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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01764633




Registration number
NCT01764633
Ethics application status
Date submitted
8/01/2013
Date registered
9/01/2013
Date last updated
28/05/2024

Titles & IDs
Public title
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
Secondary ID [1] 0 0
2014/01/004324
Secondary ID [2] 0 0
20110118
Universal Trial Number (UTN)
Trial acronym
FOURIER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Evolocumab
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.

Experimental: Evolocumab - Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.


Treatment: Other: Evolocumab
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Treatment: Drugs: Placebo
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization
Timepoint [1] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [1] 0 0
Time to Cardiovascular Death, Myocardial Infarction, or Stroke
Timepoint [1] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [2] 0 0
Time to Cardiovascular Death
Timepoint [2] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [3] 0 0
Time to All Cause Death
Timepoint [3] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [4] 0 0
Time to First Myocardial Infarction
Timepoint [4] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [5] 0 0
Time to First Stroke
Timepoint [5] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [6] 0 0
Time to First Coronary Revascularization
Timepoint [6] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [7] 0 0
Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure
Timepoint [7] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.
Secondary outcome [8] 0 0
Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack
Timepoint [8] 0 0
Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.

Eligibility
Key inclusion criteria
* Male or female = 40 to = 85 years of age
* History of clinically evident cardiovascular disease at high risk for a recurrent event
* Fasting low-density lipoprotein cholesterol (LDL-C) = 70 mg/dL (= 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) = 100 mg/dL (> 2.6 mmol/L)
* Fasting triglycerides = 400 mg/dL (4.5 mmol/L)
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
* Uncontrolled hypertension
* Uncontrolled or recurrent ventricular tachycardia
* Untreated hyperthyroidism or hypothyroidism
* Homozygous familial hypercholesterolemia
* LDL or plasma apheresis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
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Research Site - Woden
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4102 - Woolloongabba
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4066 - Auchenflower
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4029 - Herston
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5000 - Adelaide
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5035 - Ashford
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3128 - Box Hill
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6009 - Nedlands
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State/province [194] 0 0
Turku
Country [195] 0 0
France
State/province [195] 0 0
Besançon Cedex
Country [196] 0 0
France
State/province [196] 0 0
Brest Cedex 2
Country [197] 0 0
France
State/province [197] 0 0
Chambray les Tours
Country [198] 0 0
France
State/province [198] 0 0
Clermont Ferrand
Country [199] 0 0
France
State/province [199] 0 0
Créteil
Country [200] 0 0
France
State/province [200] 0 0
Dijon cedex
Country [201] 0 0
France
State/province [201] 0 0
Le Coudray
Country [202] 0 0
France
State/province [202] 0 0
Lille Cedex
Country [203] 0 0
France
State/province [203] 0 0
Lyon
Country [204] 0 0
France
State/province [204] 0 0
Marseille Cedex 08
Country [205] 0 0
France
State/province [205] 0 0
Metz cedex 03
Country [206] 0 0
France
State/province [206] 0 0
Montpellier cedex 05
Country [207] 0 0
France
State/province [207] 0 0
Montpellier cedex 5
Country [208] 0 0
France
State/province [208] 0 0
Nantes Cedex 1
Country [209] 0 0
France
State/province [209] 0 0
Nantes Cedex 2
Country [210] 0 0
France
State/province [210] 0 0
Nice
Country [211] 0 0
France
State/province [211] 0 0
Nimes
Country [212] 0 0
France
State/province [212] 0 0
Orleans
Country [213] 0 0
France
State/province [213] 0 0
Paris
Country [214] 0 0
France
State/province [214] 0 0
Pau
Country [215] 0 0
France
State/province [215] 0 0
Perpignan Cedex
Country [216] 0 0
France
State/province [216] 0 0
Pessac Cedex
Country [217] 0 0
France
State/province [217] 0 0
Poitiers
Country [218] 0 0
France
State/province [218] 0 0
Reims cedex
Country [219] 0 0
France
State/province [219] 0 0
Rennes
Country [220] 0 0
France
State/province [220] 0 0
Saint Priest en Jarez
Country [221] 0 0
France
State/province [221] 0 0
Strasbourg
Country [222] 0 0
France
State/province [222] 0 0
Toulouse Cedex 9
Country [223] 0 0
France
State/province [223] 0 0
Vandoeuvre les Nancy
Country [224] 0 0
France
State/province [224] 0 0
Vesoul
Country [225] 0 0
Germany
State/province [225] 0 0
Bad Krozingen
Country [226] 0 0
Germany
State/province [226] 0 0
Berlin
Country [227] 0 0
Germany
State/province [227] 0 0
Bochum
Country [228] 0 0
Germany
State/province [228] 0 0
Demmin
Country [229] 0 0
Germany
State/province [229] 0 0
Dortmund
Country [230] 0 0
Germany
State/province [230] 0 0
Dresden
Country [231] 0 0
Germany
State/province [231] 0 0
Düsseldorf
Country [232] 0 0
Germany
State/province [232] 0 0
Frankfurt am Main
Country [233] 0 0
Germany
State/province [233] 0 0
Giessen
Country [234] 0 0
Germany
State/province [234] 0 0
Hamburg
Country [235] 0 0
Germany
State/province [235] 0 0
Hannover
Country [236] 0 0
Germany
State/province [236] 0 0
Heidelberg
Country [237] 0 0
Germany
State/province [237] 0 0
Ingelheim
Country [238] 0 0
Germany
State/province [238] 0 0
Kassel
Country [239] 0 0
Germany
State/province [239] 0 0
Köln
Country [240] 0 0
Germany
State/province [240] 0 0
Lahr
Country [241] 0 0
Germany
State/province [241] 0 0
Leipzig
Country [242] 0 0
Germany
State/province [242] 0 0
Limburg
Country [243] 0 0
Germany
State/province [243] 0 0
Magdeburg
Country [244] 0 0
Germany
State/province [244] 0 0
Mainz
Country [245] 0 0
Germany
State/province [245] 0 0
Mannheim
Country [246] 0 0
Germany
State/province [246] 0 0
Marburg
Country [247] 0 0
Germany
State/province [247] 0 0
München
Country [248] 0 0
Germany
State/province [248] 0 0
Regensburg
Country [249] 0 0
Germany
State/province [249] 0 0
Stuttgart
Country [250] 0 0
Germany
State/province [250] 0 0
Ulm
Country [251] 0 0
Germany
State/province [251] 0 0
Witten
Country [252] 0 0
Germany
State/province [252] 0 0
Wuppertal
Country [253] 0 0
Greece
State/province [253] 0 0
Alexandroupoli
Country [254] 0 0
Greece
State/province [254] 0 0
Athens
Country [255] 0 0
Greece
State/province [255] 0 0
Chalkida
Country [256] 0 0
Greece
State/province [256] 0 0
Heraklion
Country [257] 0 0
Greece
State/province [257] 0 0
Ioannina
Country [258] 0 0
Greece
State/province [258] 0 0
Larissa
Country [259] 0 0
Greece
State/province [259] 0 0
Nikaia, Piraeus
Country [260] 0 0
Greece
State/province [260] 0 0
Piraeus
Country [261] 0 0
Greece
State/province [261] 0 0
Rhodes
Country [262] 0 0
Greece
State/province [262] 0 0
Thessaloniki
Country [263] 0 0
Hong Kong
State/province [263] 0 0
Hong Kong
Country [264] 0 0
Hong Kong
State/province [264] 0 0
New Territories
Country [265] 0 0
Hungary
State/province [265] 0 0
Balatonfured
Country [266] 0 0
Hungary
State/province [266] 0 0
Bekescsaba
Country [267] 0 0
Hungary
State/province [267] 0 0
Berettyoujfalu
Country [268] 0 0
Hungary
State/province [268] 0 0
Budapest
Country [269] 0 0
Hungary
State/province [269] 0 0
Cegled
Country [270] 0 0
Hungary
State/province [270] 0 0
Debrecen
Country [271] 0 0
Hungary
State/province [271] 0 0
Gyongyos
Country [272] 0 0
Hungary
State/province [272] 0 0
Gyula
Country [273] 0 0
Hungary
State/province [273] 0 0
Kaposvar
Country [274] 0 0
Hungary
State/province [274] 0 0
Kecskemet
Country [275] 0 0
Hungary
State/province [275] 0 0
Komarom
Country [276] 0 0
Hungary
State/province [276] 0 0
Miskolc
Country [277] 0 0
Hungary
State/province [277] 0 0
Nyiregyhaza
Country [278] 0 0
Hungary
State/province [278] 0 0
Pecs
Country [279] 0 0
Hungary
State/province [279] 0 0
Szeged
Country [280] 0 0
Hungary
State/province [280] 0 0
Szekszard
Country [281] 0 0
Hungary
State/province [281] 0 0
Szolnok
Country [282] 0 0
Hungary
State/province [282] 0 0
Zalaegerszeg
Country [283] 0 0
Iceland
State/province [283] 0 0
Kopavogur
Country [284] 0 0
Iceland
State/province [284] 0 0
Reykjavik
Country [285] 0 0
India
State/province [285] 0 0
Andhra Pradesh
Country [286] 0 0
India
State/province [286] 0 0
Delhi
Country [287] 0 0
India
State/province [287] 0 0
Gujarat
Country [288] 0 0
India
State/province [288] 0 0
Haryana
Country [289] 0 0
India
State/province [289] 0 0
Karnataka
Country [290] 0 0
India
State/province [290] 0 0
Maharashtra
Country [291] 0 0
India
State/province [291] 0 0
Uttar Pradesh
Country [292] 0 0
India
State/province [292] 0 0
West Bengal
Country [293] 0 0
Ireland
State/province [293] 0 0
Ballinasloe
Country [294] 0 0
Ireland
State/province [294] 0 0
Dublin
Country [295] 0 0
Ireland
State/province [295] 0 0
Galway
Country [296] 0 0
Israel
State/province [296] 0 0
Hadera
Country [297] 0 0
Israel
State/province [297] 0 0
Haifa
Country [298] 0 0
Israel
State/province [298] 0 0
Herzliya-on-sea
Country [299] 0 0
Israel
State/province [299] 0 0
Holon
Country [300] 0 0
Israel
State/province [300] 0 0
Jerusalem
Country [301] 0 0
Israel
State/province [301] 0 0
Nahariya
Country [302] 0 0
Israel
State/province [302] 0 0
Netanya
Country [303] 0 0
Israel
State/province [303] 0 0
Rehovot
Country [304] 0 0
Israel
State/province [304] 0 0
Tel Aviv
Country [305] 0 0
Israel
State/province [305] 0 0
Tel Hashomer
Country [306] 0 0
Italy
State/province [306] 0 0
Ascoli Piceno
Country [307] 0 0
Italy
State/province [307] 0 0
Bergamo
Country [308] 0 0
Italy
State/province [308] 0 0
Bologna
Country [309] 0 0
Italy
State/province [309] 0 0
Chieti
Country [310] 0 0
Italy
State/province [310] 0 0
Colleferro RM
Country [311] 0 0
Italy
State/province [311] 0 0
Cortona AR
Country [312] 0 0
Italy
State/province [312] 0 0
Firenze
Country [313] 0 0
Italy
State/province [313] 0 0
L' Aquila
Country [314] 0 0
Italy
State/province [314] 0 0
Milano
Country [315] 0 0
Italy
State/province [315] 0 0
Napoli
Country [316] 0 0
Italy
State/province [316] 0 0
Palermo
Country [317] 0 0
Italy
State/province [317] 0 0
Parma
Country [318] 0 0
Italy
State/province [318] 0 0
Pavia
Country [319] 0 0
Italy
State/province [319] 0 0
Perugia
Country [320] 0 0
Italy
State/province [320] 0 0
Pisa
Country [321] 0 0
Italy
State/province [321] 0 0
Roma
Country [322] 0 0
Italy
State/province [322] 0 0
Sanremo (IM)
Country [323] 0 0
Italy
State/province [323] 0 0
Siena
Country [324] 0 0
Japan
State/province [324] 0 0
Aichi
Country [325] 0 0
Japan
State/province [325] 0 0
Chiba
Country [326] 0 0
Japan
State/province [326] 0 0
Ehime
Country [327] 0 0
Japan
State/province [327] 0 0
Fukuoka
Country [328] 0 0
Japan
State/province [328] 0 0
Fukushima
Country [329] 0 0
Japan
State/province [329] 0 0
Hiroshima
Country [330] 0 0
Japan
State/province [330] 0 0
Hokkaido
Country [331] 0 0
Japan
State/province [331] 0 0
Hyogo
Country [332] 0 0
Japan
State/province [332] 0 0
Ibaraki
Country [333] 0 0
Japan
State/province [333] 0 0
Ishikawa
Country [334] 0 0
Japan
State/province [334] 0 0
Kagawa
Country [335] 0 0
Japan
State/province [335] 0 0
Kanagawa
Country [336] 0 0
Japan
State/province [336] 0 0
Kumamoto
Country [337] 0 0
Japan
State/province [337] 0 0
Kyoto
Country [338] 0 0
Japan
State/province [338] 0 0
Miyagi
Country [339] 0 0
Japan
State/province [339] 0 0
Nagasaki
Country [340] 0 0
Japan
State/province [340] 0 0
Oita
Country [341] 0 0
Japan
State/province [341] 0 0
Okayama
Country [342] 0 0
Japan
State/province [342] 0 0
Okinawa
Country [343] 0 0
Japan
State/province [343] 0 0
Osaka
Country [344] 0 0
Japan
State/province [344] 0 0
Saga
Country [345] 0 0
Japan
State/province [345] 0 0
Saitama
Country [346] 0 0
Japan
State/province [346] 0 0
Shiga
Country [347] 0 0
Japan
State/province [347] 0 0
Shimane
Country [348] 0 0
Japan
State/province [348] 0 0
Shizuoka
Country [349] 0 0
Japan
State/province [349] 0 0
Tokushima
Country [350] 0 0
Japan
State/province [350] 0 0
Tokyo
Country [351] 0 0
Japan
State/province [351] 0 0
Yamanashi
Country [352] 0 0
Korea, Republic of
State/province [352] 0 0
Busan, Seo-gu
Country [353] 0 0
Korea, Republic of
State/province [353] 0 0
Daejeon
Country [354] 0 0
Korea, Republic of
State/province [354] 0 0
Goyang-si, Gyeonggi-do
Country [355] 0 0
Korea, Republic of
State/province [355] 0 0
Gwangju
Country [356] 0 0
Korea, Republic of
State/province [356] 0 0
Seongnam-si
Country [357] 0 0
Korea, Republic of
State/province [357] 0 0
Seoul
Country [358] 0 0
Korea, Republic of
State/province [358] 0 0
Suwon-si
Country [359] 0 0
Latvia
State/province [359] 0 0
Daugavpils
Country [360] 0 0
Latvia
State/province [360] 0 0
Kuldiga
Country [361] 0 0
Latvia
State/province [361] 0 0
Liepaja
Country [362] 0 0
Latvia
State/province [362] 0 0
Ogre
Country [363] 0 0
Latvia
State/province [363] 0 0
Riga
Country [364] 0 0
Lithuania
State/province [364] 0 0
Kaunas
Country [365] 0 0
Lithuania
State/province [365] 0 0
Klaipeda
Country [366] 0 0
Lithuania
State/province [366] 0 0
Vilnius
Country [367] 0 0
Malaysia
State/province [367] 0 0
Johor
Country [368] 0 0
Malaysia
State/province [368] 0 0
Perak
Country [369] 0 0
Malaysia
State/province [369] 0 0
Sabah
Country [370] 0 0
Malaysia
State/province [370] 0 0
Wilayah Persekutuan
Country [371] 0 0
Malaysia
State/province [371] 0 0
Georgetown
Country [372] 0 0
Malaysia
State/province [372] 0 0
Kuala Lumpur
Country [373] 0 0
Malaysia
State/province [373] 0 0
Melaka
Country [374] 0 0
Malaysia
State/province [374] 0 0
Penang
Country [375] 0 0
Mexico
State/province [375] 0 0
Coahuila
Country [376] 0 0
Mexico
State/province [376] 0 0
Distrito Federal
Country [377] 0 0
Mexico
State/province [377] 0 0
Guanajuato
Country [378] 0 0
Mexico
State/province [378] 0 0
Jalisco
Country [379] 0 0
Mexico
State/province [379] 0 0
Nuevo León
Country [380] 0 0
Mexico
State/province [380] 0 0
Querétaro
Country [381] 0 0
Mexico
State/province [381] 0 0
San Luis Potosí
Country [382] 0 0
Mexico
State/province [382] 0 0
Sinaloa
Country [383] 0 0
Mexico
State/province [383] 0 0
Tamaulipas
Country [384] 0 0
Mexico
State/province [384] 0 0
Veracruz
Country [385] 0 0
Mexico
State/province [385] 0 0
Aguascalientes
Country [386] 0 0
Mexico
State/province [386] 0 0
Chihuahua
Country [387] 0 0
Netherlands
State/province [387] 0 0
Alkmaar
Country [388] 0 0
Netherlands
State/province [388] 0 0
Almelo
Country [389] 0 0
Netherlands
State/province [389] 0 0
Amstelveen
Country [390] 0 0
Netherlands
State/province [390] 0 0
Amsterdam
Country [391] 0 0
Netherlands
State/province [391] 0 0
Arnhem
Country [392] 0 0
Netherlands
State/province [392] 0 0
Beverwijk
Country [393] 0 0
Netherlands
State/province [393] 0 0
Den Helder
Country [394] 0 0
Netherlands
State/province [394] 0 0
Deventer
Country [395] 0 0
Netherlands
State/province [395] 0 0
Doetinchem
Country [396] 0 0
Netherlands
State/province [396] 0 0
Ede
Country [397] 0 0
Netherlands
State/province [397] 0 0
Eindhoven
Country [398] 0 0
Netherlands
State/province [398] 0 0
Goes
Country [399] 0 0
Netherlands
State/province [399] 0 0
Gorinchem
Country [400] 0 0
Netherlands
State/province [400] 0 0
Gouda
Country [401] 0 0
Netherlands
State/province [401] 0 0
Harderwijk
Country [402] 0 0
Netherlands
State/province [402] 0 0
Helmond
Country [403] 0 0
Netherlands
State/province [403] 0 0
Hoogeveen
Country [404] 0 0
Netherlands
State/province [404] 0 0
Hoorn
Country [405] 0 0
Netherlands
State/province [405] 0 0
Leiden
Country [406] 0 0
Netherlands
State/province [406] 0 0
Nieuwegein
Country [407] 0 0
Netherlands
State/province [407] 0 0
Nijmegen
Country [408] 0 0
Netherlands
State/province [408] 0 0
Purmerend
Country [409] 0 0
Netherlands
State/province [409] 0 0
Rotterdam
Country [410] 0 0
Netherlands
State/province [410] 0 0
Sneek
Country [411] 0 0
Netherlands
State/province [411] 0 0
Tiel
Country [412] 0 0
Netherlands
State/province [412] 0 0
Tilburg
Country [413] 0 0
Netherlands
State/province [413] 0 0
Uden
Country [414] 0 0
Netherlands
State/province [414] 0 0
Veldhoven
Country [415] 0 0
Netherlands
State/province [415] 0 0
Venlo
Country [416] 0 0
New Zealand
State/province [416] 0 0
Christchurch
Country [417] 0 0
New Zealand
State/province [417] 0 0
Papatoetoe, Auckland
Country [418] 0 0
New Zealand
State/province [418] 0 0
Tauranga
Country [419] 0 0
Norway
State/province [419] 0 0
Bekkestua
Country [420] 0 0
Norway
State/province [420] 0 0
Bodø
Country [421] 0 0
Norway
State/province [421] 0 0
Hamar
Country [422] 0 0
Norway
State/province [422] 0 0
Lierskogen
Country [423] 0 0
Norway
State/province [423] 0 0
Oslo
Country [424] 0 0
Norway
State/province [424] 0 0
Skedsmokorset
Country [425] 0 0
Norway
State/province [425] 0 0
Skien
Country [426] 0 0
Norway
State/province [426] 0 0
Stavanger
Country [427] 0 0
Norway
State/province [427] 0 0
Ålesund
Country [428] 0 0
Philippines
State/province [428] 0 0
Davao
Country [429] 0 0
Philippines
State/province [429] 0 0
Angeles
Country [430] 0 0
Philippines
State/province [430] 0 0
Baguio City
Country [431] 0 0
Philippines
State/province [431] 0 0
Dasmariñas Cavite
Country [432] 0 0
Philippines
State/province [432] 0 0
Iloilo
Country [433] 0 0
Philippines
State/province [433] 0 0
Makati City
Country [434] 0 0
Philippines
State/province [434] 0 0
Manila
Country [435] 0 0
Philippines
State/province [435] 0 0
Marikiina
Country [436] 0 0
Philippines
State/province [436] 0 0
Quezon City
Country [437] 0 0
Poland
State/province [437] 0 0
Bielsko-Biala
Country [438] 0 0
Poland
State/province [438] 0 0
Bydgoszcz
Country [439] 0 0
Poland
State/province [439] 0 0
Gdansk
Country [440] 0 0
Poland
State/province [440] 0 0
Gdynia
Country [441] 0 0
Poland
State/province [441] 0 0
Gizycko
Country [442] 0 0
Poland
State/province [442] 0 0
Jelenia Gora
Country [443] 0 0
Poland
State/province [443] 0 0
Katowice
Country [444] 0 0
Poland
State/province [444] 0 0
Kielce
Country [445] 0 0
Poland
State/province [445] 0 0
Krakow
Country [446] 0 0
Poland
State/province [446] 0 0
Lodz
Country [447] 0 0
Poland
State/province [447] 0 0
Lublin
Country [448] 0 0
Poland
State/province [448] 0 0
Nowa Sol
Country [449] 0 0
Poland
State/province [449] 0 0
Nysa
Country [450] 0 0
Poland
State/province [450] 0 0
Olsztyn
Country [451] 0 0
Poland
State/province [451] 0 0
Plock
Country [452] 0 0
Poland
State/province [452] 0 0
Poznan
Country [453] 0 0
Poland
State/province [453] 0 0
Pszczyna
Country [454] 0 0
Poland
State/province [454] 0 0
Pulawy
Country [455] 0 0
Poland
State/province [455] 0 0
Ruda Slaska
Country [456] 0 0
Poland
State/province [456] 0 0
Skierniewice
Country [457] 0 0
Poland
State/province [457] 0 0
Starogard Gdanski
Country [458] 0 0
Poland
State/province [458] 0 0
Staszow
Country [459] 0 0
Poland
State/province [459] 0 0
Swidnik
Country [460] 0 0
Poland
State/province [460] 0 0
Tarnow
Country [461] 0 0
Poland
State/province [461] 0 0
Torun
Country [462] 0 0
Poland
State/province [462] 0 0
Warszawa
Country [463] 0 0
Poland
State/province [463] 0 0
Wloclawek
Country [464] 0 0
Poland
State/province [464] 0 0
Wroclaw
Country [465] 0 0
Poland
State/province [465] 0 0
Zamosc
Country [466] 0 0
Portugal
State/province [466] 0 0
Almada
Country [467] 0 0
Portugal
State/province [467] 0 0
Amadora
Country [468] 0 0
Portugal
State/province [468] 0 0
Carnaxide
Country [469] 0 0
Portugal
State/province [469] 0 0
Coimbra
Country [470] 0 0
Portugal
State/province [470] 0 0
Covilha
Country [471] 0 0
Portugal
State/province [471] 0 0
Lisboa
Country [472] 0 0
Portugal
State/province [472] 0 0
Porto
Country [473] 0 0
Portugal
State/province [473] 0 0
Setubal
Country [474] 0 0
Romania
State/province [474] 0 0
Bucharest
Country [475] 0 0
Romania
State/province [475] 0 0
Bucuresti
Country [476] 0 0
Romania
State/province [476] 0 0
Cluj-Napoca
Country [477] 0 0
Romania
State/province [477] 0 0
Craiova
Country [478] 0 0
Romania
State/province [478] 0 0
Iasi
Country [479] 0 0
Romania
State/province [479] 0 0
Oradea
Country [480] 0 0
Romania
State/province [480] 0 0
Timisoara
Country [481] 0 0
Russian Federation
State/province [481] 0 0
Barnaul
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Russian Federation
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York

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

No information has been provided regarding IPD availability


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.