ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Atherosclerotic Cardiovascular Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663402
• Other study ID #: EFC11570
• Secondary ID: 2011-005698-21U1
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: January 23, 2018

Study information

• Verified date: March 2019
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.

Secondary Objectives:

• To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).

• To evaluate the safety and tolerability of alirocumab.

• To evaluate the effect of alirocumab on lipid parameters.

Description:

18924 number of participants aged >= 40 years old were randomized in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18924
• Est. completion date: January 23, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Alirocumab
Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.
• Placebo
Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.
• LMT
Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.

Locations

Country	Name	City	State
Argentina	Investigational Site Number 032012	Adrogue
Argentina	Investigational Site Number 032018	Bahia Blanca
Argentina	Investigational Site Number 032011	Caba
Argentina	Investigational Site Number 032020	Caba
Argentina	Investigational Site Number 032023	Caba
Argentina	Investigational Site Number 032041	Caba
Argentina	Investigational Site Number 032045	Caba
Argentina	Investigational Site Number 032048	Caba
Argentina	Investigational Site Number 032050	Caba
Argentina	Investigational Site Number 032010	Ciudad De Buenos Aires
Argentina	Investigational Site Number 032046	Ciudadela
Argentina	Investigational Site Number 032008	Cordoba
Argentina	Investigational Site Number 032019	Cordoba
Argentina	Investigational Site Number 032021	Cordoba
Argentina	Investigational Site Number 032031	Cordoba
Argentina	Investigational Site Number 032032	Cordoba
Argentina	Investigational Site Number 032038	Cordoba
Argentina	Investigational Site Number 032042	Cordoba
Argentina	Investigational Site Number 032026	Córdoba
Argentina	Investigational Site Number 032049	Córdoba
Argentina	Investigational Site Number 032017	Coronel Suarez
Argentina	Investigational Site Number 032009	Corrientes
Argentina	Investigational Site Number 032005	Junin
Argentina	Investigational Site Number 032001	La Plata
Argentina	Investigational Site Number 032040	La Plata
Argentina	Investigational Site Number 032014	Mar Del Plata
Argentina	Investigational Site Number 032033	Mar Del Plata
Argentina	Investigational Site Number 032016	Mendoza
Argentina	Investigational Site Number 032030	Merlo
Argentina	Investigational Site Number 032036	Moron
Argentina	Investigational Site Number 032007	Olivos
Argentina	Investigational Site Number 032044	Olivos
Argentina	Investigational Site Number 032004	Quilmes
Argentina	Investigational Site Number 032025	Rafaela
Argentina	Investigational Site Number 032035	Ramos Mejia
Argentina	Investigational Site Number 032039	Resistencia
Argentina	Investigational Site Number 032024	Rosario
Argentina	Investigational Site Number 032028	Rosario
Argentina	Investigational Site Number 032053	Salta
Argentina	Investigational Site Number 032037	San Isidro
Argentina	Investigational Site Number 032013	San Martin
Argentina	Investigational Site Number 032052	San Martin
Argentina	Investigational Site Number 032002	San Miguel De Tucuman
Argentina	Investigational Site Number 032034	San Miguel De Tucuman
Argentina	Investigational Site Number 032006	San Nicolas
Argentina	Investigational Site Number 032003	Santa Fe
Argentina	Investigational Site Number 032043	Santa Fe
Argentina	Investigational Site Number 032051	Santa Rosa
Argentina	Investigational Site Number 032047	Santiago Del Estero
Argentina	Investigational Site Number 032029	Venado Tuerto
Argentina	Investigational Site Number 032022	Villa Maria
Argentina	Investigational Site Number 032015	Zarate
Australia	Investigational Site Number 036002	Ashford
Australia	Investigational Site Number 036023	Auchenflower
Australia	Investigational Site Number 036024	Ballarat
Australia	Investigational Site Number 036020	Bedford Park
Australia	Investigational Site Number 036015	Bruce
Australia	Investigational Site Number 036026	Cairns
Australia	Investigational Site Number 036005	Chermside
Australia	Investigational Site Number 036008	Chermside
Australia	Investigational Site Number 036011	Coffs Harbour
Australia	Investigational Site Number 036003	Concord
Australia	Investigational Site Number 036017	Elizabeth Vale
Australia	Investigational Site Number 036006	Fullarton
Australia	Investigational Site Number 036004	Gosford
Australia	Investigational Site Number 036019	Heidelberg West
Australia	Investigational Site Number 036027	Hobart
Australia	Investigational Site Number 036009	Kogarah
Australia	Investigational Site Number 036012	Mildura
Australia	Investigational Site Number 036028	Nambour
Australia	Investigational Site Number 036013	New Lambton
Australia	Investigational Site Number 036010	Perth
Australia	Investigational Site Number 036014	Prahran
Australia	Investigational Site Number 036018	Redcliffe
Australia	Investigational Site Number 036022	Richmond
Australia	Investigational Site Number 036025	Woodville South
Australia	Investigational Site Number 036021	Woolloongabba
Austria	Investigational Site Number 040004	Feldkirch
Austria	Investigational Site Number 040007	Graz
Austria	Investigational Site Number 040001	Salzburg
Austria	Investigational Site Number 040002	Wien
Austria	Investigational Site Number 040003	Wien
Austria	Investigational Site Number 040006	Wien
Belgium	Investigational Site Number 056016	Aalst
Belgium	Investigational Site Number 056002	Antwerpen
Belgium	Investigational Site Number 056003	Antwerpen
Belgium	Investigational Site Number 056008	Bonheiden
Belgium	Investigational Site Number 056014	Brasschaat
Belgium	Investigational Site Number 056021	Brussels
Belgium	Investigational Site Number 056004	Bruxelles
Belgium	Investigational Site Number 056005	Bruxelles
Belgium	Investigational Site Number 056017	Edegem
Belgium	Investigational Site Number 056024	Genk
Belgium	Investigational Site Number 056007	Gent
Belgium	Investigational Site Number 056018	Gent
Belgium	Investigational Site Number 056020	La Louviere
Belgium	Investigational Site Number 056009	Leuven
Belgium	Investigational Site Number 056015	Liège
Belgium	Investigational Site Number 056010	Mechelen
Belgium	Investigational Site Number 056013	Mol
Belgium	Investigational Site Number 056001	Ottignies
Belgium	Investigational Site Number 056012	Overpelt
Belgium	Investigational Site Number 056006	Roeselare
Belgium	Investigational Site Number 056019	Tienen
Bosnia and Herzegovina	Investigational Site Number 070001	Banja Luka
Bosnia and Herzegovina	Investigational Site Number 070002	Banja Luka
Bosnia and Herzegovina	Investigational Site Number 070011	Bihac
Bosnia and Herzegovina	Investigational Site Number 070003	Mostar
Bosnia and Herzegovina	Investigational Site Number 070004	Mostar
Bosnia and Herzegovina	Investigational Site Number 070005	Sarajevo
Bosnia and Herzegovina	Investigational Site Number 070007	Sarajevo
Bosnia and Herzegovina	Investigational Site Number 070010	Sarajevo
Bosnia and Herzegovina	Investigational Site Number 070008	Tuzla
Bosnia and Herzegovina	Investigational Site Number 070009	Tuzla
Bosnia and Herzegovina	Investigational Site Number 070006	Zenica
Brazil	Investigational Site Number 076029	Aparecida De Goiania
Brazil	Investigational Site Number 076032	Belem
Brazil	Investigational Site Number 076004	Belo Horizonte
Brazil	Investigational Site Number 076017	Belo Horizonte
Brazil	Investigational Site Number 076022	Belo Horizonte
Brazil	Investigational Site Number 076038	Belo Horizonte
Brazil	Investigational Site Number 076002	Blumenau
Brazil	Investigational Site Number 076007	Brasilia
Brazil	Investigational Site Number 076011	Brasilia
Brazil	Investigational Site Number 076003	Campina Grande Do Sul
Brazil	Investigational Site Number 076006	Campinas
Brazil	Investigational Site Number 076040	Canoas
Brazil	Investigational Site Number 076005	Curitiba
Brazil	Investigational Site Number 076033	Curitiba
Brazil	Investigational Site Number 076008	Fortaleza
Brazil	Investigational Site Number 076009	Fortaleza
Brazil	Investigational Site Number 076012	Goiania
Brazil	Investigational Site Number 076021	Goiania
Brazil	Investigational Site Number 076019	Passo Fundo
Brazil	Investigational Site Number 076018	Pelotas
Brazil	Investigational Site Number 076001	Porto Alegre
Brazil	Investigational Site Number 076014	Porto Alegre
Brazil	Investigational Site Number 076024	Porto Alegre
Brazil	Investigational Site Number 076026	Porto Alegre
Brazil	Investigational Site Number 076027	Porto Alegre
Brazil	Investigational Site Number 076035	Riberao Preto
Brazil	Investigational Site Number 076010	Rio De Janeiro
Brazil	Investigational Site Number 076015	Salvador
Brazil	Investigational Site Number 076041	Salvador
Brazil	Investigational Site Number 076036	Santo Andre
Brazil	Investigational Site Number 076031	Sao Bernardo Do Campo
Brazil	Investigational Site Number 076020	Sao Jose Do Rio Preto
Brazil	Investigational Site Number 076030	Sao Jose Do Rio Preto
Brazil	Investigational Site Number 076013	Sao Paulo
Brazil	Investigational Site Number 076023	Sao Paulo
Brazil	Investigational Site Number 076025	Sao Paulo
Brazil	Investigational Site Number 076028	Sao Paulo
Brazil	Investigational Site Number 076039	Sao Paulo
Brazil	Investigational Site Number 076042	Sao Paulo
Brazil	Investigational Site Number 076016	Tatuí
Brazil	Investigational Site Number 076034	Uberlandia
Bulgaria	Investigational Site Number 100020	Blagoevgrad
Bulgaria	Investigational Site Number 100012	Burgas
Bulgaria	Investigational Site Number 100011	Pazardzhik
Bulgaria	Investigational Site Number 100013	Pleven
Bulgaria	Investigational Site Number 100018	Pleven
Bulgaria	Investigational Site Number 100005	Plovdiv
Bulgaria	Investigational Site Number 100015	Sandanski
Bulgaria	Investigational Site Number 100023	Smoljan
Bulgaria	Investigational Site Number 100001	Sofia
Bulgaria	Investigational Site Number 100003	Sofia
Bulgaria	Investigational Site Number 100004	Sofia
Bulgaria	Investigational Site Number 100007	Sofia
Bulgaria	Investigational Site Number 100010	Sofia
Bulgaria	Investigational Site Number 100016	Sofia
Bulgaria	Investigational Site Number 100017	Sofia
Bulgaria	Investigational Site Number 100019	Sofia
Bulgaria	Investigational Site Number 100022	Varna
Bulgaria	Investigational Site Number 100014	Veliko Tarnovo
Canada	Investigational Site Number 124033	Calgary
Canada	Investigational Site Number 124013	Cambridge
Canada	Investigational Site Number 124017	Cambridge
Canada	Investigational Site Number 124016	Edmonton
Canada	Investigational Site Number 124019	Edmonton
Canada	Investigational Site Number 124026	Edmonton
Canada	Investigational Site Number 124027	Granby
Canada	Investigational Site Number 124002	Halifax
Canada	Investigational Site Number 124051	Hamilton
Canada	Investigational Site Number 124043	Joliette
Canada	Investigational Site Number 124045	Kitchener
Canada	Investigational Site Number 124053	Levis
Canada	Investigational Site Number 124015	Longueuil
Canada	Investigational Site Number 124004	Moncton
Canada	Investigational Site Number 124032	Montreal
Canada	Investigational Site Number 124036	Montreal
Canada	Investigational Site Number 124040	Montreal
Canada	Investigational Site Number 124042	Montreal
Canada	Investigational Site Number 124028	New Westminster
Canada	Investigational Site Number 124008	Newmarket
Canada	Investigational Site Number 124005	Oshawa
Canada	Investigational Site Number 124007	Ottawa
Canada	Investigational Site Number 124006	Penticton
Canada	Investigational Site Number 124012	Red Deer
Canada	Investigational Site Number 124054	Saint-Jerome
Canada	Investigational Site Number 124024	Sainte-Foy
Canada	Investigational Site Number 124035	Scarborough
Canada	Investigational Site Number 124047	Sherbrooke
Canada	Investigational Site Number 124025	St-Georges
Canada	Investigational Site Number 124044	St. Catherines
Canada	Investigational Site Number 124021	St. John
Canada	Investigational Site Number 124034	St. John'S
Canada	Investigational Site Number 124009	Surrey
Canada	Investigational Site Number 124022	Sydney
Canada	Investigational Site Number 124048	Thetford Mines
Canada	Investigational Site Number 124037	Thunder Bay
Canada	Investigational Site Number 124001	Toronto
Canada	Investigational Site Number 124049	Trois-Rivieres
Canada	Investigational Site Number 124039	Vancouver
Canada	Investigational Site Number 124023	Victoria
Canada	Investigational Site Number 124041	Victoria
Canada	Investigational Site Number 124038	Winnipeg
Chile	Investigational Site Number 152013	Concepcion
Chile	Investigational Site Number 152003	Osorno
Chile	Investigational Site Number 152017	Punta Arenas
Chile	Investigational Site Number 152001	Santiago
Chile	Investigational Site Number 152004	Santiago
Chile	Investigational Site Number 152006	Santiago
Chile	Investigational Site Number 152007	Santiago
Chile	Investigational Site Number 152011	Santiago
Chile	Investigational Site Number 152012	Santiago
Chile	Investigational Site Number 152014	Santiago
Chile	Investigational Site Number 152015	Santiago
Chile	Investigational Site Number 152016	Santiago
Chile	Investigational Site Number 152019	Santiago
Chile	Investigational Site Number 152009	Talca
Chile	Investigational Site Number 152002	Temuco
Chile	Investigational Site Number 152008	Valdivia
Chile	Investigational Site Number 152010	Viña Del Mar
Chile	Investigational Site Number 152018	Viña Del Mar
China	Investigational Site Number 156022	Baotou
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156002	Beijing
China	Investigational Site Number 156003	Beijing
China	Investigational Site Number 156004	Beijing
China	Investigational Site Number 156005	Beijing
China	Investigational Site Number 156006	Beijing
China	Investigational Site Number 156009	Beijing
China	Investigational Site Number 156082	Beijing
China	Investigational Site Number 156013	Changchun
China	Investigational Site Number 156064	Changchun
China	Investigational Site Number 156052	Changsha
China	Investigational Site Number 156053	Changsha
China	Investigational Site Number 156088	Changsha
China	Investigational Site Number 156057	Chongqing
China	Investigational Site Number 156070	Fuzhou
China	Investigational Site Number 156079	Fuzhou
China	Investigational Site Number 156059	Guangzhou
China	Investigational Site Number 156060	Guangzhou
China	Investigational Site Number 156061	Guangzhou
China	Investigational Site Number 156071	Guangzhou
China	Investigational Site Number 156072	Guiyang
China	Investigational Site Number 156046	Hangzhou
China	Investigational Site Number 156047	Hangzhou
China	Investigational Site Number 156048	Hangzhou
China	Investigational Site Number 156068	Hangzhou
China	Investigational Site Number 156077	Hangzhou
China	Investigational Site Number 156078	Hangzhou
China	Investigational Site Number 156020	Hohhot
China	Investigational Site Number 156031	Jinan
China	Investigational Site Number 156032	Jinan
China	Investigational Site Number 156027	Lanzhou
China	Investigational Site Number 156074	Lanzhou
China	Investigational Site Number 156081	Luzhou
China	Investigational Site Number 156054	Nanchang
China	Investigational Site Number 156055	Nanchang
China	Investigational Site Number 156034	Nanjing
China	Investigational Site Number 156035	Nanjing
China	Investigational Site Number 156038	Shanghai
China	Investigational Site Number 156039	Shanghai
China	Investigational Site Number 156040	Shanghai
China	Investigational Site Number 156043	Shanghai
China	Investigational Site Number 156044	Shanghai
China	Investigational Site Number 156076	Shanghai
China	Investigational Site Number 156016	Shenyang
China	Investigational Site Number 156017	Shenyang
China	Investigational Site Number 156073	Shenzhen
China	Investigational Site Number 156084	Shenzhen
China	Investigational Site Number 156063	Siping
China	Investigational Site Number 156037	Suzhou
China	Investigational Site Number 156025	Tianjin
China	Investigational Site Number 156066	Tianjin
China	Investigational Site Number 156067	Tianjin
China	Investigational Site Number 156083	Tianjin
China	Investigational Site Number 156065	Wenzhou
China	Investigational Site Number 156051	Wuhan
China	Investigational Site Number 156087	Wuhan
China	Investigational Site Number 156029	Xi'An
China	Investigational Site Number 156086	Xi'An
China	Investigational Site Number 156062	Xuzhou
China	Investigational Site Number 156014	Yanji
China	Investigational Site Number 156075	Yueyang
China	Investigational Site Number 156080	Zhanjiang
Colombia	Investigational Site Number 170006	Armenia
Colombia	Investigational Site Number 170003	Barranquilla
Colombia	Investigational Site Number 170011	Barranquilla
Colombia	Investigational Site Number 170013	Barranquilla
Colombia	Investigational Site Number 170016	Bogota
Colombia	Investigational Site Number 170018	Bogota
Colombia	Investigational Site Number 170022	Bogota D.C.
Colombia	Investigational Site Number 170001	Cali
Colombia	Investigational Site Number 170010	Cali
Colombia	Investigational Site Number 170004	Cartagena
Colombia	Investigational Site Number 170017	Cartagena
Colombia	Investigational Site Number 170008	Espinal - Tolima
Colombia	Investigational Site Number 170005	Floridablanca
Colombia	Investigational Site Number 170002	Manizales
Colombia	Investigational Site Number 170007	Medellin
Colombia	Investigational Site Number 170009	Medellin
Colombia	Investigational Site Number 170021	Medellin
Croatia	Investigational Site Number 191013	Dubrovnik
Croatia	Investigational Site Number 191017	Krapinske Toplice
Croatia	Investigational Site Number 191009	Opatija
Croatia	Investigational Site Number 191006	Rijeka
Croatia	Investigational Site Number 191012	Slavonski Brod
Croatia	Investigational Site Number 191003	Varazdin
Croatia	Investigational Site Number 191001	Zagreb
Croatia	Investigational Site Number 191002	Zagreb
Croatia	Investigational Site Number 191005	Zagreb
Croatia	Investigational Site Number 191007	Zagreb
Croatia	Investigational Site Number 191008	Zagreb
Croatia	Investigational Site Number 191010	Zagreb
Croatia	Investigational Site Number 191011	Zagreb
Croatia	Investigational Site Number 191015	Zagreb
Croatia	Investigational Site Number 191016	Zagreb
Croatia	Investigational Site Number 191018	Zagreb
Czechia	Investigational Site Number 203003	Brno
Czechia	Investigational Site Number 203020	Ceska Lipa
Czechia	Investigational Site Number 203025	Cesky Krumlov
Czechia	Investigational Site Number 203023	Hodonin
Czechia	Investigational Site Number 203006	Hradec Kralove
Czechia	Investigational Site Number 203005	Kladno
Czechia	Investigational Site Number 203019	Kladno
Czechia	Investigational Site Number 203008	Kromeriz
Czechia	Investigational Site Number 203015	Liberec
Czechia	Investigational Site Number 203024	Marianske Lazne
Czechia	Investigational Site Number 203013	Olomouc
Czechia	Investigational Site Number 203016	Ostrava
Czechia	Investigational Site Number 203014	Pardubice
Czechia	Investigational Site Number 203018	Plzen
Czechia	Investigational Site Number 203011	Praha 10
Czechia	Investigational Site Number 203017	Praha 2
Czechia	Investigational Site Number 203004	Praha 4
Czechia	Investigational Site Number 203021	Praha 4
Czechia	Investigational Site Number 203012	Praha 5
Czechia	Investigational Site Number 203007	Praha 5 - Motol
Czechia	Investigational Site Number 203009	Rakovnik
Czechia	Investigational Site Number 203010	Zlin
Denmark	Investigational Site Number 208016	Aabenraa
Denmark	Investigational Site Number 208012	Aalborg
Denmark	Investigational Site Number 208011	Aarhus N
Denmark	Investigational Site Number 208002	Copenhagen
Denmark	Investigational Site Number 208003	Glostrup
Denmark	Investigational Site Number 208007	Hellerup
Denmark	Investigational Site Number 208006	Herning
Denmark	Investigational Site Number 208018	Hillerød
Denmark	Investigational Site Number 208014	Holbaek
Denmark	Investigational Site Number 208013	Hvidovre
Denmark	Investigational Site Number 208004	Køge
Denmark	Investigational Site Number 208017	Næstved
Denmark	Investigational Site Number 208009	Odense C
Denmark	Investigational Site Number 208015	Silkeborg
Denmark	Investigational Site Number 208008	Slagelse
Denmark	Investigational Site Number 208001	Vejle
Denmark	Investigational Site Number 208010	Viborg
Estonia	Investigational Site Number 233007	Pärnu
Estonia	Investigational Site Number 233001	Tallinn
Estonia	Investigational Site Number 233002	Tallinn
Estonia	Investigational Site Number 233004	Tallinn
Estonia	Investigational Site Number 233005	Tallinn
Estonia	Investigational Site Number 233003	Tartu
Estonia	Investigational Site Number 233006	Viljandimaa
Finland	Investigational Site Number 246004	Helsinki
Finland	Investigational Site Number 246001	Oulu
Finland	Investigational Site Number 246003	Tampere
Finland	Investigational Site Number 246002	Turku
France	Investigational Site Number 250003	Besancon
France	Investigational Site Number 250007	Brest Cedex
France	Investigational Site Number 250010	Cambrai Cedex
France	Investigational Site Number 250018	Clermont-Ferrand Cedex 1
France	Investigational Site Number 250021	Compiegne
France	Investigational Site Number 250002	Dijon
France	Investigational Site Number 250001	Grenoble
France	Investigational Site Number 250009	Limoges Cedex 1
France	Investigational Site Number 250019	Marseille
France	Investigational Site Number 250008	Massy
France	Investigational Site Number 250005	Montfermeil
France	Investigational Site Number 250023	Montpellier Cedex 5
France	Investigational Site Number 250025	Nantes
France	Investigational Site Number 250017	Nice Cedex 01
France	Investigational Site Number 250004	Paris
France	Investigational Site Number 250012	Paris
France	Investigational Site Number 250020	Paris
France	Investigational Site Number 250015	Paris Cedex 12
France	Investigational Site Number 250011	Pau
France	Investigational Site Number 250016	Pessac
France	Investigational Site Number 250026	Rouen
France	Investigational Site Number 250022	Strasbourg Cedex
Georgia	Investigational Site Number 268004	Batumi
Georgia	Investigational Site Number 268001	Kutaisi
Georgia	Investigational Site Number 268002	Tbilisi
Georgia	Investigational Site Number 268003	Tbilisi
Georgia	Investigational Site Number 268005	Tbilisi
Georgia	Investigational Site Number 268008	Tbilisi
Georgia	Investigational Site Number 268009	Tbilisi
Germany	Investigational Site Number 276013	Aachen
Germany	Investigational Site Number 276019	Bad Krozingen
Germany	Investigational Site Number 276008	Berlin
Germany	Investigational Site Number 276025	Berlin
Germany	Investigational Site Number 276039	Berlin
Germany	Investigational Site Number 276040	Berlin
Germany	Investigational Site Number 276051	Berlin
Germany	Investigational Site Number 276054	Bernau
Germany	Investigational Site Number 276037	Bielefeld
Germany	Investigational Site Number 276009	Bonn
Germany	Investigational Site Number 276016	Bonn
Germany	Investigational Site Number 276001	Dortmund
Germany	Investigational Site Number 276006	Dortmund
Germany	Investigational Site Number 276031	Dortmund
Germany	Investigational Site Number 276050	Dresden
Germany	Investigational Site Number 276024	Eschweiler
Germany	Investigational Site Number 276028	Essen
Germany	Investigational Site Number 276036	Frankfurt Am Main
Germany	Investigational Site Number 276012	Freiburg
Germany	Investigational Site Number 276030	Halle/Saale
Germany	Investigational Site Number 276017	Hamburg
Germany	Investigational Site Number 276027	Hamburg
Germany	Investigational Site Number 276032	Hamburg
Germany	Investigational Site Number 276029	Hamm
Germany	Investigational Site Number 276052	Haßloch
Germany	Investigational Site Number 276014	Heidelberg
Germany	Investigational Site Number 276023	Homburg/Saar
Germany	Investigational Site Number 276035	Kassel
Germany	Investigational Site Number 276046	Leipzig
Germany	Investigational Site Number 276020	Limburg
Germany	Investigational Site Number 276026	Lippstadt
Germany	Investigational Site Number 276044	Lübeck
Germany	Investigational Site Number 276021	Magdeburg
Germany	Investigational Site Number 276015	Mainz
Germany	Investigational Site Number 276010	Marburg
Germany	Investigational Site Number 276018	Münster
Germany	Investigational Site Number 276042	Nürnberg
Germany	Investigational Site Number 276048	Peine
Germany	Investigational Site Number 276053	Rotenburg An Der Fulda
Germany	Investigational Site Number 276045	Rüdersdorf Bei Berlin
Germany	Investigational Site Number 276002	Stuttgart
Germany	Investigational Site Number 276033	Warendorf
Greece	Investigational Site Number 300001	Athens
Greece	Investigational Site Number 300002	Athens
Greece	Investigational Site Number 300007	Athens
Greece	Investigational Site Number 300008	Chios
Greece	Investigational Site Number 300013	Haidari
Greece	Investigational Site Number 300010	Heraklion
Greece	Investigational Site Number 300005	Ioannina
Greece	Investigational Site Number 300003	Marousi
Greece	Investigational Site Number 300006	N. Ionia
Greece	Investigational Site Number 300004	Patra
Greece	Investigational Site Number 300009	Thessaloniki
Greece	Investigational Site Number 300011	Thessaloniki
Guatemala	Investigational Site Number 320001	Guatemala
Guatemala	Investigational Site Number 320002	Guatemala
Guatemala	Investigational Site Number 320003	Guatemala
Guatemala	Investigational Site Number 320004	Guatemala
Hong Kong	Investigational Site Number 344003	Hong Kong
Hong Kong	Investigational Site Number 344001	Shatin, Nt
Hungary	Investigational Site Number 348013	Balatonfüred
Hungary	Investigational Site Number 348002	Budapest
Hungary	Investigational Site Number 348005	Budapest
Hungary	Investigational Site Number 348006	Budapest
Hungary	Investigational Site Number 348012	Budapest
Hungary	Investigational Site Number 348008	Debrecen
Hungary	Investigational Site Number 348004	Eger
Hungary	Investigational Site Number 348003	Gyula
Hungary	Investigational Site Number 348010	Pécs
Hungary	Investigational Site Number 348009	Szeged
Hungary	Investigational Site Number 348007	Szekesfehervar
Hungary	Investigational Site Number 348011	Szombathely
Hungary	Investigational Site Number 348001	Zalaegerszeg
India	Investigational Site Number 356060	Ahmedabad
India	Investigational Site Number 356056	Aurangabad
India	Investigational Site Number 356018	Bangalore
India	Investigational Site Number 356025	Bangalore
India	Investigational Site Number 356026	Bangalore
India	Investigational Site Number 356028	Bangalore
India	Investigational Site Number 356083	Bangalore
India	Investigational Site Number 356084	Bangalore
India	Investigational Site Number 356103	Belgaum
India	Investigational Site Number 356019	Bikaner
India	Investigational Site Number 356012	Chennai
India	Investigational Site Number 356013	Chennai
India	Investigational Site Number 356081	Chennai
India	Investigational Site Number 356038	Delhi
India	Investigational Site Number 356093	Delhi
India	Investigational Site Number 356100	Gurgaon
India	Investigational Site Number 356101	Gurgaon
India	Investigational Site Number 356035	Hyderabad
India	Investigational Site Number 356082	Hyderabad
India	Investigational Site Number 356015	Jaipur
India	Investigational Site Number 356053	Karad
India	Investigational Site Number 356102	Karamsad
India	Investigational Site Number 356022	Kochi
India	Investigational Site Number 356106	Kolhapur
India	Investigational Site Number 356067	Kolkata
India	Investigational Site Number 356069	Kolkata
India	Investigational Site Number 356079	Kolkata
India	Investigational Site Number 356089	Ludhiana
India	Investigational Site Number 356095	Mangalore
India	Investigational Site Number 356057	Mumbai
India	Investigational Site Number 356071	Mumbai
India	Investigational Site Number 356007	Mysore
India	Investigational Site Number 356087	Nagpur
India	Investigational Site Number 356097	Nagpur
India	Investigational Site Number 356098	Nagpur
India	Investigational Site Number 356096	Nashik
India	Investigational Site Number 356031	New Delhi
India	Investigational Site Number 356055	New Delhi
India	Investigational Site Number 356041	Panaji
India	Investigational Site Number 356045	Pune
India	Investigational Site Number 356046	Pune
India	Investigational Site Number 356048	Pune
India	Investigational Site Number 356049	Pune
India	Investigational Site Number 356050	Pune
India	Investigational Site Number 356077	Pune
India	Investigational Site Number 356094	Pune
India	Investigational Site Number 356099	Pune
India	Investigational Site Number 356009	Secunderabad
India	Investigational Site Number 356032	Secunderabad
India	Investigational Site Number 356042	Secunderabad, Hyderabad
India	Investigational Site Number 356091	Surat
India	Investigational Site Number 356002	Vijayawada
India	Investigational Site Number 356105	Vijaywada
India	Investigational Site Number 356033	Visakhapatnam
India	Investigational Site Number 356039	Vishkhapattanam
India	Investigational Site Number 356104	Wardha
Israel	Investigational Site Number 376006	Afula
Israel	Investigational Site Number 376024	Afula
Israel	Investigational Site Number 376009	Ashkelon
Israel	Investigational Site Number 376012	Beer Sheva
Israel	Investigational Site Number 376011	Haifa
Israel	Investigational Site Number 376017	Haifa
Israel	Investigational Site Number 376018	Haifa
Israel	Investigational Site Number 376025	Haifa
Israel	Investigational Site Number 376007	Holon
Israel	Investigational Site Number 376021	Holon
Israel	Investigational Site Number 376005	Jerusalem
Israel	Investigational Site Number 376016	Jerusalem
Israel	Investigational Site Number 376027	Jerusalem
Israel	Investigational Site Number 376002	Kfar Saba
Israel	Investigational Site Number 376013	Kfar Saba
Israel	Investigational Site Number 376004	Nahariya
Israel	Investigational Site Number 376015	Nazareth
Israel	Investigational Site Number 376001	Petah-Tikva
Israel	Investigational Site Number 376019	Petah-Tikva
Israel	Investigational Site Number 376020	Rehovot
Israel	Investigational Site Number 376003	Safed
Israel	Investigational Site Number 376008	Safed
Israel	Investigational Site Number 376010	Tel Aviv
Israel	Investigational Site Number 376014	Tel Aviv
Israel	Investigational Site Number 376022	Tel Hashomer
Israel	Investigational Site Number 376023	Tiberias
Israel	Investigational Site Number 376026	Tzrifin
Italy	Investigational Site Number 380019	Augusta
Italy	Investigational Site Number 380017	Bergamo
Italy	Investigational Site Number 380008	Brescia
Italy	Investigational Site Number 380026	Brescia
Italy	Investigational Site Number 380012	Ferrara
Italy	Investigational Site Number 380027	Forlì
Italy	Investigational Site Number 380015	Livorno
Italy	Investigational Site Number 380033	Massa
Italy	Investigational Site Number 380003	Milano
Italy	Investigational Site Number 380005	Milano
Italy	Investigational Site Number 380030	Milano
Italy	Investigational Site Number 380025	Monza
Italy	Investigational Site Number 380001	Napoli
Italy	Investigational Site Number 380002	Napoli
Italy	Investigational Site Number 380021	Novara
Italy	Investigational Site Number 380009	Osio Sotto
Italy	Investigational Site Number 380007	Palermo
Italy	Investigational Site Number 380013	Perugia
Italy	Investigational Site Number 380031	Rho
Italy	Investigational Site Number 380014	Rimini
Italy	Investigational Site Number 380024	Roma
Italy	Investigational Site Number 380028	Seriate
Italy	Investigational Site Number 380032	Treviso
Italy	Investigational Site Number 380020	Vittorio Veneto
Japan	Investigational Site Number 392013	Amagasaki-Shi
Japan	Investigational Site Number 392041	Amagasaki-Shi
Japan	Investigational Site Number 392029	Fukuoka-Shi
Japan	Investigational Site Number 392019	Hachioji-Shi
Japan	Investigational Site Number 392026	Higashihiroshima-Shi
Japan	Investigational Site Number 392024	Higashiibaraki-Gun
Japan	Investigational Site Number 392003	Hiroshima-Shi
Japan	Investigational Site Number 392002	Itabashi-Ku
Japan	Investigational Site Number 392014	Itabashi-Ku
Japan	Investigational Site Number 392033	Izumisano-Shi
Japan	Investigational Site Number 392020	Kanazawa-Shi
Japan	Investigational Site Number 392015	Kitakyushu-Shi
Japan	Investigational Site Number 392017	Kobe-Shi
Japan	Investigational Site Number 392028	Kobe-Shi
Japan	Investigational Site Number 392037	Kobe-Shi
Japan	Investigational Site Number 392025	Koga-Shi
Japan	Investigational Site Number 392010	Komatsu-Shi
Japan	Investigational Site Number 392035	Komatsushima-Shi
Japan	Investigational Site Number 392023	Kumamoto-Shi
Japan	Investigational Site Number 392031	Kumamoto-Shi
Japan	Investigational Site Number 392039	Kure-Shi
Japan	Investigational Site Number 392012	Kurume-Shi
Japan	Investigational Site Number 392032	Kusatsu-Shi
Japan	Investigational Site Number 392001	Kyoto City
Japan	Investigational Site Number 392027	Minato-Ku
Japan	Investigational Site Number 392016	Morioka-Shi
Japan	Investigational Site Number 392005	Nagoya-Shi
Japan	Investigational Site Number 392022	Nerima-Ku
Japan	Investigational Site Number 392009	Osaka-Shi
Japan	Investigational Site Number 392011	Osaka-Shi
Japan	Investigational Site Number 392040	Osaka-Shi
Japan	Investigational Site Number 392004	Sagamihara-Shi
Japan	Investigational Site Number 392036	Sapporo-Shi
Japan	Investigational Site Number 392034	Shinagawa-Ku
Japan	Investigational Site Number 392018	Suita-Shi
Japan	Investigational Site Number 392030	Tokushima-Shi
Japan	Investigational Site Number 392008	Urasoe-Shi
Japan	Investigational Site Number 392006	Yokohama-Shi
Japan	Investigational Site Number 392021	Yokohama-Shi
Korea, Republic of	Investigational Site Number 410003	Busan
Korea, Republic of	Investigational Site Number 410013	Busan
Korea, Republic of	Investigational Site Number 410002	Daegu
Korea, Republic of	Investigational Site Number 410012	Goyang-Si
Korea, Republic of	Investigational Site Number 410001	Gwangju
Korea, Republic of	Investigational Site Number 410008	Seongnam
Korea, Republic of	Investigational Site Number 410004	Seoul
Korea, Republic of	Investigational Site Number 410006	Seoul
Korea, Republic of	Investigational Site Number 410007	Seoul
Korea, Republic of	Investigational Site Number 410010	Seoul
Korea, Republic of	Investigational Site Number 410011	Seoul
Korea, Republic of	Investigational Site Number 410009	Suwon
Korea, Republic of	Investigational Site Number 410005	Wonju
Latvia	Investigational Site Number 428004	Daugavpils
Latvia	Investigational Site Number 428002	Liepaja
Latvia	Investigational Site Number 428001	Riga
Latvia	Investigational Site Number 428005	Riga
Latvia	Investigational Site Number 428006	Riga
Latvia	Investigational Site Number 428003	Ventspils
Lithuania	Investigational Site Number 440004	Kaunas
Lithuania	Investigational Site Number 440005	Kaunas
Lithuania	Investigational Site Number 440008	Kaunas
Lithuania	Investigational Site Number 440009	Kaunas
Lithuania	Investigational Site Number 440001	Klaipeda
Lithuania	Investigational Site Number 440006	Klaipeda
Lithuania	Investigational Site Number 440002	Vilnius
Lithuania	Investigational Site Number 440003	Vilnius
Lithuania	Investigational Site Number 440007	Vilnius
Macedonia, The Former Yugoslav Republic of	Investigational Site Number 807005	Bitola
Macedonia, The Former Yugoslav Republic of	Investigational Site Number 807004	Shtip
Macedonia, The Former Yugoslav Republic of	Investigational Site Number 807001	Skopje
Macedonia, The Former Yugoslav Republic of	Investigational Site Number 807002	Skopje
Macedonia, The Former Yugoslav Republic of	Investigational Site Number 807003	Tetovo
Malaysia	Investigational Site Number 458004	Batu Caves
Malaysia	Investigational Site Number 458007	Kota Bharu
Malaysia	Investigational Site Number 458006	Kota Kinabalu
Malaysia	Investigational Site Number 458002	Kuala Lumpur
Malaysia	Investigational Site Number 458005	Kuala Lumpur
Malaysia	Investigational Site Number 458003	Kuching
Malaysia	Investigational Site Number 458001	Sungai Buloh
Mexico	Investigational Site Number 484005	Aguascalientes
Mexico	Investigational Site Number 484015	Aguascalientes
Mexico	Investigational Site Number 484004	Culiacan
Mexico	Investigational Site Number 484003	Durango
Mexico	Investigational Site Number 484006	Guadalajara
Mexico	Investigational Site Number 484010	Guadalajara
Mexico	Investigational Site Number 484008	Jalapa
Mexico	Investigational Site Number 484027	Mexico
Mexico	Investigational Site Number 484019	Mexico D.F.
Mexico	Investigational Site Number 484023	Mexico Df
Mexico	Investigational Site Number 484007	Monterrey
Mexico	Investigational Site Number 484011	Monterrey
Mexico	Investigational Site Number 484013	Monterrey
Mexico	Investigational Site Number 484018	Monterrey
Mexico	Investigational Site Number 484017	Morelia
Mexico	Investigational Site Number 484012	Oaxaca
Mexico	Investigational Site Number 484014	Querétaro
Mexico	Investigational Site Number 484009	San Luis Potosi
Mexico	Investigational Site Number 484002	Tijuana
Mexico	Investigational Site Number 484020	Toluca
Netherlands	Investigational Site Number 528006	Alkmaar
Netherlands	Investigational Site Number 528022	Amsterdam
Netherlands	Investigational Site Number 528026	Amsterdam
Netherlands	Investigational Site Number 528021	Apeldoorn
Netherlands	Investigational Site Number 528029	Arnhem
Netherlands	Investigational Site Number 528004	Breda
Netherlands	Investigational Site Number 528002	Delft
Netherlands	Investigational Site Number 528007	Eindhoven
Netherlands	Investigational Site Number 528032	Goes
Netherlands	Investigational Site Number 528012	Gouda
Netherlands	Investigational Site Number 528001	Groningen
Netherlands	Investigational Site Number 528025	Haarlem
Netherlands	Investigational Site Number 528023	Hardenberg
Netherlands	Investigational Site Number 528024	Heerenveen
Netherlands	Investigational Site Number 528016	Hoorn
Netherlands	Investigational Site Number 528019	Leeuwarden
Netherlands	Investigational Site Number 528008	Leiden
Netherlands	Investigational Site Number 528017	Meppel
Netherlands	Investigational Site Number 528030	Nieuwegein
Netherlands	Investigational Site Number 528011	Nijmegen
Netherlands	Investigational Site Number 528015	Purmerend
Netherlands	Investigational Site Number 528018	Roosendaal
Netherlands	Investigational Site Number 528014	Rotterdam
Netherlands	Investigational Site Number 528027	Rotterdam
Netherlands	Investigational Site Number 528005	Sneek
Netherlands	Investigational Site Number 528034	Tiel
Netherlands	Investigational Site Number 528013	Tilburg
Netherlands	Investigational Site Number 528028	Uden
Netherlands	Investigational Site Number 528009	Venlo
Netherlands	Investigational Site Number 528033	Zaandam
Netherlands	Investigational Site Number 528031	Zutphen
Netherlands	Investigational Site Number 528020	Zwolle
New Zealand	Investigational Site Number 554010	Auckland
New Zealand	Investigational Site Number 554001	Christchurch
New Zealand	Investigational Site Number 554006	Dunedin
New Zealand	Investigational Site Number 554004	Hamilton
New Zealand	Investigational Site Number 554011	Lower Hutt
New Zealand	Investigational Site Number 554005	Nelson
New Zealand	Investigational Site Number 554007	New Plymouth
New Zealand	Investigational Site Number 554002	Otahuhu
New Zealand	Investigational Site Number 554008	Palmerston North
New Zealand	Investigational Site Number 554012	Rotorua
New Zealand	Investigational Site Number 554009	Takapuna
New Zealand	Investigational Site Number 554003	Wellington
Norway	Investigational Site Number 578004	Arendal
Norway	Investigational Site Number 578013	Bergen
Norway	Investigational Site Number 578009	Hamar
Norway	Investigational Site Number 578006	Kongsvinger
Norway	Investigational Site Number 578003	Oslo
Norway	Investigational Site Number 578005	Oslo
Norway	Investigational Site Number 578012	Stavanger
Norway	Investigational Site Number 578002	Svelvik
Norway	Investigational Site Number 578011	Tynset
Peru	Investigational Site Number 604018	Arequipa
Peru	Investigational Site Number 604004	Callao
Peru	Investigational Site Number 604025	Callao
Peru	Investigational Site Number 604022	Cuzco
Peru	Investigational Site Number 604013	Ica
Peru	Investigational Site Number 604001	Lima
Peru	Investigational Site Number 604003	Lima
Peru	Investigational Site Number 604005	Lima
Peru	Investigational Site Number 604006	Lima
Peru	Investigational Site Number 604007	Lima
Peru	Investigational Site Number 604008	Lima
Peru	Investigational Site Number 604010	Lima
Peru	Investigational Site Number 604012	Lima
Peru	Investigational Site Number 604015	Lima
Peru	Investigational Site Number 604016	Lima
Peru	Investigational Site Number 604017	Lima
Peru	Investigational Site Number 604019	Lima
Peru	Investigational Site Number 604024	Lima
Peru	Investigational Site Number 604020	Piura
Peru	Investigational Site Number 604023	Trujillo
Philippines	Investigational Site Number 608012	Cavite
Philippines	Investigational Site Number 608003	Cebu City
Philippines	Investigational Site Number 608013	Cebu City
Philippines	Investigational Site Number 608010	Davao
Philippines	Investigational Site Number 608011	Davao City
Philippines	Investigational Site Number 608006	Iloilo City
Philippines	Investigational Site Number 608002	Makati City
Philippines	Investigational Site Number 608004	Manila
Philippines	Investigational Site Number 608014	Manila
Philippines	Investigational Site Number 608005	Quezon
Philippines	Investigational Site Number 608001	Quezon City
Philippines	Investigational Site Number 608009	Quezon City
Philippines	Investigational Site Number 608008	San Juan
Poland	Investigational Site Number 616026	Bydgoszcz
Poland	Investigational Site Number 616029	Bydgoszcz
Poland	Investigational Site Number 616010	Chrzanow
Poland	Investigational Site Number 616036	Czeladz
Poland	Investigational Site Number 616015	Gdansk
Poland	Investigational Site Number 616034	Gdansk
Poland	Investigational Site Number 616005	Gdynia
Poland	Investigational Site Number 616033	Gdynia
Poland	Investigational Site Number 616035	Gdynia
Poland	Investigational Site Number 616037	Grodzisk Mazowiecki
Poland	Investigational Site Number 616030	Jelenia Gora
Poland	Investigational Site Number 616002	Krakow
Poland	Investigational Site Number 616031	Krakow
Poland	Investigational Site Number 616012	Leczna
Poland	Investigational Site Number 616017	Legnica
Poland	Investigational Site Number 616019	Lodz
Poland	Investigational Site Number 616016	Lubin
Poland	Investigational Site Number 616021	Olawa
Poland	Investigational Site Number 616039	Olsztyn
Poland	Investigational Site Number 616003	Plock
Poland	Investigational Site Number 616011	Poznan
Poland	Investigational Site Number 616018	Pulawy
Poland	Investigational Site Number 616006	Skierniewice
Poland	Investigational Site Number 616027	Sobotka
Poland	Investigational Site Number 616007	Sokolka
Poland	Investigational Site Number 616022	Swidnik
Poland	Investigational Site Number 616024	Szczecin
Poland	Investigational Site Number 616004	Torun
Poland	Investigational Site Number 616013	Torun
Poland	Investigational Site Number 616025	Torun
Poland	Investigational Site Number 616032	W?Grów
Poland	Investigational Site Number 616008	Warszawa
Poland	Investigational Site Number 616020	Warszawa
Poland	Investigational Site Number 616038	Warszawa
Poland	Investigational Site Number 616040	Warszawa
Poland	Investigational Site Number 616041	Wroclaw
Portugal	Investigational Site Number 620004	Almada
Portugal	Investigational Site Number 620005	Aveiro
Portugal	Investigational Site Number 620008	Coimbra
Portugal	Investigational Site Number 620011	Coimbra
Portugal	Investigational Site Number 620001	Leiria
Portugal	Investigational Site Number 620003	Ponta Delgada
Portugal	Investigational Site Number 620002	Setubal
Portugal	Investigational Site Number 620010	Vila Franca De Xira
Portugal	Investigational Site Number 620006	Vila Nova Gaia
Romania	Investigational Site Number 642001	Braila
Romania	Investigational Site Number 642003	Bucharest
Romania	Investigational Site Number 642007	Bucuresti
Romania	Investigational Site Number 642008	Bucuresti
Romania	Investigational Site Number 642012	Bucuresti
Romania	Investigational Site Number 642021	Bucuresti
Romania	Investigational Site Number 642005	Buzau
Romania	Investigational Site Number 642013	Codlea
Romania	Investigational Site Number 642004	Constanta
Romania	Investigational Site Number 642002	Craiova
Romania	Investigational Site Number 642016	Craiova
Romania	Investigational Site Number 642010	Focsani
Romania	Investigational Site Number 642017	Iasi
Romania	Investigational Site Number 642006	Targoviste
Romania	Investigational Site Number 642015	Targu Mures
Romania	Investigational Site Number 642019	Targu Mures
Romania	Investigational Site Number 642018	Timisoara
Russian Federation	Investigational Site Number 643027	Barnaul
Russian Federation	Investigational Site Number 643037	Kazan
Russian Federation	Investigational Site Number 643013	Kemerovo
Russian Federation	Investigational Site Number 643020	Krasnodar
Russian Federation	Investigational Site Number 643053	Krasnodar
Russian Federation	Investigational Site Number 643002	Moscow
Russian Federation	Investigational Site Number 643004	Moscow
Russian Federation	Investigational Site Number 643011	Moscow
Russian Federation	Investigational Site Number 643016	Moscow
Russian Federation	Investigational Site Number 643022	Moscow
Russian Federation	Investigational Site Number 643023	Moscow
Russian Federation	Investigational Site Number 643028	Moscow
Russian Federation	Investigational Site Number 643029	Moscow
Russian Federation	Investigational Site Number 643031	Moscow
Russian Federation	Investigational Site Number 643033	Moscow
Russian Federation	Investigational Site Number 643044	Moscow
Russian Federation	Investigational Site Number 643043	Nizhny Novgorod
Russian Federation	Investigational Site Number 643034	Novosibirsk
Russian Federation	Investigational Site Number 643050	Novosibirsk
Russian Federation	Investigational Site Number 643052	Novosibirsk
Russian Federation	Investigational Site Number 643035	Omsk
Russian Federation	Investigational Site Number 643039	Perm
Russian Federation	Investigational Site Number 643008	Rostov-Na-Donu
Russian Federation	Investigational Site Number 643017	Ryazan
Russian Federation	Investigational Site Number 643006	Saint - Petersburg
Russian Federation	Investigational Site Number 643015	Saint - Petersburg
Russian Federation	Investigational Site Number 643001	Saint Petersburg
Russian Federation	Investigational Site Number 643007	Saint Petersburg
Russian Federation	Investigational Site Number 643040	Saint-Petersburg
Russian Federation	Investigational Site Number 643042	Saint-Petersburg
Russian Federation	Investigational Site Number 643051	Saint-Petersburg
Russian Federation	Investigational Site Number 643003	Saratov
Russian Federation	Investigational Site Number 643012	Saratov
Russian Federation	Investigational Site Number 643014	Saratov
Russian Federation	Investigational Site Number 643021	Saratov
Russian Federation	Investigational Site Number 643010	St-Petersburg
Russian Federation	Investigational Site Number 643030	St-Petersburg
Russian Federation	Investigational Site Number 643054	St-Petersburg
Russian Federation	Investigational Site Number 643049	Tomsk
Russian Federation	Investigational Site Number 643019	Tyumen
Russian Federation	Investigational Site Number 643025	Tyumen
Russian Federation	Investigational Site Number 643045	Voronezh
Russian Federation	Investigational Site Number 643009	Yaroslavl
Serbia	Investigational Site Number 688002	Belgrade
Serbia	Investigational Site Number 688003	Belgrade
Serbia	Investigational Site Number 688005	Belgrade
Serbia	Investigational Site Number 688006	Belgrade
Serbia	Investigational Site Number 688007	Belgrade
Serbia	Investigational Site Number 688008	Belgrade
Serbia	Investigational Site Number 688010	Belgrade
Serbia	Investigational Site Number 688011	Belgrade
Serbia	Investigational Site Number 688013	Belgrade
Serbia	Investigational Site Number 688015	Belgrade
Serbia	Investigational Site Number 688012	Kragujevac
Serbia	Investigational Site Number 688016	Leskovac
Serbia	Investigational Site Number 688004	Nis
Serbia	Investigational Site Number 688001	Niska Banja
Serbia	Investigational Site Number 688018	Pancevo
Serbia	Investigational Site Number 688009	Sremska Kamenica
Serbia	Investigational Site Number 688017	Sremska Mitrovica
Serbia	Investigational Site Number 688014	Valjevo
Singapore	Investigational Site Number 702001	Singapore
Singapore	Investigational Site Number 702002	Singapore
Singapore	Investigational Site Number 702003	Singapore
Slovakia	Investigational Site Number 703001	Bardejov
Slovakia	Investigational Site Number 703008	Bratislava
Slovakia	Investigational Site Number 703013	Bratislava
Slovakia	Investigational Site Number 703014	Bratislava
Slovakia	Investigational Site Number 703020	Bratislava
Slovakia	Investigational Site Number 703023	Dolny Kubin
Slovakia	Investigational Site Number 703002	Kosice
Slovakia	Investigational Site Number 703007	Kosice
Slovakia	Investigational Site Number 703009	Kosice
Slovakia	Investigational Site Number 703016	Kosice
Slovakia	Investigational Site Number 703019	Kosice
Slovakia	Investigational Site Number 703012	Kralovsky Chlmec
Slovakia	Investigational Site Number 703006	Lucenec
Slovakia	Investigational Site Number 703010	Lucenec
Slovakia	Investigational Site Number 703003	Nitra
Slovakia	Investigational Site Number 703004	Presov
Slovakia	Investigational Site Number 703018	Svidnik
Slovakia	Investigational Site Number 703022	Trebisov
Slovakia	Investigational Site Number 703005	Zilina
Slovenia	Investigational Site Number 705001	Celje
Slovenia	Investigational Site Number 705004	Izola
Slovenia	Investigational Site Number 705002	Jesenice
Slovenia	Investigational Site Number 705005	Ljubljana
Slovenia	Investigational Site Number 705006	Ljubljana
South Africa	Investigational Site Number 710017	Alberton
South Africa	Investigational Site Number 710007	Bellville
South Africa	Investigational Site Number 710015	Bloemfontein
South Africa	Investigational Site Number 710009	Cape Town
South Africa	Investigational Site Number 710010	Cape Town
South Africa	Investigational Site Number 710005	Chatsworth
South Africa	Investigational Site Number 710002	Durban
South Africa	Investigational Site Number 710004	Durban
South Africa	Investigational Site Number 710006	Durban
South Africa	Investigational Site Number 710012	Johannesburg
South Africa	Investigational Site Number 710014	Johannesburg
South Africa	Investigational Site Number 710019	Kempton Park
South Africa	Investigational Site Number 710011	Kimberley
South Africa	Investigational Site Number 710021	Kuils River
South Africa	Investigational Site Number 710018	Parow
South Africa	Investigational Site Number 710008	Pretoria
South Africa	Investigational Site Number 710016	Pretoria
South Africa	Investigational Site Number 710020	Stellenbosch
South Africa	Investigational Site Number 710013	Tongaat
South Africa	Investigational Site Number 710022	Western Cape
South Africa	Investigational Site Number 710003	Worcester
Spain	Investigational Site Number 724010	Alcalá De Henares
Spain	Investigational Site Number 724007	Almería
Spain	Investigational Site Number 724008	Barcelona
Spain	Investigational Site Number 724037	Barcelona
Spain	Investigational Site Number 724038	Barcelona
Spain	Investigational Site Number 724041	Barcelona
Spain	Investigational Site Number 724039	Cáceres
Spain	Investigational Site Number 724042	Córdoba
Spain	Investigational Site Number 724027	Fuenlabrada
Spain	Investigational Site Number 724002	Girona
Spain	Investigational Site Number 724013	Granada
Spain	Investigational Site Number 724032	Guadalajara
Spain	Investigational Site Number 724025	Hospitalet De Llobregat
Spain	Investigational Site Number 724003	Huelva
Spain	Investigational Site Number 724021	León
Spain	Investigational Site Number 724026	Lleida
Spain	Investigational Site Number 724006	Lugo
Spain	Investigational Site Number 724015	Madrid
Spain	Investigational Site Number 724017	Madrid
Spain	Investigational Site Number 724020	Madrid
Spain	Investigational Site Number 724030	Madrid
Spain	Investigational Site Number 724031	Madrid
Spain	Investigational Site Number 724033	Madrid
Spain	Investigational Site Number 724035	Majadahonda
Spain	Investigational Site Number 724016	Málaga
Spain	Investigational Site Number 724043	Málaga
Spain	Investigational Site Number 724036	Murcia
Spain	Investigational Site Number 724001	Oviedo
Spain	Investigational Site Number 724022	Sabadell
Spain	Investigational Site Number 724029	San Sebastian De Los Reyes
Spain	Investigational Site Number 724028	Santander
Spain	Investigational Site Number 724034	Santiago De Compostela
Spain	Investigational Site Number 724014	Sevilla
Spain	Investigational Site Number 724024	Tarragona
Spain	Investigational Site Number 724009	Valencia
Spain	Investigational Site Number 724011	Valencia
Spain	Investigational Site Number 724019	Valencia
Spain	Investigational Site Number 724023	Valladolid
Spain	Investigational Site Number 724005	Vigo
Spain	Investigational Site Number 724040	Zaragoza
Sri Lanka	Investigational Site Number 144001	Colombo
Sri Lanka	Investigational Site Number 144003	Colombo
Sri Lanka	Investigational Site Number 144005	Colombo
Sri Lanka	Investigational Site Number 144006	Colombo
Sri Lanka	Investigational Site Number 144010	Colombo
Sri Lanka	Investigational Site Number 144002	Colombo 7
Sri Lanka	Investigational Site Number 144004	Colombo 8
Sri Lanka	Investigational Site Number 144008	Kandy
Sri Lanka	Investigational Site Number 144009	Kurunegala
Sri Lanka	Investigational Site Number 144007	Ragama
Sweden	Investigational Site Number 752001	Falun
Sweden	Investigational Site Number 752016	Göteborg
Sweden	Investigational Site Number 752011	Halmstad
Sweden	Investigational Site Number 752006	Karlshamn
Sweden	Investigational Site Number 752008	Karlskrona
* Note: There are 1388 locations in all - only the first 1000 are shown.

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Georgia,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sri Lanka,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis	Adjusted means and standard errors at Month 4, 12 and 48 from multiple imputation approach (to account for missing data) followed by analyses of covariance (ANCOVA) model with the fixed categorical effect of treatment group and the continuous fixed covariate of baseline LDL-C value, including all available post-baseline data from Month 1 up to Month 48 regardless of status on- or off-treatment.	Baseline, Months 4, 12 and 48
Other	Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis	Adjusted Least-squares (LS) means and standard errors at Month 4, 12 and 48 were obtained from a mixed-effect model with repeated measures (MMRM) including available post-baseline on-treatment data from Month 1 up to Month 48 (i.e. up to 21 days after last injection).	Baseline, Months 4, 12 and 48
Primary	Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study	All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observed participants with outcome measure events during the study were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study	All CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death, non-fatal non-fatal MI, UA requiring hospitalization, or ischemia-driven coronary revascularization procedure. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study	All Major CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death and non-fatal MI. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any major CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study	All CV events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CV endpoint comprised of any non-fatal CHD event, any CV death and non-fatal IS. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CV event over time. Percentage of observed participants with outcome measure events during the study were reported.	From randomization up to 64 months
Secondary	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	All-cause mortality, non-fatal MI and non-fatal IS positively adjudicated by CEC in a blinded fashion, were used in the analysis of this endpoint. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of all-cause mortality, non-fatal MI and non-fatal IS over time. Percentage of observed participants with outcome measure events during the study were reported.	From randomization up to 64 months
Secondary	Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CHD death over time. Percentage of observed participants with CHD death (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months
Secondary	Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CV death over time. Percentage of observed participants with CV death (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months
Secondary	Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the all-cause death over time. Percentage of observed participants with all-cause death (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any non-fatal MI over time. Percentage of observed participants with any non-fatal MI (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of fatal or any non-fatal IS over time. Percentage of observed participants with fatal or any non-fatal IS (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any UA requiring hospitalization over time. Percentage of observed participants with any UA requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any ischemia-driven coronary revascularization procedure over time. Percentage of observed participants with any ischemia-driven coronary revascularization procedure (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months
Secondary	Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHF requiring hospitalization over time. Percentage of observed participants with any CHF requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.	From randomization up to 64 months