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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01663402




Registration number
NCT01663402
Ethics application status
Date submitted
8/08/2012
Date registered
13/08/2012
Date last updated
18/03/2019

Titles & IDs
Public title
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Secondary ID [1] 0 0
2011-005698-21
Secondary ID [2] 0 0
EFC11570
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
Coronary heart disease
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
Treatment: Drugs - Alirocumab
Treatment: Drugs - Placebo
Treatment: Drugs - LMT

Placebo comparator: Placebo - Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.

Experimental: Alirocumab 75 mg Q2W/Up to 150 mg Q2W - Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).


Treatment: Drugs: Alirocumab
Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

Treatment: Drugs: Placebo
Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

Treatment: Drugs: LMT
Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.

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

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [1] 0 0
From randomization up to 64 months
Secondary outcome [1] 0 0
Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [1] 0 0
From randomization up to 64 months
Secondary outcome [2] 0 0
Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [2] 0 0
From randomization up to 64 months
Secondary outcome [3] 0 0
Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [3] 0 0
From randomization up to 64 months
Secondary outcome [4] 0 0
Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [4] 0 0
From randomization up to 64 months
Secondary outcome [5] 0 0
Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [5] 0 0
From randomization up to 64 months
Secondary outcome [6] 0 0
Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [6] 0 0
From randomization up to 64 months
Secondary outcome [7] 0 0
Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [7] 0 0
From randomization up to 64 months
Secondary outcome [8] 0 0
Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [8] 0 0
From randomization up to 64 months
Secondary outcome [9] 0 0
Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [9] 0 0
From randomization up to 64 months
Secondary outcome [10] 0 0
Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [10] 0 0
From randomization up to 64 months
Secondary outcome [11] 0 0
Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [11] 0 0
From randomization up to 64 months
Secondary outcome [12] 0 0
Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [12] 0 0
From randomization up to 64 months

Eligibility
Key inclusion criteria
Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Age < 40 years.
* ACS event occurring more than 52 weeks prior to randomization visit.
* LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL (<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study design
Purpose of the study
Prevention
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 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)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Ashford
Recruitment hospital [2] 0 0
Investigational Site Number 036023 - Auchenflower
Recruitment hospital [3] 0 0
Investigational Site Number 036024 - Ballarat
Recruitment hospital [4] 0 0
Investigational Site Number 036020 - Bedford Park
Recruitment hospital [5] 0 0
Investigational Site Number 036015 - Bruce
Recruitment hospital [6] 0 0
Investigational Site Number 036026 - Cairns
Recruitment hospital [7] 0 0
Investigational Site Number 036005 - Chermside
Recruitment hospital [8] 0 0
Investigational Site Number 036008 - Chermside
Recruitment hospital [9] 0 0
Investigational Site Number 036011 - Coffs Harbour
Recruitment hospital [10] 0 0
Investigational Site Number 036003 - Concord
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Investigational Site Number 036017 - Elizabeth Vale
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Investigational Site Number 036006 - Fullarton
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Investigational Site Number 036004 - Gosford
Recruitment hospital [14] 0 0
Investigational Site Number 036019 - Heidelberg West
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Investigational Site Number 036027 - Hobart
Recruitment hospital [16] 0 0
Investigational Site Number 036009 - Kogarah
Recruitment hospital [17] 0 0
Investigational Site Number 036012 - Mildura
Recruitment hospital [18] 0 0
Investigational Site Number 036028 - Nambour
Recruitment hospital [19] 0 0
Investigational Site Number 036013 - New Lambton
Recruitment hospital [20] 0 0
Investigational Site Number 036010 - Perth
Recruitment hospital [21] 0 0
Investigational Site Number 036014 - Prahran
Recruitment hospital [22] 0 0
Investigational Site Number 036018 - Redcliffe
Recruitment hospital [23] 0 0
Investigational Site Number 036022 - Richmond
Recruitment hospital [24] 0 0
Investigational Site Number 036025 - Woodville South
Recruitment hospital [25] 0 0
Investigational Site Number 036021 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5035 - Ashford
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3353 - Ballarat
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
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2617 - Bruce
Recruitment postcode(s) [6] 0 0
4870 - Cairns
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4032 - Chermside
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2450 - Coffs Harbour
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2137 - Concord
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
5063 - Fullarton
Recruitment postcode(s) [12] 0 0
2250 - Gosford
Recruitment postcode(s) [13] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [14] 0 0
7001 - Hobart
Recruitment postcode(s) [15] 0 0
2217 - Kogarah
Recruitment postcode(s) [16] 0 0
3500 - Mildura
Recruitment postcode(s) [17] 0 0
4560 - Nambour
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2305 - New Lambton
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6000 - Perth
Recruitment postcode(s) [20] 0 0
3004 - Prahran
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4020 - Redcliffe
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3121 - Richmond
Recruitment postcode(s) [23] 0 0
5011 - Woodville South
Recruitment postcode(s) [24] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Country [176] 0 0
Chile
State/province [176] 0 0
Temuco
Country [177] 0 0
Chile
State/province [177] 0 0
Valdivia
Country [178] 0 0
Chile
State/province [178] 0 0
Viña Del Mar
Country [179] 0 0
China
State/province [179] 0 0
Baotou
Country [180] 0 0
China
State/province [180] 0 0
Beijing
Country [181] 0 0
China
State/province [181] 0 0
Changchun
Country [182] 0 0
China
State/province [182] 0 0
Changsha
Country [183] 0 0
China
State/province [183] 0 0
Chongqing
Country [184] 0 0
China
State/province [184] 0 0
Fuzhou
Country [185] 0 0
China
State/province [185] 0 0
Guangzhou
Country [186] 0 0
China
State/province [186] 0 0
Guiyang
Country [187] 0 0
China
State/province [187] 0 0
Hangzhou
Country [188] 0 0
China
State/province [188] 0 0
Hohhot
Country [189] 0 0
China
State/province [189] 0 0
Jinan
Country [190] 0 0
China
State/province [190] 0 0
Lanzhou
Country [191] 0 0
China
State/province [191] 0 0
Luzhou
Country [192] 0 0
China
State/province [192] 0 0
Nanchang
Country [193] 0 0
China
State/province [193] 0 0
Nanjing
Country [194] 0 0
China
State/province [194] 0 0
Shanghai
Country [195] 0 0
China
State/province [195] 0 0
Shenyang
Country [196] 0 0
China
State/province [196] 0 0
Shenzhen
Country [197] 0 0
China
State/province [197] 0 0
Siping
Country [198] 0 0
China
State/province [198] 0 0
Suzhou
Country [199] 0 0
China
State/province [199] 0 0
Tianjin
Country [200] 0 0
China
State/province [200] 0 0
Wenzhou
Country [201] 0 0
China
State/province [201] 0 0
Wuhan
Country [202] 0 0
China
State/province [202] 0 0
Xi'An
Country [203] 0 0
China
State/province [203] 0 0
Xuzhou
Country [204] 0 0
China
State/province [204] 0 0
Yanji
Country [205] 0 0
China
State/province [205] 0 0
Yueyang
Country [206] 0 0
China
State/province [206] 0 0
Zhanjiang
Country [207] 0 0
Colombia
State/province [207] 0 0
Armenia
Country [208] 0 0
Colombia
State/province [208] 0 0
Barranquilla
Country [209] 0 0
Colombia
State/province [209] 0 0
Bogota D.C.
Country [210] 0 0
Colombia
State/province [210] 0 0
Bogota
Country [211] 0 0
Colombia
State/province [211] 0 0
Cali
Country [212] 0 0
Colombia
State/province [212] 0 0
Cartagena
Country [213] 0 0
Colombia
State/province [213] 0 0
Espinal - Tolima
Country [214] 0 0
Colombia
State/province [214] 0 0
Floridablanca
Country [215] 0 0
Colombia
State/province [215] 0 0
Manizales
Country [216] 0 0
Colombia
State/province [216] 0 0
Medellin
Country [217] 0 0
Croatia
State/province [217] 0 0
Dubrovnik
Country [218] 0 0
Croatia
State/province [218] 0 0
Krapinske Toplice
Country [219] 0 0
Croatia
State/province [219] 0 0
Opatija
Country [220] 0 0
Croatia
State/province [220] 0 0
Rijeka
Country [221] 0 0
Croatia
State/province [221] 0 0
Slavonski Brod
Country [222] 0 0
Croatia
State/province [222] 0 0
Varazdin
Country [223] 0 0
Croatia
State/province [223] 0 0
Zagreb
Country [224] 0 0
Czechia
State/province [224] 0 0
Brno
Country [225] 0 0
Czechia
State/province [225] 0 0
Ceska Lipa
Country [226] 0 0
Czechia
State/province [226] 0 0
Cesky Krumlov
Country [227] 0 0
Czechia
State/province [227] 0 0
Hodonin
Country [228] 0 0
Czechia
State/province [228] 0 0
Hradec Kralove
Country [229] 0 0
Czechia
State/province [229] 0 0
Kladno
Country [230] 0 0
Czechia
State/province [230] 0 0
Kromeriz
Country [231] 0 0
Czechia
State/province [231] 0 0
Liberec
Country [232] 0 0
Czechia
State/province [232] 0 0
Marianske Lazne
Country [233] 0 0
Czechia
State/province [233] 0 0
Olomouc
Country [234] 0 0
Czechia
State/province [234] 0 0
Ostrava
Country [235] 0 0
Czechia
State/province [235] 0 0
Pardubice
Country [236] 0 0
Czechia
State/province [236] 0 0
Plzen
Country [237] 0 0
Czechia
State/province [237] 0 0
Praha 10
Country [238] 0 0
Czechia
State/province [238] 0 0
Praha 2
Country [239] 0 0
Czechia
State/province [239] 0 0
Praha 4
Country [240] 0 0
Czechia
State/province [240] 0 0
Praha 5 - Motol
Country [241] 0 0
Czechia
State/province [241] 0 0
Praha 5
Country [242] 0 0
Czechia
State/province [242] 0 0
Rakovnik
Country [243] 0 0
Czechia
State/province [243] 0 0
Zlin
Country [244] 0 0
Denmark
State/province [244] 0 0
Aabenraa
Country [245] 0 0
Denmark
State/province [245] 0 0
Aalborg
Country [246] 0 0
Denmark
State/province [246] 0 0
Aarhus N
Country [247] 0 0
Denmark
State/province [247] 0 0
Copenhagen
Country [248] 0 0
Denmark
State/province [248] 0 0
Glostrup
Country [249] 0 0
Denmark
State/province [249] 0 0
Hellerup
Country [250] 0 0
Denmark
State/province [250] 0 0
Herning
Country [251] 0 0
Denmark
State/province [251] 0 0
Hillerød
Country [252] 0 0
Denmark
State/province [252] 0 0
Holbaek
Country [253] 0 0
Denmark
State/province [253] 0 0
Hvidovre
Country [254] 0 0
Denmark
State/province [254] 0 0
Køge
Country [255] 0 0
Denmark
State/province [255] 0 0
Næstved
Country [256] 0 0
Denmark
State/province [256] 0 0
Odense C
Country [257] 0 0
Denmark
State/province [257] 0 0
Silkeborg
Country [258] 0 0
Denmark
State/province [258] 0 0
Slagelse
Country [259] 0 0
Denmark
State/province [259] 0 0
Vejle
Country [260] 0 0
Denmark
State/province [260] 0 0
Viborg
Country [261] 0 0
Estonia
State/province [261] 0 0
Pärnu
Country [262] 0 0
Estonia
State/province [262] 0 0
Tallinn
Country [263] 0 0
Estonia
State/province [263] 0 0
Tartu
Country [264] 0 0
Estonia
State/province [264] 0 0
Viljandimaa
Country [265] 0 0
Finland
State/province [265] 0 0
Helsinki
Country [266] 0 0
Finland
State/province [266] 0 0
Oulu
Country [267] 0 0
Finland
State/province [267] 0 0
Tampere
Country [268] 0 0
Finland
State/province [268] 0 0
Turku
Country [269] 0 0
France
State/province [269] 0 0
Besancon
Country [270] 0 0
France
State/province [270] 0 0
Brest Cedex
Country [271] 0 0
France
State/province [271] 0 0
Cambrai Cedex
Country [272] 0 0
France
State/province [272] 0 0
Clermont-Ferrand Cedex 1
Country [273] 0 0
France
State/province [273] 0 0
Compiegne
Country [274] 0 0
France
State/province [274] 0 0
Dijon
Country [275] 0 0
France
State/province [275] 0 0
Grenoble
Country [276] 0 0
France
State/province [276] 0 0
Limoges Cedex 1
Country [277] 0 0
France
State/province [277] 0 0
Marseille
Country [278] 0 0
France
State/province [278] 0 0
Massy
Country [279] 0 0
France
State/province [279] 0 0
Montfermeil
Country [280] 0 0
France
State/province [280] 0 0
Montpellier Cedex 5
Country [281] 0 0
France
State/province [281] 0 0
Nantes
Country [282] 0 0
France
State/province [282] 0 0
Nice Cedex 01
Country [283] 0 0
France
State/province [283] 0 0
Paris Cedex 12
Country [284] 0 0
France
State/province [284] 0 0
Paris
Country [285] 0 0
France
State/province [285] 0 0
Pau
Country [286] 0 0
France
State/province [286] 0 0
Pessac
Country [287] 0 0
France
State/province [287] 0 0
Rouen
Country [288] 0 0
France
State/province [288] 0 0
Strasbourg Cedex
Country [289] 0 0
Georgia
State/province [289] 0 0
Batumi
Country [290] 0 0
Georgia
State/province [290] 0 0
Kutaisi
Country [291] 0 0
Georgia
State/province [291] 0 0
Tbilisi
Country [292] 0 0
Germany
State/province [292] 0 0
Aachen
Country [293] 0 0
Germany
State/province [293] 0 0
Bad Krozingen
Country [294] 0 0
Germany
State/province [294] 0 0
Berlin
Country [295] 0 0
Germany
State/province [295] 0 0
Bernau
Country [296] 0 0
Germany
State/province [296] 0 0
Bielefeld
Country [297] 0 0
Germany
State/province [297] 0 0
Bonn
Country [298] 0 0
Germany
State/province [298] 0 0
Dortmund
Country [299] 0 0
Germany
State/province [299] 0 0
Dresden
Country [300] 0 0
Germany
State/province [300] 0 0
Eschweiler
Country [301] 0 0
Germany
State/province [301] 0 0
Essen
Country [302] 0 0
Germany
State/province [302] 0 0
Frankfurt Am Main
Country [303] 0 0
Germany
State/province [303] 0 0
Freiburg
Country [304] 0 0
Germany
State/province [304] 0 0
Halle/Saale
Country [305] 0 0
Germany
State/province [305] 0 0
Hamburg
Country [306] 0 0
Germany
State/province [306] 0 0
Hamm
Country [307] 0 0
Germany
State/province [307] 0 0
Haßloch
Country [308] 0 0
Germany
State/province [308] 0 0
Heidelberg
Country [309] 0 0
Germany
State/province [309] 0 0
Homburg/Saar
Country [310] 0 0
Germany
State/province [310] 0 0
Kassel
Country [311] 0 0
Germany
State/province [311] 0 0
Leipzig
Country [312] 0 0
Germany
State/province [312] 0 0
Limburg
Country [313] 0 0
Germany
State/province [313] 0 0
Lippstadt
Country [314] 0 0
Germany
State/province [314] 0 0
Lübeck
Country [315] 0 0
Germany
State/province [315] 0 0
Magdeburg
Country [316] 0 0
Germany
State/province [316] 0 0
Mainz
Country [317] 0 0
Germany
State/province [317] 0 0
Marburg
Country [318] 0 0
Germany
State/province [318] 0 0
Münster
Country [319] 0 0
Germany
State/province [319] 0 0
Nürnberg
Country [320] 0 0
Germany
State/province [320] 0 0
Peine
Country [321] 0 0
Germany
State/province [321] 0 0
Rotenburg An Der Fulda
Country [322] 0 0
Germany
State/province [322] 0 0
Rüdersdorf Bei Berlin
Country [323] 0 0
Germany
State/province [323] 0 0
Stuttgart
Country [324] 0 0
Germany
State/province [324] 0 0
Warendorf
Country [325] 0 0
Greece
State/province [325] 0 0
Athens
Country [326] 0 0
Greece
State/province [326] 0 0
Chios
Country [327] 0 0
Greece
State/province [327] 0 0
Haidari
Country [328] 0 0
Greece
State/province [328] 0 0
Heraklion
Country [329] 0 0
Greece
State/province [329] 0 0
Ioannina
Country [330] 0 0
Greece
State/province [330] 0 0
Marousi
Country [331] 0 0
Greece
State/province [331] 0 0
N. Ionia
Country [332] 0 0
Greece
State/province [332] 0 0
Patra
Country [333] 0 0
Greece
State/province [333] 0 0
Thessaloniki
Country [334] 0 0
Guatemala
State/province [334] 0 0
Guatemala
Country [335] 0 0
Hong Kong
State/province [335] 0 0
Hong Kong
Country [336] 0 0
Hong Kong
State/province [336] 0 0
Shatin, Nt
Country [337] 0 0
Hungary
State/province [337] 0 0
Balatonfüred
Country [338] 0 0
Hungary
State/province [338] 0 0
Budapest
Country [339] 0 0
Hungary
State/province [339] 0 0
Debrecen
Country [340] 0 0
Hungary
State/province [340] 0 0
Eger
Country [341] 0 0
Hungary
State/province [341] 0 0
Gyula
Country [342] 0 0
Hungary
State/province [342] 0 0
Pécs
Country [343] 0 0
Hungary
State/province [343] 0 0
Szeged
Country [344] 0 0
Hungary
State/province [344] 0 0
Szekesfehervar
Country [345] 0 0
Hungary
State/province [345] 0 0
Szombathely
Country [346] 0 0
Hungary
State/province [346] 0 0
Zalaegerszeg
Country [347] 0 0
India
State/province [347] 0 0
Ahmedabad
Country [348] 0 0
India
State/province [348] 0 0
Aurangabad
Country [349] 0 0
India
State/province [349] 0 0
Bangalore
Country [350] 0 0
India
State/province [350] 0 0
Belgaum
Country [351] 0 0
India
State/province [351] 0 0
Bikaner
Country [352] 0 0
India
State/province [352] 0 0
Chennai
Country [353] 0 0
India
State/province [353] 0 0
Delhi
Country [354] 0 0
India
State/province [354] 0 0
Gurgaon
Country [355] 0 0
India
State/province [355] 0 0
Hyderabad
Country [356] 0 0
India
State/province [356] 0 0
Jaipur
Country [357] 0 0
India
State/province [357] 0 0
Karad
Country [358] 0 0
India
State/province [358] 0 0
Karamsad
Country [359] 0 0
India
State/province [359] 0 0
Kochi
Country [360] 0 0
India
State/province [360] 0 0
Kolhapur
Country [361] 0 0
India
State/province [361] 0 0
Kolkata
Country [362] 0 0
India
State/province [362] 0 0
Ludhiana
Country [363] 0 0
India
State/province [363] 0 0
Mangalore
Country [364] 0 0
India
State/province [364] 0 0
Mumbai
Country [365] 0 0
India
State/province [365] 0 0
Mysore
Country [366] 0 0
India
State/province [366] 0 0
Nagpur
Country [367] 0 0
India
State/province [367] 0 0
Nashik
Country [368] 0 0
India
State/province [368] 0 0
New Delhi
Country [369] 0 0
India
State/province [369] 0 0
Panaji
Country [370] 0 0
India
State/province [370] 0 0
Pune
Country [371] 0 0
India
State/province [371] 0 0
Secunderabad, Hyderabad
Country [372] 0 0
India
State/province [372] 0 0
Secunderabad
Country [373] 0 0
India
State/province [373] 0 0
Surat
Country [374] 0 0
India
State/province [374] 0 0
Vijayawada
Country [375] 0 0
India
State/province [375] 0 0
Vijaywada
Country [376] 0 0
India
State/province [376] 0 0
Visakhapatnam
Country [377] 0 0
India
State/province [377] 0 0
Vishkhapattanam
Country [378] 0 0
India
State/province [378] 0 0
Wardha
Country [379] 0 0
Israel
State/province [379] 0 0
Afula
Country [380] 0 0
Israel
State/province [380] 0 0
Ashkelon
Country [381] 0 0
Israel
State/province [381] 0 0
Beer Sheva
Country [382] 0 0
Israel
State/province [382] 0 0
Haifa
Country [383] 0 0
Israel
State/province [383] 0 0
Holon
Country [384] 0 0
Israel
State/province [384] 0 0
Jerusalem
Country [385] 0 0
Israel
State/province [385] 0 0
Kfar Saba
Country [386] 0 0
Israel
State/province [386] 0 0
Nahariya
Country [387] 0 0
Israel
State/province [387] 0 0
Nazareth
Country [388] 0 0
Israel
State/province [388] 0 0
Petah-Tikva
Country [389] 0 0
Israel
State/province [389] 0 0
Rehovot
Country [390] 0 0
Israel
State/province [390] 0 0
Safed
Country [391] 0 0
Israel
State/province [391] 0 0
Tel Aviv
Country [392] 0 0
Israel
State/province [392] 0 0
Tel Hashomer
Country [393] 0 0
Israel
State/province [393] 0 0
Tiberias
Country [394] 0 0
Israel
State/province [394] 0 0
Tzrifin
Country [395] 0 0
Italy
State/province [395] 0 0
Augusta
Country [396] 0 0
Italy
State/province [396] 0 0
Bergamo
Country [397] 0 0
Italy
State/province [397] 0 0
Brescia
Country [398] 0 0
Italy
State/province [398] 0 0
Ferrara
Country [399] 0 0
Italy
State/province [399] 0 0
Forlì
Country [400] 0 0
Italy
State/province [400] 0 0
Livorno
Country [401] 0 0
Italy
State/province [401] 0 0
Massa
Country [402] 0 0
Italy
State/province [402] 0 0
Milano
Country [403] 0 0
Italy
State/province [403] 0 0
Monza
Country [404] 0 0
Italy
State/province [404] 0 0
Napoli
Country [405] 0 0
Italy
State/province [405] 0 0
Novara
Country [406] 0 0
Italy
State/province [406] 0 0
Osio Sotto
Country [407] 0 0
Italy
State/province [407] 0 0
Palermo
Country [408] 0 0
Italy
State/province [408] 0 0
Perugia
Country [409] 0 0
Italy
State/province [409] 0 0
Rho
Country [410] 0 0
Italy
State/province [410] 0 0
Rimini
Country [411] 0 0
Italy
State/province [411] 0 0
Roma
Country [412] 0 0
Italy
State/province [412] 0 0
Seriate
Country [413] 0 0
Italy
State/province [413] 0 0
Treviso
Country [414] 0 0
Italy
State/province [414] 0 0
Vittorio Veneto
Country [415] 0 0
Japan
State/province [415] 0 0
Amagasaki-Shi
Country [416] 0 0
Japan
State/province [416] 0 0
Fukuoka-Shi
Country [417] 0 0
Japan
State/province [417] 0 0
Hachioji-Shi
Country [418] 0 0
Japan
State/province [418] 0 0
Higashihiroshima-Shi
Country [419] 0 0
Japan
State/province [419] 0 0
Higashiibaraki-Gun
Country [420] 0 0
Japan
State/province [420] 0 0
Hiroshima-Shi
Country [421] 0 0
Japan
State/province [421] 0 0
Itabashi-Ku
Country [422] 0 0
Japan
State/province [422] 0 0
Izumisano-Shi
Country [423] 0 0
Japan
State/province [423] 0 0
Kanazawa-Shi
Country [424] 0 0
Japan
State/province [424] 0 0
Kitakyushu-Shi
Country [425] 0 0
Japan
State/province [425] 0 0
Kobe-Shi
Country [426] 0 0
Japan
State/province [426] 0 0
Koga-Shi
Country [427] 0 0
Japan
State/province [427] 0 0
Komatsu-Shi
Country [428] 0 0
Japan
State/province [428] 0 0
Komatsushima-Shi
Country [429] 0 0
Japan
State/province [429] 0 0
Kumamoto-Shi
Country [430] 0 0
Japan
State/province [430] 0 0
Kure-Shi
Country [431] 0 0
Japan
State/province [431] 0 0
Kurume-Shi
Country [432] 0 0
Japan
State/province [432] 0 0
Kusatsu-Shi
Country [433] 0 0
Japan
State/province [433] 0 0
Kyoto City
Country [434] 0 0
Japan
State/province [434] 0 0
Minato-Ku
Country [435] 0 0
Japan
State/province [435] 0 0
Morioka-Shi
Country [436] 0 0
Japan
State/province [436] 0 0
Nagoya-Shi
Country [437] 0 0
Japan
State/province [437] 0 0
Nerima-Ku
Country [438] 0 0
Japan
State/province [438] 0 0
Osaka-Shi
Country [439] 0 0
Japan
State/province [439] 0 0
Sagamihara-Shi
Country [440] 0 0
Japan
State/province [440] 0 0
Sapporo-Shi
Country [441] 0 0
Japan
State/province [441] 0 0
Shinagawa-Ku
Country [442] 0 0
Japan
State/province [442] 0 0
Suita-Shi
Country [443] 0 0
Japan
State/province [443] 0 0
Tokushima-Shi
Country [444] 0 0
Japan
State/province [444] 0 0
Urasoe-Shi
Country [445] 0 0
Japan
State/province [445] 0 0
Yokohama-Shi
Country [446] 0 0
Korea, Republic of
State/province [446] 0 0
Busan
Country [447] 0 0
Korea, Republic of
State/province [447] 0 0
Daegu
Country [448] 0 0
Korea, Republic of
State/province [448] 0 0
Goyang-Si
Country [449] 0 0
Korea, Republic of
State/province [449] 0 0
Gwangju
Country [450] 0 0
Korea, Republic of
State/province [450] 0 0
Seongnam
Country [451] 0 0
Korea, Republic of
State/province [451] 0 0
Seoul
Country [452] 0 0
Korea, Republic of
State/province [452] 0 0
Suwon
Country [453] 0 0
Korea, Republic of
State/province [453] 0 0
Wonju
Country [454] 0 0
Latvia
State/province [454] 0 0
Daugavpils
Country [455] 0 0
Latvia
State/province [455] 0 0
Liepaja
Country [456] 0 0
Latvia
State/province [456] 0 0
Riga
Country [457] 0 0
Latvia
State/province [457] 0 0
Ventspils
Country [458] 0 0
Lithuania
State/province [458] 0 0
Kaunas
Country [459] 0 0
Lithuania
State/province [459] 0 0
Klaipeda
Country [460] 0 0
Lithuania
State/province [460] 0 0
Vilnius
Country [461] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [461] 0 0
Bitola
Country [462] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [462] 0 0
Shtip
Country [463] 0 0
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State/province [746] 0 0
Mykolaiv
Country [747] 0 0
Ukraine
State/province [747] 0 0
Odesa
Country [748] 0 0
Ukraine
State/province [748] 0 0
Odessa
Country [749] 0 0
Ukraine
State/province [749] 0 0
Simferopol
Country [750] 0 0
Ukraine
State/province [750] 0 0
Sumy
Country [751] 0 0
Ukraine
State/province [751] 0 0
Uzhgorod
Country [752] 0 0
Ukraine
State/province [752] 0 0
Vinnitsya
Country [753] 0 0
Ukraine
State/province [753] 0 0
Vinnytsia
Country [754] 0 0
Ukraine
State/province [754] 0 0
Zaporizhia
Country [755] 0 0
Ukraine
State/province [755] 0 0
Zhytomyr
Country [756] 0 0
United Kingdom
State/province [756] 0 0
Basildon
Country [757] 0 0
United Kingdom
State/province [757] 0 0
Birmingham
Country [758] 0 0
United Kingdom
State/province [758] 0 0
Bournemouth
Country [759] 0 0
United Kingdom
State/province [759] 0 0
Bradford
Country [760] 0 0
United Kingdom
State/province [760] 0 0
Burton On Trent
Country [761] 0 0
United Kingdom
State/province [761] 0 0
Cardiff
Country [762] 0 0
United Kingdom
State/province [762] 0 0
Chertsey
Country [763] 0 0
United Kingdom
State/province [763] 0 0
Chesterfield
Country [764] 0 0
United Kingdom
State/province [764] 0 0
Chichester
Country [765] 0 0
United Kingdom
State/province [765] 0 0
Cumbria
Country [766] 0 0
United Kingdom
State/province [766] 0 0
Dudley
Country [767] 0 0
United Kingdom
State/province [767] 0 0
Harrow
Country [768] 0 0
United Kingdom
State/province [768] 0 0
High Wycombe
Country [769] 0 0
United Kingdom
State/province [769] 0 0
Hull
Country [770] 0 0
United Kingdom
State/province [770] 0 0
London
Country [771] 0 0
United Kingdom
State/province [771] 0 0
Manchester
Country [772] 0 0
United Kingdom
State/province [772] 0 0
Newcastle Upon Tyne
Country [773] 0 0
United Kingdom
State/province [773] 0 0
Northampton
Country [774] 0 0
United Kingdom
State/province [774] 0 0
Peterborough
Country [775] 0 0
United Kingdom
State/province [775] 0 0
Plymouth
Country [776] 0 0
United Kingdom
State/province [776] 0 0
Portadown
Country [777] 0 0
United Kingdom
State/province [777] 0 0
Portsmouth
Country [778] 0 0
United Kingdom
State/province [778] 0 0
Redhill
Country [779] 0 0
United Kingdom
State/province [779] 0 0
Rhyl
Country [780] 0 0
United Kingdom
State/province [780] 0 0
Romford
Country [781] 0 0
United Kingdom
State/province [781] 0 0
Rotherham
Country [782] 0 0
United Kingdom
State/province [782] 0 0
Sheffield
Country [783] 0 0
United Kingdom
State/province [783] 0 0
South Shields
Country [784] 0 0
United Kingdom
State/province [784] 0 0
St Leonards
Country [785] 0 0
United Kingdom
State/province [785] 0 0
Stoke-On-Trent
Country [786] 0 0
United Kingdom
State/province [786] 0 0
Sunderland
Country [787] 0 0
United Kingdom
State/province [787] 0 0
Truro
Country [788] 0 0
United Kingdom
State/province [788] 0 0
Wigan
Country [789] 0 0
United Kingdom
State/province [789] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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?

Results publications and other study-related documents

No documents have been uploaded by study researchers.