawa
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Klaipeda
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Lithuania
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Mexico
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Mexico
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Mexico
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Mexico
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Amsterdam
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Apeldoorn
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Arnhem
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Bergen op Zoom
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Delft
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Groningen
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Hoofddorp
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Hoorn
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Leiden
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Netherlands
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Leiderdorp
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Netherlands
State/province [309] 0 0
Nijmegen
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Netherlands
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Rotterdam
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Netherlands
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Sneek
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Netherlands
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The Hague
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Tiel
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Tilburg
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Netherlands
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Utrecht
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Netherlands
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Oslo
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Norway
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Belchatow
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Poland
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Bielsko-Biala
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Poland
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Chrzanow
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Poland
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Dabrowa Gornicza
Country [323] 0 0
Poland
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Gdansk
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Poland
State/province [324] 0 0
Gizycko
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Poland
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Kedzierzyn Kozle
Country [326] 0 0
Poland
State/province [326] 0 0
Krakow
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Poland
State/province [327] 0 0
Lodz
Country [328] 0 0
Poland
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Lublin
Country [329] 0 0
Poland
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Poznan
Country [330] 0 0
Poland
State/province [330] 0 0
Sztum
Country [331] 0 0
Poland
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Tychy
Country [332] 0 0
Poland
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Warszawa
Country [333] 0 0
Poland
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Wroclaw
Country [334] 0 0
Poland
State/province [334] 0 0
Zamosc
Country [335] 0 0
Poland
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Zgierz
Country [336] 0 0
Portugal
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Amadora
Country [337] 0 0
Portugal
State/province [337] 0 0
Aveiro
Country [338] 0 0
Portugal
State/province [338] 0 0
Braga
Country [339] 0 0
Portugal
State/province [339] 0 0
Carnaxide
Country [340] 0 0
Portugal
State/province [340] 0 0
Coimbra
Country [341] 0 0
Portugal
State/province [341] 0 0
Guimaraes
Country [342] 0 0
Portugal
State/province [342] 0 0
Matosinhos
Country [343] 0 0
Portugal
State/province [343] 0 0
Santa Maria da Feira
Country [344] 0 0
Portugal
State/province [344] 0 0
Setubal
Country [345] 0 0
Portugal
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Vila Nova de Gaia
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Romania
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Baia Mare
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Buzau
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Romania
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Pitesti
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Romania
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Targu Mures
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Romania
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Targu-Mures
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Romania
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Timisoara
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Slovakia
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Bardejov
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Slovakia
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Bratislava
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Slovakia
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Brezno
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Slovakia
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Slovakia
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Klastor pod Znievom
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Slovakia
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Kosice
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Slovakia
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Lucenec
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Slovakia
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Moldava nad Bodvou
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Slovakia
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Slovakia
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Nitra
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Slovakia
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Nove Zamky
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Slovakia
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Piestany
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Slovakia
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Presov
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Slovakia
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Rimavska Sobota
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Slovakia
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Slovakia
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Svidnik
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Slovakia
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Slovakia
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Trencin
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Spain
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Spain
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Aragón
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Spain
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Spain
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Spain
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Cataluña
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Spain
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Spain
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Galicia
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Spain
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Murcia
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Spain
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Falun
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Lund
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Malmo
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Sweden
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Bern
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Switzerland
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Switzerland
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Lugano
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Switzerland
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Sankt Gallen
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Switzerland
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Zuerich
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Hualien
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Taiwan
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Kaohsiung
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Taiwan
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Taiwan
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Taichung
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Taiwan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Adana
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Turkey
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Turkey
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Turkey
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Antalya
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Turkey
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Aydin
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Mersin
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Turkey
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Mugla
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Turkey
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Samsun
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Turkey
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Van
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United Kingdom
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Aberdeen
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Blackpool
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United Kingdom
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Bradford
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United Kingdom
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Bristol
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United Kingdom
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Chichester
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United Kingdom
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Craigavon
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United Kingdom
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Enfield
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United Kingdom
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Exeter
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United Kingdom
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Glasgow
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United Kingdom
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Harefield
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United Kingdom
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High Wycombe
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United Kingdom
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Hull
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United Kingdom
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Inverness
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United Kingdom
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Leicester
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United Kingdom
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Lincoln
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle
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United Kingdom
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Nottingham
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United Kingdom
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Penarth
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United Kingdom
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Poole
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United Kingdom
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Preston
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United Kingdom
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Rochdale
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United Kingdom
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Sandbach
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United Kingdom
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Stevenage
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United Kingdom
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Telford
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United Kingdom
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Wilts
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United Kingdom
State/province [442] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.