Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy (TAO)

April 4, 2016 updated by: Sanofi

Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy

Primary Objective:

To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide

Secondary Objectives:

To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide
To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide
To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide
To document the safety of Otamixaban as compared to UFH + eptifibatide
To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

Study Overview

Status

Completed

Conditions

Acute Coronary Syndrome

Intervention / Treatment

Detailed Description

Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study.

The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.

Study Type

Interventional

Enrollment (Actual)

13220

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Adrogue, Argentina, B1846DSK
    - Investigational Site Number 032048
  - Avellaneda, Argentina, 1870
    - Investigational Site Number 032013
  - Buenos Aires, Argentina, 1118
    - Investigational Site Number 032046
  - Buenos Aires, Argentina, C1118AAE
    - Investigational Site Number 032043
  - Buenos Aires, Argentina, C1181ACH
    - Investigational Site Number 032003
  - Buenos Aires, Argentina, C1425FSD
    - Investigational Site Number 032032
  - Caba, Argentina, B7400XAC
    - Investigational Site Number 032014
  - Capital Federal, Argentina, 1181
    - Investigational Site Number 032007
  - Capital Federal, Argentina, C1093AAS
    - Investigational Site Number 032039
  - Capital Federal, Argentina
    - Investigational Site Number 032045
  - Ciudad Autonoma De Bs.As, Argentina, 1428
    - Investigational Site Number 032029
  - Ciudad De Buenos Aires, Argentina, C1426BOR
    - Investigational Site Number 032036
  - Cordoba, Argentina, X5004BCL
    - Investigational Site Number 032044
  - Cordoba, Argentina, X5119XAA
    - Investigational Site Number 032010
  - Corrientes, Argentina, 3400
    - Investigational Site Number 032001
  - Florencio Varela, Argentina, B1888AAE
    - Investigational Site Number 032035
  - La Plata, Argentina, (B1900AXI)
    - Investigational Site Number 032018
  - La Plata, Argentina
    - Investigational Site Number 032027
  - Mendoza, Argentina, 5500
    - Investigational Site Number 032020
  - Olivos, Argentina, 1638
    - Investigational Site Number 032033
  - Pilar, Argentina, 1629
    - Investigational Site Number 032022
  - Resistencia, Argentina, 3500
    - Investigational Site Number 032023
  - Resistencia, Argentina
    - Investigational Site Number 032002
  - Rosario, Argentina, 2000
    - Investigational Site Number 032004
  - Rosario, Argentina, 2000
    - Investigational Site Number 032005
  - Rosario, Argentina, 2000
    - Investigational Site Number 032021
  - Rosario, Argentina, 2000
    - Investigational Site Number 032028
  - Rosario, Argentina, 2000
    - Investigational Site Number 032040
  - San Luis, Argentina, 5700
    - Investigational Site Number 032025
  - San Martin, Argentina, 1650
    - Investigational Site Number 032024
  - San Miguel De Tucuman, Argentina, T4000NIL
    - Investigational Site Number 032008
  - Santa Fe, Argentina, 3000
    - Investigational Site Number 032041
  - Santa Fe, Argentina, S3000FWO
    - Investigational Site Number 032006
Australia
- - Adelaide, Australia, 5000
    - Investigational Site Number 036008
  - Ballarat, Australia, 3353
    - Investigational Site Number 036004
  - Concord, Australia, 2137
    - Investigational Site Number 036010
  - Herston, Australia, 4029
    - Investigational Site Number 036001
  - Hobart, Australia, 7001
    - Investigational Site Number 036913
  - Liverpool, Australia, 2170
    - Investigational Site Number 036011
  - Prahran, Australia, 3004
    - Investigational Site Number 036003
Austria
- - Wien, Austria, 1090
    - Investigational Site Number 040002
  - Wien, Austria, 1160
    - Investigational Site Number 040001
Belarus
- - Gomel, Belarus, 246012
    - Investigational Site Number 112004
  - Minsk, Belarus, 220013
    - Investigational Site Number 112003
  - Minsk, Belarus, 220016
    - Investigational Site Number 112002
  - Minsk, Belarus, 220036
    - Investigational Site Number 112001
Belgium
- - Bonheiden, Belgium, 2820
    - Investigational Site Number 056001
  - Brugge, Belgium, 8000
    - Investigational Site Number 056007
  - Brussels, Belgium, 1020
    - Investigational Site Number 056003
  - Haine-Saint-Paul, Belgium, 7100
    - Investigational Site Number 056006
  - Leuven, Belgium, 3000
    - Investigational Site Number 056008
Brazil
- - Campinas, Brazil, 13015-001
    - Investigational Site Number 076025
  - Fortaleza, Brazil, 60864190
    - Investigational Site Number 076011
  - Marilia, Brazil, 17515-460
    - Investigational Site Number 076015
  - Maringa, Brazil, 87015-290
    - Investigational Site Number 076016
  - Passo Fundo, Brazil, 99010-080
    - Investigational Site Number 076013
  - Porto Alegre, Brazil, 90610-000
    - Investigational Site Number 076001
  - Porto Alegre, Brazil, 90035-001
    - Investigational Site Number 076009
  - Porto Alegre, Brazil, 90620-001
    - Investigational Site Number 076022
  - Porto Alegre, Brazil, 91350-250
    - Investigational Site Number 076004
  - Recife, Brazil, 50100-060
    - Investigational Site Number 076023
  - Recife, Brazil, 52051-380
    - Investigational Site Number 076030
  - Rio De Janeiro, Brazil, 20221903
    - Investigational Site Number 076027
  - Salvador, Brazil, 41148-900
    - Investigational Site Number 076029
  - Sao Jose Do Rio Preto, Brazil, 15015-210
    - Investigational Site Number 076014
  - Sao Jose Do Rio Preto, Brazil, 15090-000
    - Investigational Site Number 076002
  - Sao Paulo, Brazil, 01323-001
    - Investigational Site Number 076012
  - Sao Paulo, Brazil, 04012-180
    - Investigational Site Number 076020
  - Sao Paulo, Brazil, 05403-000
    - Investigational Site Number 076007
  - Uberlandia, Brazil, 38400-368
    - Investigational Site Number 076008
  - Votuporanga, Brazil, 15500-003
    - Investigational Site Number 076024
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - Investigational Site Number 100511
  - Kazanlak, Bulgaria, 6100
    - Investigational Site Number 100508
  - Pazardjik, Bulgaria, 4400
    - Investigational Site Number 100512
  - Pleven, Bulgaria, 5800
    - Investigational Site Number 100505
  - Ruse, Bulgaria
    - Investigational Site Number 100509
  - Sandanski, Bulgaria, 2800
    - Investigational Site Number 100510
  - Sofia, Bulgaria, 1202
    - Investigational Site Number 100501
  - Sofia, Bulgaria, 1407
    - Investigational Site Number 100502
  - Sofia, Bulgaria, 1431
    - Investigational Site Number 100503
  - Varna, Bulgaria, 9000
    - Investigational Site Number 100507
  - Veliko Tarnovo, Bulgaria, 5000
    - Investigational Site Number 100504
  - Yambol, Bulgaria, 8600
    - Investigational Site Number 100506
Canada
- - Gatineau, Canada, J8Y 1W7
    - Investigational Site Number 124005
  - Hamilton, Canada, L8L 2X2
    - Investigational Site Number 124006
  - Montreal, Canada, H2W 1T8
    - Investigational Site Number 124004
  - Quebec, Canada, G1V 4G5
    - Investigational Site Number 124001
  - Sherbrooke, Canada, J1H 5N4
    - Investigational Site Number 124007
  - St. John, Canada, E2L 4L2
    - Investigational Site Number 124009
  - Toronto, Canada, M5B 1W8
    - Investigational Site Number 124002
Chile
- - Antofagasta, Chile
    - Investigational Site Number 152003
  - Concepcion, Chile, 4070038
    - Investigational Site Number 152906
  - Iquique, Chile
    - Investigational Site Number 152005
  - Santiago, Chile, 751-0009
    - Investigational Site Number 152004
  - Santiago, Chile, 756-0171
    - Investigational Site Number 152001
  - Santiago, Chile, 820-7257
    - Investigational Site Number 152902
  - Santiago, Chile, 8380456
    - Investigational Site Number 152901
  - Santiago, Chile, 890-0085
    - Investigational Site Number 152903
  - Santiago, Chile
    - Investigational Site Number 152010
  - Santiago, Chile
    - Investigational Site Number 152012
  - Talcahuano, Chile, 427-0918
    - Investigational Site Number 152011
  - Temuco, Chile
    - Investigational Site Number 152908
  - Temuco, Chile
    - Investigational Site Number 152913
  - Valdivia, Chile
    - Investigational Site Number 152016
  - Valparaíso, Chile, 234-0207
    - Investigational Site Number 152912
  - Vina Del Mar, Chile
    - Investigational Site Number 152907
  - Viña Del Mar, Chile
    - Investigational Site Number 152910
Colombia
- - Barranquilla, Colombia
    - Investigational Site Number 170016
  - Bogota, Colombia
    - Investigational Site Number 170009
  - Bogotá, Colombia
    - Investigational Site Number 170011
  - Bucaramanga, Colombia
    - Investigational Site Number 170002
  - Cali, Colombia
    - Investigational Site Number 170012
  - Medellin, Colombia
    - Investigational Site Number 170001
  - Medellin, Colombia
    - Investigational Site Number 170003
  - Medellin, Colombia
    - Investigational Site Number 170017
Croatia
- - Slavonski Brod, Croatia, 35000
    - Investigational Site Number 191502
  - Zagreb, Croatia, 10000
    - Investigational Site Number 191503
  - Zagreb, Croatia, 10000
    - Investigational Site Number 191505
  - Zagreb, Croatia, 10000
    - Investigational Site Number 191506
Czech Republic
- - Brno, Czech Republic, 62500
    - Investigational Site Number 203005
  - Hradec Kralove, Czech Republic, 50005
    - Investigational Site Number 203903
  - Liberec, Czech Republic, 46063
    - Investigational Site Number 203902
  - Olomouc, Czech Republic, 77520
    - Investigational Site Number 203009
  - Ostrava - Poruba, Czech Republic, 70852
    - Investigational Site Number 203010
  - Praha 10, Czech Republic, 10034
    - Investigational Site Number 203001
  - Praha 2, Czech Republic, 12808
    - Investigational Site Number 203901
  - Praha 5, Czech Republic, 15006
    - Investigational Site Number 203007
  - Praha 5, Czech Republic, 15030
    - Investigational Site Number 203003
  - Usti Nad Labem, Czech Republic, 40113
    - Investigational Site Number 203002
  - Zlin, Czech Republic, 76275
    - Investigational Site Number 203006
Egypt
- - Cairo, Egypt, 11451
    - Investigational Site Number 818504
  - Cairo, Egypt, 11566
    - Investigational Site Number 818501
  - Cairo, Egypt
    - Investigational Site Number 818502
  - Giza, Egypt
    - Investigational Site Number 818503
Estonia
- - Tallinn, Estonia, 10138
    - Investigational Site Number 233001
  - Tallinn, Estonia, 13419
    - Investigational Site Number 233901
France
- - Avignon Cedex 2, France, 84082
    - Investigational Site Number 250016
  - Bayonne, France, 64100
    - Investigational Site Number 250010
  - Belfort Cedex, France, 90016
    - Investigational Site Number 250002
  - Besancon, France, 25030
    - Investigational Site Number 250001
  - Creteil, France, 94010
    - Investigational Site Number 250006
  - Dijon Cedex, France, 21034
    - Investigational Site Number 250003
  - Le Chesnay Cedex, France, 78187
    - Investigational Site Number 250013
  - Montfermeil, France, 93370
    - Investigational Site Number 250012
  - Mulhouse, France, 68067
    - Investigational Site Number 250005
  - Mulhouse, France, 68070
    - Investigational Site Number 250015
  - Paris, France, 75018
    - Investigational Site Number 250009
  - Pau, France, 64046
    - Investigational Site Number 250011
  - Rouen, France, 76031
    - Investigational Site Number 250007
  - Strasbourg, France, 67091
    - Investigational Site Number 250014
  - Toulouse Cedex 9, France, 31059
    - Investigational Site Number 250008
Germany
- - Berlin, Germany, 12559
    - Investigational Site Number 276022
  - Berlin, Germany, 13347
    - Investigational Site Number 276004
  - Berlin, Germany, 13353
    - Investigational Site Number 276024
  - Bonn, Germany, 53115
    - Investigational Site Number 276023
  - Frankfurt Am Main, Germany, 65929
    - Investigational Site Number 276006
  - Freiburg, Germany, 79106
    - Investigational Site Number 276901
  - Hamburg, Germany, 22041
    - Investigational Site Number 276003
  - Hamburg, Germany, 22527
    - Investigational Site Number 276902
  - Heidelberg, Germany, 69120
    - Investigational Site Number 276009
  - Heidenheim, Germany, 89522
    - Investigational Site Number 276904
  - Kassel, Germany, 34121
    - Investigational Site Number 276002
  - Langen, Germany, 63225
    - Investigational Site Number 276013
  - Mainz, Germany, 55131
    - Investigational Site Number 276001
  - Mönchengladbach, Germany, 41063
    - Investigational Site Number 276905
  - München, Germany, 81377
    - Investigational Site Number 276005
  - Rostock, Germany, 18057
    - Investigational Site Number 276018
Greece
- - Alexandroupolis, Greece, 68100
    - Investigational Site Number 300009
  - Athens, Greece, 10676
    - Investigational Site Number 300004
  - Athens, Greece, 11527
    - Investigational Site Number 300001
  - Athens, Greece, 11528
    - Investigational Site Number 300011
  - Chios, Greece, 82100
    - Investigational Site Number 300007
  - Larissa, Greece, 41110
    - Investigational Site Number 300008
  - Melissia, Greece, 151 27
    - Investigational Site Number 300003
  - N. Ionia, Greece, 14233
    - Investigational Site Number 300005
  - Patras, Greece, 26500
    - Investigational Site Number 300002
  - Thessaloniki, Greece, 546 36
    - Investigational Site Number 300010
  - Thessaloniki, Greece, 57010
    - Investigational Site Number 300006
Hong Kong
- - Chai Wan, Hong Kong
    - Investigational Site Number 344001
Hungary
- - Budapest, Hungary, 1027
    - Investigational Site Number 348003
  - Budapest, Hungary, 1096
    - Investigational Site Number 348008
  - Budapest, Hungary, 1122
    - Investigational Site Number 348002
  - Budapest, Hungary, 1134
    - Investigational Site Number 348004
  - Szeged, Hungary, 6720
    - Investigational Site Number 348009
  - Szekesfehervar, Hungary, 8000
    - Investigational Site Number 348007
  - Szolnok, Hungary, 5000
    - Investigational Site Number 348001
  - Szombathely, Hungary, 9700
    - Investigational Site Number 348005
  - Zalaegerszeg, Hungary, 8900
    - Investigational Site Number 348006
India
- - Ahmedabad, India, 380014
    - Investigational Site Number 356019
  - Ahmedabad, India, 380054
    - Investigational Site Number 356004
  - Ahmedabad, India, 380060
    - Investigational Site Number 356007
  - Allahabad, India, 211003
    - Investigational Site Number 356012
  - Bangalore, India, 560054
    - Investigational Site Number 356008
  - Chandigarh, India, 160062
    - Investigational Site Number 356020
  - Gurgaon, India, 122001
    - Investigational Site Number 356029
  - Gurgaon, India
    - Investigational Site Number 356027
  - Hyderabad, India, 500001
    - Investigational Site Number 356040
  - Hyderabad, India, 500055
    - Investigational Site Number 356046
  - Jaipur, India
    - Investigational Site Number 356014
  - Karamsad, India, 388325
    - Investigational Site Number 356003
  - Kochi, India, 682018
    - Investigational Site Number 356037
  - Kolkata, India, 700027
    - Investigational Site Number 356034
  - Madurai, India, 625107
    - Investigational Site Number 356039
  - Mangalore, India
    - Investigational Site Number 356018
  - Mumbai, India, 400050
    - Investigational Site Number 356021
  - Mumbai, India
    - Investigational Site Number 356016
  - Mumbai, India
    - Investigational Site Number 356031
  - Mumbai, India
    - Investigational Site Number 356032
  - Mysore, India, 570020
    - Investigational Site Number 356011
  - Nagpur, India
    - Investigational Site Number 356023
  - Nagpur, India, 440012
    - Investigational Site Number 356022
  - Nagpur, India, 440012
    - Investigational Site Number 356035
  - Nashik, India, 422005
    - Investigational Site Number 356036
  - New Delhi, India, 110 070.
    - Investigational Site Number 356025
  - New Delhi, India, 110060
    - Investigational Site Number 356001
  - New Delhi, India
    - Investigational Site Number 356026
  - Pune, India, 411004
    - Investigational Site Number 356010
  - Pune, India, 411004
    - Investigational Site Number 356033
  - Secunderabad, India, 500 003
    - Investigational Site Number 356024
  - Varanasi, India, 221010
    - Investigational Site Number 356002
  - Vijaywada, India, 520002
    - Investigational Site Number 356044
Indonesia
- - Bandung, Indonesia, 40161
    - Investigational Site Number 360505
  - Depok, Indonesia, 16514
    - Investigational Site Number 360501
  - Jakarta, Indonesia, 10430
    - Investigational Site Number 360506
  - Jakarta, Indonesia, 11420
    - Investigational Site Number 360503
  - Jakarta, Indonesia, 12950
    - Investigational Site Number 360502
Israel
- - Afula, Israel, 18101
    - Investigational Site Number 376005
  - Ashkelon, Israel, 78278
    - Investigational Site Number 376003
  - Hadera, Israel, 38100
    - Investigational Site Number 376011
  - Haifa, Israel, 31048
    - Investigational Site Number 376004
  - Haifa, Israel, 31096
    - Investigational Site Number 376009
  - Holon, Israel, 58100
    - Investigational Site Number 376010
  - Jerusalem, Israel, 91031
    - Investigational Site Number 376002
  - Jerusalem, Israel, 91120
    - Investigational Site Number 376013
  - Safed, Israel, 13100
    - Investigational Site Number 376007
  - Tel Aviv, Israel, 64239
    - Investigational Site Number 376008
  - Tel Hashomer, Israel, 52621
    - Investigational Site Number 376001
  - Tzrifin, Israel, 70300
    - Investigational Site Number 376012
Italy
- - Bergamo, Italy, 24127
    - Investigational Site Number 380902
  - Bologna, Italy, 40138
    - Investigational Site Number 380918
  - Brescia, Italy, 25123
    - Investigational Site Number 380904
  - Brescia, Italy, 25124
    - Investigational Site Number 380928
  - Castellanza, Italy, 21053
    - Investigational Site Number 380929
  - Catania, Italy, 95123
    - Investigational Site Number 380930
  - Catania, Italy, 95124
    - Investigational Site Number 380912
  - Cittadella, Italy, 35013
    - Investigational Site Number 380932
  - Conegliano, Italy, 31015
    - Investigational Site Number 380926
  - Empoli, Italy, 50053
    - Investigational Site Number 380909
  - Forlì, Italy, 47100
    - Investigational Site Number 380924
  - Livorno, Italy, 57123
    - Investigational Site Number 380908
  - Massa, Italy, 54100
    - Investigational Site Number 380923
  - Massa, Italy, 54100
    - Investigational Site Number 380935
  - Messina, Italy, 98100
    - Investigational Site Number 380933
  - Milano, Italy, 20138
    - Investigational Site Number 380910
  - Modena, Italy, 41041
    - Investigational Site Number 380905
  - Napoli, Italy, 88100
    - Investigational Site Number 380936
  - Perugia, Italy, 06132
    - Investigational Site Number 380901
  - Pescara, Italy, 65100
    - Investigational Site Number 380907
  - Pordenone, Italy, 33170
    - Investigational Site Number 380919
  - Reggio Emilia, Italy, 42100
    - Investigational Site Number 380916
  - Roma, Italy, 00168
    - Investigational Site Number 380931
  - Roma, Italy, 00189
    - Investigational Site Number 380917
  - Rovigo, Italy, 45100
    - Investigational Site Number 380927
  - Rozzano, Italy, 20089
    - Investigational Site Number 380921
  - Seriate, Italy, 24068
    - Investigational Site Number 380914
  - Treviso, Italy, 31100
    - Investigational Site Number 380925
Jordan
- - Amman, Jordan, 520248
    - Investigational Site Number 400501
  - Irbid, Jordan, 360001
    - Investigational Site Number 400502
Korea, Republic of
- - Busan, Korea, Republic of, 602-715
    - Investigational Site Number 410005
  - Busan, Korea, Republic of, 614-735
    - Investigational Site Number 410006
  - Daegu, Korea, Republic of, 700-712
    - Investigational Site Number 410002
  - Daegu, Korea, Republic of, 705-717
    - Investigational Site Number 410014
  - Daejeon, Korea, Republic of
    - Investigational Site Number 410017
  - Goyang, Korea, Republic of, 410-773
    - Investigational Site Number 410004
  - Guri, Korea, Republic of, 471-020
    - Investigational Site Number 410018
  - Gwangju, Korea, Republic of, 501-757
    - Investigational Site Number 410016
  - Seongnam, Korea, Republic of, 463-707
    - Investigational Site Number 410007
  - Seoul, Korea, Republic of, 110-744
    - Investigational Site Number 410008
  - Seoul, Korea, Republic of, 120-752
    - Investigational Site Number 410012
  - Seoul, Korea, Republic of, 130-709
    - Investigational Site Number 410011
  - Seoul, Korea, Republic of, 134-727
    - Investigational Site Number 410001
  - Seoul, Korea, Republic of, 137-701
    - Investigational Site Number 410009
  - Seoul, Korea, Republic of, 138-736
    - Investigational Site Number 410010
  - Seoul, Korea, Republic of, 152-703
    - Investigational Site Number 410003
  - Suwon, Korea, Republic of, 443-721
    - Investigational Site Number 410013
  - Wonju, Korea, Republic of, 220-701
    - Investigational Site Number 410015
Latvia
- - Daugavpils, Latvia, LV-5417
    - Investigational Site Number 428004
  - Liepaja, Latvia, LV-3414
    - Investigational Site Number 428002
  - Riga, Latvia, LV-1002
    - Investigational Site Number 428001
  - Riga, Latvia, LV-1038
    - Investigational Site Number 428003
Lebanon
- - Beirut, Lebanon, Beirut
    - Investigational Site Number 422502
  - Beirut, Lebanon
    - Investigational Site Number 422505
Lithuania
- - Kaunas, Lithuania, LT-50009
    - Investigational Site Number 440003
  - Siauliai, Lithuania, LT-76231
    - Investigational Site Number 440001
  - Vilnius, Lithuania, LT-08661
    - Investigational Site Number 440904
Macedonia, The Former Yugoslav Republic of
- - Skopje, Macedonia, The Former Yugoslav Republic of, 1109
    - Investigational Site Number 807501
Malaysia
- - Kuching, Malaysia, 93586
    - Investigational Site Number 458001
Mexico
- - Aguascalientes, Mexico, 20230
    - Investigational Site Number 484009
  - Aguascalientes, Mexico, 20230
    - Investigational Site Number 484907
  - Guadalajara, Mexico, 44100
    - Investigational Site Number 484902
  - Guadalajara, Mexico, 44670
    - Investigational Site Number 484015
  - Guadalajara, Mexico, CP 64630
    - Investigational Site Number 484901
  - Merida, Mexico, 97000
    - Investigational Site Number 484019
  - Mexico City, Mexico, 14000
    - Investigational Site Number 484003
  - Monterrey, Mexico, 64460
    - Investigational Site Number 484004
  - Morelia, Michoacan, Mexico, 58070
    - Investigational Site Number 484910
  - México Df, Mexico, 14080
    - Investigational Site Number 484914
  - Puebla, Mexico, 72460
    - Investigational Site Number 484020
  - Queretaro, Mexico, 76000
    - Investigational Site Number 484017
  - San Luis Potosi, Mexico, 72244
    - Investigational Site Number 484012
  - San Luis Potosi, Mexico, 78200
    - Investigational Site Number 484911
  - Xalapa, Mexico, 91020
    - Investigational Site Number 484013
Montenegro
- - Podgorica, Montenegro
    - Investigational Site Number 499501
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Investigational Site Number 528003
  - Arnhem, Netherlands, 6815 AD
    - Investigational Site Number 528005
  - Leeuwarden, Netherlands, 8934 AD
    - Investigational Site Number 528007
  - Nieuwegein, Netherlands, 3435 CM
    - Investigational Site Number 528004
  - Rotterdam, Netherlands, 3079 DZ
    - Investigational Site Number 528002
New Zealand
- - Auckland, New Zealand
    - Investigational Site Number 554004
  - Hamilton, New Zealand, 3200
    - Investigational Site Number 554001
  - Nelson, New Zealand, 7040
    - Investigational Site Number 554002
Norway
- - Arendal, Norway, 4809
    - Investigational Site Number 578903
  - Bergen, Norway, 5021
    - Investigational Site Number 578901
  - Stavanger, Norway, 4011
    - Investigational Site Number 578902
Panama
- - Panama, Panama
    - Investigational Site Number 591504
  - Panamá, Panama
    - Investigational Site Number 591502
Peru
- - Lambayeque, Peru
    - Investigational Site Number 604005
  - Lima, Peru, 051
    - Investigational Site Number 604002
  - Lima, Peru, 051
    - Investigational Site Number 604011
  - Lima, Peru, LIMA 01
    - Investigational Site Number 604014
  - Lima, Peru, LIMA 11
    - Investigational Site Number 604003
  - Lima, Peru, LIMA 13
    - Investigational Site Number 604017
  - Lima, Peru, LIMA 27
    - Investigational Site Number 604006
  - Lima, Peru, LIMA 31
    - Investigational Site Number 604012
  - Lima, Peru
    - Investigational Site Number 604008
Poland
- - Bialystok, Poland, 15-276
    - Investigational Site Number 616005
  - Bialystok, Poland, 15-276
    - Investigational Site Number 616038
  - Bydgoszcz, Poland, 85-168
    - Investigational Site Number 616017
  - Bytom, Poland, 41-902
    - Investigational Site Number 616009
  - Elblag, Poland, 82-300
    - Investigational Site Number 616040
  - Elk, Poland, 19-300
    - Investigational Site Number 616027
  - Gdansk, Poland, 80-952
    - Investigational Site Number 616023
  - Jelenia Gora, Poland, 58-506
    - Investigational Site Number 616032
  - Katowice, Poland, 40-635
    - Investigational Site Number 616037
  - Katowice, Poland, 40-635
    - Investigational Site Number 616046
  - Klodzko, Poland, 57-300
    - Investigational Site Number 616034
  - Krakow, Poland, 31 -202
    - Investigational Site Number 616045
  - Krakow, Poland, 31-501
    - Investigational Site Number 616002
  - Lodz, Poland, 91-347
    - Investigational Site Number 616029
  - Lomza, Poland, 18-400
    - Investigational Site Number 616004
  - Lubin, Poland, 59-301
    - Investigational Site Number 616024
  - Lublin, Poland, 20-954
    - Investigational Site Number 616041
  - Ostroleka, Poland, 07-400
    - Investigational Site Number 616016
  - Radom, Poland, 26-600
    - Investigational Site Number 616003
  - Radom, Poland, 26-610
    - Investigational Site Number 616047
  - Rybnik, Poland, 44-200
    - Investigational Site Number 616033
  - Tarnów, Poland, 33-100
    - Investigational Site Number 616019
  - Torun, Poland, 87-100
    - Investigational Site Number 616022
  - Walbrzych, Poland, 58-309
    - Investigational Site Number 616018
  - Warszawa, Poland, 02-507
    - Investigational Site Number 616014
  - Warszawa, Poland, 04-628
    - Investigational Site Number 616001
  - Wloclawek, Poland, 87-800
    - Investigational Site Number 616031
  - Wroclaw, Poland, 50-420
    - Investigational Site Number 616015
  - Zamosc, Poland, 22-400
    - Investigational Site Number 616020
Portugal
- - Almada, Portugal, 2801-951
    - Investigational Site Number 620010
  - Amadora, Portugal, 2720
    - Investigational Site Number 620006
  - Coimbra, Portugal, 3000-075
    - Investigational Site Number 620001
  - Coimbra, Portugal, 3041-801
    - Investigational Site Number 620002
  - Lisboa, Portugal, 1169-024
    - Investigational Site Number 620003
  - Ponta Delgada, Portugal, 9500-370
    - Investigational Site Number 620015
  - Setúbal, Portugal, 2910-446
    - Investigational Site Number 620004
  - Évora, Portugal, 7000
    - Investigational Site Number 620011
Romania
- - Brasov, Romania, 500059
    - Investigational Site Number 642002
  - Bucuresti, Romania, 011461
    - Investigational Site Number 642004
  - Bucuresti, Romania, 014461
    - Investigational Site Number 642001
  - Cluj Napoca, Romania, 400001
    - Investigational Site Number 642005
  - Targu-Mures, Romania, 20475
    - Investigational Site Number 642003
Russian Federation
- - Barnaul, Russian Federation, 656055
    - Investigational Site Number 643018
  - Ekaterinburg, Russian Federation, 620109
    - Investigational Site Number 643015
  - Kemerovo, Russian Federation, 650002
    - Investigational Site Number 643011
  - Krasnodar, Russian Federation, 350086
    - Investigational Site Number 643014
  - Krasnoyarsk, Russian Federation, 660022
    - Investigational Site Number 643021
  - Moscow, Russian Federation, 105229
    - Investigational Site Number 643005
  - Moscow, Russian Federation, 111539
    - Investigational Site Number 643004
  - Moscow, Russian Federation, 115446
    - Investigational Site Number 643020
  - Moscow, Russian Federation, 121359
    - Investigational Site Number 643003
  - Moscow, Russian Federation, 121552
    - Investigational Site Number 643001
  - Nizniy Novgorod, Russian Federation, 603005
    - Investigational Site Number 643016
  - Novosibirsk, Russian Federation, 630055
    - Investigational Site Number 643024
  - Saint-Peterburg, Russian Federation, 196105
    - Investigational Site Number 643008
  - Saint-Petersburg, Russian Federation, 194156
    - Investigational Site Number 643019
  - Samara, Russian Federation, 443070
    - Investigational Site Number 643013
  - St-Petersburg, Russian Federation, 192242
    - Investigational Site Number 643006
  - St-Petersburg, Russian Federation, 195067
    - Investigational Site Number 643025
  - St-Petersburg, Russian Federation, 197341
    - Investigational Site Number 643007
  - Tomsk, Russian Federation, 634012
    - Investigational Site Number 643012
  - Volgograd, Russian Federation, 400008
    - Investigational Site Number 643023
  - Yaroslavl, Russian Federation, 150062
    - Investigational Site Number 643017
Serbia
- - Belgrade, Serbia, 11040
    - Investigational Site Number 688505
  - Kragujevac, Serbia, 34000
    - Investigational Site Number 688501
  - Nis, Serbia, 18000
    - Investigational Site Number 688503
  - Sremska Kamenica, Serbia, 21204
    - Investigational Site Number 688502
  - Zemun, Serbia, 11080
    - Investigational Site Number 688504
  - Zemun, Serbia, 11080
    - Investigational Site Number 688506
Singapore
- - Singapore, Singapore, 168752
    - Investigational Site Number 702001
  - Singapore, Singapore, 529889
    - Investigational Site Number 702002
Slovakia
- - Banska Bystrica, Slovakia, 97401
    - Investigational Site Number 703003
  - Martin, Slovakia, 03659
    - Investigational Site Number 703002
  - Nitra, Slovakia, 950 01
    - Investigational Site Number 703001
South Africa
- - Alberton, South Africa, 1450
    - Investigational Site Number 710004
  - Cape Town, South Africa, 7500
    - Investigational Site Number 710005
  - Cape Town, South Africa, 7925
    - Investigational Site Number 710001
  - Centurion, South Africa, 181
    - Investigational Site Number 710003
  - Kuils River, South Africa, 7580
    - Investigational Site Number 710002
  - Pretoria, South Africa
    - Investigational Site Number 710007
Spain
- - Alcorcón, Spain, 28992
    - Investigational Site Number 724013
  - Alicante, Spain, 03010
    - Investigational Site Number 724001
  - Badalona, Spain, 08916
    - Investigational Site Number 724014
  - Barcelona, Spain, 08003
    - Investigational Site Number 724022
  - Barcelona, Spain, 08025
    - Investigational Site Number 724021
  - Barcelona, Spain, 08035
    - Investigational Site Number 724025
  - Barcelona, Spain, 08036
    - Investigational Site Number 724002
  - Barcelona, Spain, 08907
    - Investigational Site Number 724901
  - Cáceres, Spain, 10003
    - Investigational Site Number 724007
  - Elche, Spain, 03293
    - Investigational Site Number 724026
  - Galdakao, Spain, 48960
    - Investigational Site Number 724016
  - Girona, Spain, 17007
    - Investigational Site Number 724023
  - La Laguna, Spain, 38320
    - Investigational Site Number 724006
  - Madrid, Spain, 28035
    - Investigational Site Number 724003
  - Madrid, Spain, 28040
    - Investigational Site Number 724902
  - Madrid, Spain, 28041
    - Investigational Site Number 724027
  - Murcia, Spain, 30120
    - Investigational Site Number 724904
  - Málaga, Spain, 29010
    - Investigational Site Number 724017
  - San Juan De Alicante, Spain, 03550
    - Investigational Site Number 724018
  - Santander, Spain, 39008
    - Investigational Site Number 724005
  - Santiago De Compostela, Spain, 15706
    - Investigational Site Number 724012
  - Terrassa, Spain, 08221
    - Investigational Site Number 724903
  - Torrevieja, Spain
    - Investigational Site Number 724010
  - Valencia, Spain, 46010
    - Investigational Site Number 724024
Switzerland
- - Lugano, Switzerland, 6900
    - Investigational Site Number 756001
  - Zürich, Switzerland, 8091
    - Investigational Site Number 756002
Taiwan
- - Kaohsiung, Taiwan, 807
    - Investigational Site Number 158007
  - Kaohsiung, Taiwan, 833
    - Investigational Site Number 158002
  - Linkou, Taiwan
    - Investigational Site Number 158003
  - Taichung, Taiwan, 40447
    - Investigational Site Number 158008
  - Taipei, Taiwan, 100
    - Investigational Site Number 158904
  - Taipei, Taiwan, 104
    - Investigational Site Number 158001
  - Taipei, Taiwan, 220
    - Investigational Site Number 158009
Thailand
- - Bangkok, Thailand, 10330
    - Investigational Site Number 764002
  - Bangkok, Thailand, 10400
    - Investigational Site Number 764901
  - Bangkok, Thailand, 10700
    - Investigational Site Number 764005
  - Khon Kaen, Thailand, 40002
    - Investigational Site Number 764004
  - Klong Luang, Thailand, 12120
    - Investigational Site Number 764007
  - Muang, Thailand, 50200
    - Investigational Site Number 764903
  - Rajathavee, Thailand, 10400
    - Investigational Site Number 764006
Tunisia
- - Ariana, Tunisia, 2080
    - Investigational Site Number 788002
  - Monastir, Tunisia, 5000
    - Investigational Site Number 788005
  - Monastir, Tunisia, 5000
    - Investigational Site Number 788006
  - Tunis, Tunisia, 1008
    - Investigational Site Number 788001
  - Tunis, Tunisia, 1008
    - Investigational Site Number 788004
Turkey
- - Adana, Turkey, 01339
    - Investigational Site Number 792010
  - Ankara, Turkey, 06100
    - Investigational Site Number 792023
  - Antalya, Turkey, 07059
    - Investigational Site Number 792009
  - Bursa, Turkey, 16100
    - Investigational Site Number 792008
  - Bursa, Turkey, 16509
    - Investigational Site Number 792022
  - Edirne, Turkey, 22030
    - Investigational Site Number 792030
  - Erzurum, Turkey, 25070
    - Investigational Site Number 792006
  - Eskisehir, Turkey, 26480
    - Investigational Site Number 792020
  - Gaziantep, Turkey, 27060
    - Investigational Site Number 792004
  - Istanbul, Turkey, 34034
    - Investigational Site Number 792018
  - Istanbul, Turkey, 34093
    - Investigational Site Number 792032
  - Istanbul, Turkey, 34390
    - Investigational Site Number 792028
  - Istanbul, Turkey, 34846
    - Investigational Site Number 792016
  - Istanbul, Turkey
    - Investigational Site Number 792029
  - Izmir, Turkey, 35100
    - Investigational Site Number 792011
  - Izmir, Turkey, 35340
    - Investigational Site Number 792001
  - Izmir, Turkey, 35360
    - Investigational Site Number 792003
  - Kayseri, Turkey, 38039
    - Investigational Site Number 792012
  - Kocaeli, Turkey, 41300
    - Investigational Site Number 792014
  - Konya, Turkey, 42080
    - Investigational Site Number 792015
  - Malatya, Turkey
    - Investigational Site Number 792025
  - Mersin, Turkey, 33169
    - Investigational Site Number 792019
  - Samsun, Turkey, 55200
    - Investigational Site Number 792021
  - Sivas, Turkey, 58140
    - Investigational Site Number 792026
Ukraine
- - Cherkasy, Ukraine, 18000
    - Investigational Site Number 804004
  - Kharkiv, Ukraine, 61018
    - Investigational Site Number 804001
  - Lviv, Ukraine, 79015
    - Investigational Site Number 804005
  - Zaporozhie, Ukraine, 69600
    - Investigational Site Number 804003
United Kingdom
- - Bournemouth, United Kingdom, BH7 7DW
    - Investigational Site Number 826008
  - Bradford, United Kingdom, BD9 6RJ
    - Investigational Site Number 826007
  - Craigavon, United Kingdom, BT63 5QQ
    - Investigational Site Number 826001
  - East Kilbride, United Kingdom, G75 8RG
    - Investigational Site Number 826005
  - Hull, United Kingdom, HU16 5JQ
    - Investigational Site Number 826002
  - Manchester, United Kingdom, M13 9WL
    - Investigational Site Number 826006
  - St Leonards, United Kingdom, TN37 7RD
    - Investigational Site Number 826003
United States
- Alabama
  - Huntsville, Alabama, United States, 35801
    - Investigational Site Number 840015
- Arizona
  - Phoenix, Arizona, United States, 85008
    - Investigational Site Number 840569
  - Phoenix, Arizona, United States, 85054
    - Investigational Site Number 840703
- California
  - Anaheim, California, United States, 92801
    - Investigational Site Number 840101
  - Anaheim, California, United States, 92801
    - Investigational Site Number 840151
  - Beverley Hills, California, United States, 90211
    - Investigational Site Number 840213
  - Huntington Beach, California, United States, 92648
    - Investigational Site Number 840572
  - Long Beach, California, United States, 90806
    - Investigational Site Number 840201
  - Los Angeles, California, United States, 90024
    - Investigational Site Number 840071
  - Los Angeles, California, United States, 90024
    - Investigational Site Number 840557
  - Northridge, California, United States, 91328
    - Investigational Site Number 840903
  - San Francisco, California, United States, 94143
    - Investigational Site Number 840065
  - Santa Rosa, California, United States, 95405
    - Investigational Site Number 840561
- Colorado
  - Littleton, Colorado, United States, 80120
    - Investigational Site Number 840721
- Connecticut
  - Bridgeport, Connecticut, United States, 06606
    - Investigational Site Number 840551
  - New Haven, Connecticut, United States, 06511
    - Investigational Site Number 840166
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Investigational Site Number 840520
- Florida
  - Fort Lauderdale, Florida, United States, 33322
    - Investigational Site Number 840185
  - Jacksonville, Florida, United States, 32204
    - Investigational Site Number 840028
  - Lake Mary, Florida, United States, 32746
    - Investigational Site Number 840047
  - Melbourne, Florida, United States, 32901
    - Investigational Site Number 840500
  - Miami, Florida, United States, 33133
    - Investigational Site Number 840706
  - Ocala, Florida, United States, 34471
    - Investigational Site Number 840009
  - Ocala, Florida, United States, 34471
    - Investigational Site Number 840146
  - Orlando, Florida, United States, 32803
    - Investigational Site Number 840577
  - Sarasota, Florida, United States, 34239
    - Investigational Site Number 840021
  - St. Petersburg, Florida, United States, 33701
    - Investigational Site Number 840902
  - Tampa, Florida, United States, 33613
    - Investigational Site Number 840508
- Georgia
  - Gainesville, Georgia, United States, 30501
    - Investigational Site Number 840719
- Idaho
  - Boise, Idaho, United States, 83712
    - Investigational Site Number 840532
- Illinois
  - Aurora, Illinois, United States, 60506
    - Investigational Site Number 840105
  - Chicago, Illinois, United States, 60612
    - Investigational Site Number 840190
  - Chicago, Illinois, United States, 60637
    - Investigational Site Number 840205
  - Harvey, Illinois, United States, 60426
    - Investigational Site Number 840521
  - Joliet, Illinois, United States, 60435
    - Investigational Site Number 840148
- Indiana
  - Hammond, Indiana, United States, 46320
    - Investigational Site Number 840042
  - Indianapolis, Indiana, United States, 46202
    - Investigational Site Number 840554
  - Muncie, Indiana, United States, 47303-3400
    - Investigational Site Number 840560
- Iowa
  - Ames, Iowa, United States, 50010
    - Investigational Site Number 840904
  - West Des Moines, Iowa, United States, 50266
    - Investigational Site Number 840058
- Kansas
  - Overland, Kansas, United States, 66209
    - Investigational Site Number 840912
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Investigational Site Number 840568
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Investigational Site Number 840534
  - Lake Charles, Louisiana, United States, 70601
    - Investigational Site Number 840564
  - New Orleans, Louisiana, United States, 70112
    - Investigational Site Number 840533
- Michigan
  - Dearborn, Michigan, United States, 48123
    - Investigational Site Number 840517
  - Kalamazoo, Michigan, United States, 49007
    - Investigational Site Number 840544
  - Saginaw, Michigan, United States, 48602
    - Investigational Site Number 840531
- Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - Investigational Site Number 840525
  - Minneapolis, Minnesota, United States, 55433
    - Investigational Site Number 840510
- Mississippi
  - Tupelo, Mississippi, United States, 38801
    - Investigational Site Number 840527
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - Investigational Site Number 840208
  - Independence, Missouri, United States, 64057
    - Investigational Site Number 840209
  - Kansas City, Missouri, United States, 64108
    - Investigational Site Number 840194
  - Kansas City, Missouri, United States, 64114
    - Investigational Site Number 840138
  - Kansas City, Missouri, United States, 64128
    - Investigational Site Number 840056
  - St Louis, Missouri, United States, 63128
    - Investigational Site Number 840530
  - St Louis, Missouri, United States, 63128
    - Investigational Site Number 840580
  - St. Louis, Missouri, United States, 63128
    - Investigational Site Number 840210
  - St. Louis, Missouri, United States, 63131
    - Investigational Site Number 840052
- Montana
  - Kalispell, Montana, United States, 59901
    - Investigational Site Number 840529
- Nebraska
  - Omaha, Nebraska, United States, 68122
    - Investigational Site Number 840059
  - Omaha, Nebraska, United States, 68122
    - Investigational Site Number 840727
  - Omaha, Nebraska, United States, 68131
    - Investigational Site Number 840079
- Nevada
  - Reno, Nevada, United States, 89502
    - Investigational Site Number 840157
- New York
  - Brooklyn, New York, United States, 11215
    - Investigational Site Number 840518
  - New York, New York, United States, 10021
    - Investigational Site Number 840539
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Investigational Site Number 840585
  - Greenville, North Carolina, United States, 27834
    - Investigational Site Number 840515
  - Raleigh, North Carolina, United States, 27610
    - Investigational Site Number 840566
  - Winston Salem, North Carolina, United States, 27157-1071
    - Investigational Site Number 840908
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Investigational Site Number 840136
- Ohio
  - Toledo, Ohio, United States, 43608
    - Investigational Site Number 840082
- Oklahoma
  - Midwest City, Oklahoma, United States, 73110
    - Investigational Site Number 840025
  - Oklahoma City, Oklahoma, United States, 73112
    - Investigational Site Number 840049
  - Oklahoma City, Oklahoma, United States, 73112
    - Investigational Site Number 840905
  - Oklahoma City, Oklahoma, United States, 73135
    - Investigational Site Number 840193
  - Tulsa, Oklahoma, United States, 74104
    - Investigational Site Number 840901
- Oregon
  - Eugene, Oregon, United States, 97401
    - Investigational Site Number 840206
- Pennsylvania
  - Chambersburg, Pennsylvania, United States, 17201
    - Investigational Site Number 840540
  - Doylestown, Pennsylvania, United States, 18901
    - Investigational Site Number 840519
  - Erie, Pennsylvania, United States, 16502-4604
    - Investigational Site Number 840003
  - Harrisburg, Pennsylvania, United States, 17110
    - Investigational Site Number 840098
  - Philadelphia, Pennsylvania, United States, 19104
    - Investigational Site Number 840573
  - Pittsburgh, Pennsylvania, United States, 15224
    - Investigational Site Number 840075
  - Pittsburgh, Pennsylvania, United States, 15240
    - Investigational Site Number 840911
  - Washington, Pennsylvania, United States, 15301
    - Investigational Site Number 840211
- Tennessee
  - Oak Ridge, Tennessee, United States, 37830
    - Investigational Site Number 840072
- Texas
  - Amarillo, Texas, United States, 79106
    - Investigational Site Number 840023
  - Austin, Texas, United States, 78745
    - Investigational Site Number 840203
  - Austin, Texas, United States, 78758
    - Investigational Site Number 840574
  - Dallas, Texas, United States, 75216
    - Investigational Site Number 840060
  - Dallas, Texas, United States
    - Investigational Site Number 840578
  - Fort Worth, Texas, United States, 76104
    - Investigational Site Number 840715
  - Houston, Texas, United States, 77030
    - Investigational Site Number 840090
  - Houston, Texas, United States, 77030
    - Investigational Site Number 840207
  - Houston, Texas, United States, 77096
    - Investigational Site Number 840559
  - Houston, Texas, United States, 77096
    - Investigational Site Number 840586
  - Tyler, Texas, United States, 75701
    - Investigational Site Number 840087
  - Victoria, Texas, United States, 77901
    - Investigational Site Number 840910
  - Wichita Falls, Texas, United States, 76310
    - Investigational Site Number 840555
- Virginia
  - Richmond, Virginia, United States, 23249
    - Investigational Site Number 840553
  - Richmond, Virginia, United States, 23298
    - Investigational Site Number 840188
  - Salem, Virginia, United States, 24153
    - Investigational Site Number 840165
  - Winchester, Virginia, United States, 22601
    - Investigational Site Number 840565
- Washington
  - Tacoma, Washington, United States, 98405
    - Investigational Site Number 840121
- Wisconsin
  - Manitowoc, Wisconsin, United States, 54220
    - Investigational Site Number 840513
Vietnam
- - Hanoi, Vietnam
    - Investigational Site Number 704006
  - Ho Chi Minh City, Vietnam
    - Investigational Site Number 704001
  - Ho Chi Minh City, Vietnam
    - Investigational Site Number 704003
  - Ho Chi Minh City, Vietnam
    - Investigational Site Number 704004
  - Ho Chi Minh City, Vietnam
    - Investigational Site Number 704005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with:

Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
AND
One of the two following criteria:
- New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram,
- Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal,
AND
Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified),
AND
Informed consent obtained in writing.

Exclusion criteria:

Revascularization procedure already performed for the qualifying event Acute ST-segment elevation MI.
Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization or who have been treated by abciximab.
Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing.
Patient who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling.
Patient who cannot be treated with eptifibatide according to the national labeling (when available). In countries where eptifibatide is not approved the reference label to be considered is either the European labeling or the US labeling
Patient who cannot be treated with unfractionated heparin according to the national labeling.
Allergy to otamixaban.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: Drug C: Placebo (for Eptifibatide)	Drug: Otamixaban Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Other Names: XRP0673 Drug: Placebo (for UFH) Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Drug: Placebo (for Eptifibatide) Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Experimental: Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: Drug C: Placebo (for Eptifibatide)	Drug: Otamixaban Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Other Names: XRP0673 Drug: Placebo (for UFH) Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Drug: Placebo (for Eptifibatide) Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Active Comparator: UFH + Eptifibatide From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: Drug A: Placebo (for Otamixaban) Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)	Drug: Placebo (for Otamixaban) Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Drug: UFH Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Other Names: Unfractionated Heparin Drug: Eptifibatide Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction Time Frame: from randomization (day 1) to day 7	from randomization (day 1) to day 7
Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor) Time Frame: from day 1 to day 7	from day 1 to day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke Time Frame: from day 1 to day 7	from day 1 to day 7
Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction Time Frame: from day 1 to day 30	from day 1 to day 30
Adjudicated all-cause death Time Frame: from day 1 to day 30	from day 1 to day 30
Adjudicated Procedural thrombotic complications during the index PCI Time Frame: during index PCI	during index PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

EFC6204
2009-016568-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy

Study Overview

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What is the study measuring?

Primary Outcome Measures

Outcome Measure

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Secondary Outcome Measures

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Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on Otamixaban

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