Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation (BOREALIS-AF)

February 19, 2016 updated by: Sanofi

A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

Study Overview

Status

Terminated

Conditions

Atrial Fibrillation

Intervention / Treatment

Detailed Description

The end of the study is defined by a common study end date for all participants, defined as 9 months (39 weeks) after the last participant randomized.

All participants will receive oral warfarin (or matching placebo) and weekly SC injections of idrabiotaparinux sodium (or matching placebo) up to 6 months before the common study end date. All participants are expected to be treated for at least 6 months.

All participants will have then an 6-month observational period after cessation of study treatment.

Study Type

Interventional

Enrollment (Actual)

3773

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
- - Buenos Aires, Argentina, 1221
    - Sanofi-Aventis Investigational Site Number 032007
  - Buenos Aires, Argentina, 1416
    - Sanofi-Aventis Investigational Site Number 032011
  - Buenos Aires, Argentina, C1428AQK
    - Sanofi-Aventis Investigational Site Number 032001
  - Buenos Aires, Argentina, C1437JCP
    - Sanofi-Aventis Investigational Site Number 032005
  - Capital Federal, Argentina, C1094AAD
    - Sanofi-Aventis Investigational Site Number 032009
  - Corrientes, Argentina, 3400
    - Sanofi-Aventis Investigational Site Number 032012
  - Mar Del Plata, Argentina, 7600
    - Sanofi-Aventis Investigational Site Number 032006
  - Moron, Argentina
    - Sanofi-Aventis Investigational Site Number 032014
  - Salta, Argentina, 4400
    - Sanofi-Aventis Investigational Site Number 032016
  - Zarate, Argentina, 2800
    - Sanofi-Aventis Investigational Site Number 032010
Australia
- - Adelaide, Australia, 5035
    - Sanofi-Aventis Investigational Site Number 036006
  - Auchenflower, Australia, 4066
    - Sanofi-Aventis Investigational Site Number 036003
  - Box Hill, Australia, 3128
    - Sanofi-Aventis Investigational Site Number 036008
  - Coffs Harbour, Australia, 2450
    - Sanofi-Aventis Investigational Site Number 036005
  - Kippa Ring, Australia, 4021
    - Sanofi-Aventis Investigational Site Number 036001
  - Kippa Ring, Australia, 4021
    - Sanofi-Aventis Investigational Site Number 036002
  - Launceston, Australia, 7250
    - Sanofi-Aventis Investigational Site Number 036009
  - Woden, Australia, 2606
    - Sanofi-Aventis Investigational Site Number 036010
Austria
- - Graz, Austria, 8036
    - Sanofi-Aventis Investigational Site Number 040001
  - Linz, Austria, 4021
    - Sanofi-Aventis Investigational Site Number 040004
Belarus
- - Minsk, Belarus, 220013
    - Sanofi-Aventis Investigational Site Number 112001
  - Minsk, Belarus, 220116
    - Sanofi-Aventis Investigational Site Number 112002
  - Minsk, Belarus, 220116
    - Sanofi-Aventis Investigational Site Number 112003
  - Minsk, Belarus, 220600
    - Sanofi-Aventis Investigational Site Number 112005
Brazil
- - Belo Horizonte, Brazil, 30150-221
    - Sanofi-Aventis Investigational Site Number 076019
  - Campina Grande Do Sul, Brazil, 83430-000
    - Sanofi-Aventis Investigational Site Number 076011
  - Campinas, Brazil, 13059-740
    - Sanofi-Aventis Investigational Site Number 076007
  - Campinas, Brazil, 13083-190
    - Sanofi-Aventis Investigational Site Number 076013
  - Curitiba, Brazil, 80730-150
    - Sanofi-Aventis Investigational Site Number 076001
  - Goiania, Brazil, 74223-130
    - Sanofi-Aventis Investigational Site Number 076017
  - Goiania, Brazil, 74605-020
    - Sanofi-Aventis Investigational Site Number 076016
  - Maceio, Brazil, 57021-500
    - Sanofi-Aventis Investigational Site Number 076018
  - Porto Alegre, Brazil, 90610-000
    - Sanofi-Aventis Investigational Site Number 076012
  - Porto Alegre, Brazil, 90810-120
    - Sanofi-Aventis Investigational Site Number 076008
  - Porto Alegre, Brazil, 91350 200
    - Sanofi-Aventis Investigational Site Number 076014
  - Recife, Brazil, 52051-380
    - Sanofi-Aventis Investigational Site Number 076009
  - Sao Jose Do Rio Preto, Brazil, 15015-210
    - Sanofi-Aventis Investigational Site Number 076005
  - Sao Paulo, Brazil, 04024-002
    - Sanofi-Aventis Investigational Site Number 076010
  - Uberlandia, Brazil, 38400 299
    - Sanofi-Aventis Investigational Site Number 076015
Bulgaria
- - Pleven, Bulgaria, 5800
    - Sanofi-Aventis Investigational Site Number 100004
  - Plovdiv, Bulgaria, 4003
    - Sanofi-Aventis Investigational Site Number 100005
  - Sofia, Bulgaria, 1309
    - Sanofi-Aventis Investigational Site Number 100001
  - Sofia, Bulgaria, 1606
    - Sanofi-Aventis Investigational Site Number 100002
  - Sofia, Bulgaria, 1618
    - Sanofi-Aventis Investigational Site Number 100003
Canada
- - London, Canada, N6A 5A5
    - Sanofi-Aventis Investigational Site Number 124014
  - Newmarket, Canada, L3Y 8C3
    - Sanofi-Aventis Investigational Site Number 124006
  - Quebec, Canada, G1V 4G5
    - Sanofi-Aventis Investigational Site Number 124012
  - Toronto, Canada, M5G 2C4
    - Sanofi-Aventis Investigational Site Number 124011
Chile
- - Santiago, Chile
    - Sanofi-Aventis Investigational Site Number 152004
  - Santiago, Chile
    - Sanofi-Aventis Investigational Site Number 152005
  - Santiago, Chile, 750-0691
    - Sanofi-Aventis Investigational Site Number 152007
  - Santiago, Chile, 8053095
    - Sanofi-Aventis Investigational Site Number 152001
  - Santiago, Chile
    - Sanofi-Aventis Investigational Site Number 152003
  - Santiago, Chile
    - Sanofi-Aventis Investigational Site Number 152008
  - Viña Del Mar, Chile, 257-0017
    - Sanofi-Aventis Investigational Site Number 152009
  - Viña Del Mar, Chile
    - Sanofi-Aventis Investigational Site Number 152006
Colombia
- - Bogota, Colombia
    - Sanofi-Aventis Investigational Site Number 170003
  - Bogota, Colombia
    - Sanofi-Aventis Investigational Site Number 170006
  - Bucaramanga, Colombia
    - Sanofi-Aventis Investigational Site Number 170001
  - Envigado-Antioquia, Colombia
    - Sanofi-Aventis Investigational Site Number 170005
  - Medellin, Colombia
    - Sanofi-Aventis Investigational Site Number 170002
Costa Rica
- - San José, Costa Rica
    - Sanofi-Aventis Investigational Site Number 188004
Croatia
- - Split, Croatia, 21000
    - Sanofi-Aventis Investigational Site Number 191003
  - Zagreb, Croatia, 10000
    - Sanofi-Aventis Investigational Site Number 191001
  - Zagreb, Croatia, 10000
    - Sanofi-Aventis Investigational Site Number 191004
Czech Republic
- - Chomutov, Czech Republic, 43012
    - Sanofi-Aventis Investigational Site Number 203005
  - Jihlava, Czech Republic, 58633
    - Sanofi-Aventis Investigational Site Number 203003
  - Ostrava Vitkovice, Czech Republic, 70300
    - Sanofi-Aventis Investigational Site Number 203009
  - Pardubice, Czech Republic, 53203
    - Sanofi-Aventis Investigational Site Number 203001
  - Plzen - Bory, Czech Republic, 30599
    - Sanofi-Aventis Investigational Site Number 203011
  - Praha 2, Czech Republic, 12808
    - Sanofi-Aventis Investigational Site Number 203002
  - Praha 4, Czech Republic, 14059
    - Sanofi-Aventis Investigational Site Number 203004
  - Praha 6, Czech Republic, 16902
    - Sanofi-Aventis Investigational Site Number 203010
  - Prostejov, Czech Republic, 796 04
    - Sanofi-Aventis Investigational Site Number 203006
  - Usti Nad Orlici, Czech Republic, 56218
    - Sanofi-Aventis Investigational Site Number 203008
Denmark
- - Glostrup, Denmark, 2600
    - Sanofi-Aventis Investigational Site Number 208002
  - Hellerup, Denmark, 2900
    - Sanofi-Aventis Investigational Site Number 208001
  - Hvidovre, Denmark, 2650
    - Sanofi-Aventis Investigational Site Number 208007
  - København S, Denmark, 2300
    - Sanofi-Aventis Investigational Site Number 208003
  - Odense, Denmark, 5000
    - Sanofi-Aventis Investigational Site Number 208004
  - Roskilde, Denmark, 4000
    - Sanofi-Aventis Investigational Site Number 208006
  - Svendborg, Denmark, 5700
    - Sanofi-Aventis Investigational Site Number 208005
Egypt
- - Alexandria, Egypt
    - Sanofi-Aventis Investigational Site Number 818002
  - Alexandria, Egypt
    - Sanofi-Aventis Investigational Site Number 818003
  - Alexandria, Egypt
    - Sanofi-Aventis Investigational Site Number 818004
  - Cairo, Egypt
    - Sanofi-Aventis Investigational Site Number 818001
Estonia
- - Tallinn, Estonia, 10138
    - Sanofi-Aventis Investigational Site Number 233003
  - Tallinn, Estonia, 13415
    - Sanofi-Aventis Investigational Site Number 233004
  - Tallinn, Estonia, 13419
    - Sanofi-Aventis Investigational Site Number 233001
  - Tartu, Estonia, 50410
    - Sanofi-Aventis Investigational Site Number 233002
Finland
- - Helsinki, Finland, 00290
    - Sanofi-Aventis Investigational Site Number 246001
France
- - Abbeville, France, 80142
    - Sanofi-Aventis Investigational Site Number 250028
  - Albi Cedex 9, France, 81013
    - Sanofi-Aventis Investigational Site Number 250012
  - Allauch, France, 13190
    - Sanofi-Aventis Investigational Site Number 250034
  - Belfort Cedex, France, 90016
    - Sanofi-Aventis Investigational Site Number 250031
  - Bordeaux, France, 33076
    - Sanofi-Aventis Investigational Site Number 250011
  - Brest, France, 29609
    - Sanofi-Aventis Investigational Site Number 250021
  - Brest Cedex 2, France, 29609
    - Sanofi-Aventis Investigational Site Number 250010
  - Bron, France, 69677
    - Sanofi-Aventis Investigational Site Number 250035
  - Cholet Cedex, France, 49300
    - Sanofi-Aventis Investigational Site Number 250022
  - Dijon, France, 21033
    - Sanofi-Aventis Investigational Site Number 250006
  - Dijon Cedex, France, 21034
    - Sanofi-Aventis Investigational Site Number 250018
  - La Rochelle, France, 17019
    - Sanofi-Aventis Investigational Site Number 250004
  - Le Chesnay Cedex, France, 78187
    - Sanofi-Aventis Investigational Site Number 250029
  - Lille, France, 59020
    - Sanofi-Aventis Investigational Site Number 250019
  - Lille, France, 59037
    - Sanofi-Aventis Investigational Site Number 250015
  - Metz Tessy, France, 74370
    - Sanofi-Aventis Investigational Site Number 250030
  - Montpellier, France, 34295
    - Sanofi-Aventis Investigational Site Number 250003
  - Montpellier, France, 59523
    - Sanofi-Aventis Investigational Site Number 250032
  - Nice Cedex, France, 06006
    - Sanofi-Aventis Investigational Site Number 250016
  - Paris, France, 75018
    - Sanofi-Aventis Investigational Site Number 250001
  - Paris Cedex 13, France, 75651
    - Sanofi-Aventis Investigational Site Number 250014
  - Paris Cedex 14, France, 75674
    - Sanofi-Aventis Investigational Site Number 250008
  - Saint Etienne Cedex 2, France, 42055
    - Sanofi-Aventis Investigational Site Number 250005
  - Toulouse Cedex 9, France, 31059
    - Sanofi-Aventis Investigational Site Number 250026
  - Tours Cedex 1, France, 37044
    - Sanofi-Aventis Investigational Site Number 250027
  - Vandoeuvre Les Nancy Cedex, France, 54511
    - Sanofi-Aventis Investigational Site Number 250002
Greece
- - Athens, Greece, 11521
    - Sanofi-Aventis Investigational Site Number 300009
  - Athens, Greece, 11527
    - Sanofi-Aventis Investigational Site Number 300007
  - Athens, Greece, 11538
    - Sanofi-Aventis Investigational Site Number 300002
  - Athens, Greece
    - Sanofi-Aventis Investigational Site Number 300005
  - Chalkida, Greece, 34 100
    - Sanofi-Aventis Investigational Site Number 300006
  - Chios, Greece
    - Sanofi-Aventis Investigational Site Number 300004
  - Elefsina, Greece, 19600
    - Sanofi-Aventis Investigational Site Number 300008
Guatemala
- - Guatemala, Guatemala, 01010
    - Sanofi-Aventis Investigational Site Number 320002
  - Guatemala, Guatemala, 01014
    - Sanofi-Aventis Investigational Site Number 320001
  - Guatemala, Guatemala, 01014
    - Sanofi-Aventis Investigational Site Number 320003
  - Guatemala, Guatemala
    - Sanofi-Aventis Investigational Site Number 320004
India
- - Ahmedabad, India, 380 015
    - Sanofi-Aventis Investigational Site Number 356001
  - Ahmedabad, India, 380054
    - Sanofi-Aventis Investigational Site Number 356010
  - Bangalore, India, 560034
    - Sanofi-Aventis Investigational Site Number 356015
  - Bangalore, India, 562 150
    - Sanofi-Aventis Investigational Site Number 356009
  - Chennai, India, 600 037
    - Sanofi-Aventis Investigational Site Number 356005
  - Coimbatore, India, 641004
    - Sanofi-Aventis Investigational Site Number 356002
  - Coimbatore, India, 641014
    - Sanofi-Aventis Investigational Site Number 356007
  - Lucknow, India, 226003
    - Sanofi-Aventis Investigational Site Number 356013
  - Lucknow, India, 226014
    - Sanofi-Aventis Investigational Site Number 356006
  - Mumbai, India, 54
    - Sanofi-Aventis Investigational Site Number 356017
  - Mysore, India, 570020
    - Sanofi-Aventis Investigational Site Number 356014
  - Nashik, India, 42003
    - Sanofi-Aventis Investigational Site Number 356020
  - New Delhi, India, 110060
    - Sanofi-Aventis Investigational Site Number 356004
  - New Delhi, India
    - Sanofi-Aventis Investigational Site Number 356012
  - Pune, India, 411004
    - Sanofi-Aventis Investigational Site Number 356011
  - Pune., India, 400011
    - Sanofi-Aventis Investigational Site Number 356018
  - Secunderabad, India, 500 003
    - Sanofi-Aventis Investigational Site Number 356003
Indonesia
- - Jakarta, Indonesia, 10430
    - Sanofi-Aventis Investigational Site Number 360002
  - Jakarta, Indonesia
    - Sanofi-Aventis Investigational Site Number 360001
Israel
- - Afula, Israel, 18101
    - Sanofi-Aventis Investigational Site Number 376003
  - Ashkelon, Israel, 78278
    - Sanofi-Aventis Investigational Site Number 376015
  - Givatayim, Israel, 53583
    - Sanofi-Aventis Investigational Site Number 376001
  - Haifa, Israel, 31048
    - Sanofi-Aventis Investigational Site Number 376007
  - Haifa, Israel, 31096
    - Sanofi-Aventis Investigational Site Number 376014
  - Holon, Israel, 58100
    - Sanofi-Aventis Investigational Site Number 376004
  - Nahariya, Israel, 22100
    - Sanofi-Aventis Investigational Site Number 376012
  - Nazareth, Israel, 16100
    - Sanofi-Aventis Investigational Site Number 376009
  - Rehovot, Israel, 76100
    - Sanofi-Aventis Investigational Site Number 376011
  - Tel Aviv, Israel, 64239
    - Sanofi-Aventis Investigational Site Number 376002
Italy
- - Ascoli Piceno, Italy, 63100
    - Sanofi-Aventis Investigational Site Number 380015
  - Borgo San Lorenzo, Italy, 50032
    - Sanofi-Aventis Investigational Site Number 380018
  - Chieti, Italy, 66013
    - Sanofi-Aventis Investigational Site Number 380016
  - Fidenza, Italy, 43036
    - Sanofi-Aventis Investigational Site Number 380005
  - Merate, Italy, 23807
    - Sanofi-Aventis Investigational Site Number 380010
  - Milano, Italy, 20132
    - Sanofi-Aventis Investigational Site Number 380014
  - Novara, Italy, 28100
    - Sanofi-Aventis Investigational Site Number 380020
  - Padova, Italy, 35128
    - Sanofi-Aventis Investigational Site Number 380001
  - Padova, Italy, 35128
    - Sanofi-Aventis Investigational Site Number 380007
  - Palermo, Italy, 90127
    - Sanofi-Aventis Investigational Site Number 380004
  - Pavia, Italy, 27100
    - Sanofi-Aventis Investigational Site Number 380008
  - Perugia, Italy, 06132
    - Sanofi-Aventis Investigational Site Number 380021
  - San Daniele Del Friuli, Italy, 33038
    - Sanofi-Aventis Investigational Site Number 380013
  - Sassari, Italy, 07100
    - Sanofi-Aventis Investigational Site Number 380003
  - Torino, Italy, 10144
    - Sanofi-Aventis Investigational Site Number 380011
  - Treviso, Italy, 31100
    - Sanofi-Aventis Investigational Site Number 380009
Korea, Republic of
- - Anyang, Korea, Republic of, 431-070
    - Sanofi-Aventis Investigational Site Number 410008
  - Daegu, Korea, Republic of, 700-712
    - Sanofi-Aventis Investigational Site Number 410002
  - Goyang, Korea, Republic of, 411-706
    - Sanofi-Aventis Investigational Site Number 410006
  - Goyang, Korea, Republic of, 411-773
    - Sanofi-Aventis Investigational Site Number 410012
  - Gwangju, Korea, Republic of, 501-757
    - Sanofi-Aventis Investigational Site Number 410007
  - Seongnam, Korea, Republic of, 463-802
    - Sanofi-Aventis Investigational Site Number 410003
  - Seoul, Korea, Republic of, 134-701
    - Sanofi-Aventis Investigational Site Number 410001
  - Seoul, Korea, Republic of, 135-710
    - Sanofi-Aventis Investigational Site Number 410004
  - Seoul, Korea, Republic of, 138-736
    - Sanofi-Aventis Investigational Site Number 410005
  - Seoul, Korea, Republic of, 140-210
    - Sanofi-Aventis Investigational Site Number 410011
Lithuania
- - Kaunas, Lithuania, 3007
    - Sanofi-Aventis Investigational Site Number 440004
  - Kaunas, Lithuania, LT-49456
    - Sanofi-Aventis Investigational Site Number 440002
  - Vilnius, Lithuania, LT-07156
    - Sanofi-Aventis Investigational Site Number 440003
  - Vilnius, Lithuania, LT-08661
    - Sanofi-Aventis Investigational Site Number 440001
Malaysia
- - Kuching, Malaysia, 93586
    - Sanofi-Aventis Investigational Site Number 458001
  - Penang, Malaysia, 10450
    - Sanofi-Aventis Investigational Site Number 458002
  - Taiping, Malaysia, 34000
    - Sanofi-Aventis Investigational Site Number 458005
Mexico
- - Acapulco, Mexico, 39670
    - Sanofi-Aventis Investigational Site Number 484008
  - Aguascalientes, Mexico, 20230
    - Sanofi-Aventis Investigational Site Number 484013
  - Aguascalientes, Mexico, 20230
    - Sanofi-Aventis Investigational Site Number 484016
  - Guadalajara, Mexico, 4428
    - Sanofi-Aventis Investigational Site Number 484004
  - Guadalajara, Mexico, 44340
    - Sanofi-Aventis Investigational Site Number 484007
  - Mexico Df, Mexico, 07300
    - Sanofi-Aventis Investigational Site Number 484012
  - Monterrey, Mexico, 64060
    - Sanofi-Aventis Investigational Site Number 484010
  - San Luis Potosi, Mexico, 72244
    - Sanofi-Aventis Investigational Site Number 484011
  - San Luis Potosi, Mexico, 78200
    - Sanofi-Aventis Investigational Site Number 484005
  - Veracruz, Mexico, 91700
    - Sanofi-Aventis Investigational Site Number 484003
Morocco
- - Marrakech, Morocco, 40000
    - Sanofi-Aventis Investigational Site Number 504001
  - Meknes, Morocco, 50000
    - Sanofi-Aventis Investigational Site Number 504002
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Sanofi-Aventis Investigational Site Number 528012
  - Amsterdam, Netherlands, 1066 EC
    - Sanofi-Aventis Investigational Site Number 528030
  - Breda, Netherlands, 4818 CK
    - Sanofi-Aventis Investigational Site Number 528026
  - Delft, Netherlands, 2526 AD
    - Sanofi-Aventis Investigational Site Number 528009
  - Den Haag, Netherlands, 2545 CH
    - Sanofi-Aventis Investigational Site Number 528035
  - Ede, Netherlands, 6716 RP
    - Sanofi-Aventis Investigational Site Number 528027
  - Eindhoven, Netherlands, 5623 EJ
    - Sanofi-Aventis Investigational Site Number 528006
  - Eindhoven, Netherlands, 5623 EJ
    - Sanofi-Aventis Investigational Site Number 528017
  - Gouda, Netherlands, 2803 HH
    - Sanofi-Aventis Investigational Site Number 528016
  - Harderwijk, Netherlands, 3844 DG
    - Sanofi-Aventis Investigational Site Number 528007
  - Heerlen, Netherlands, 6419 PC
    - Sanofi-Aventis Investigational Site Number 528001
  - Heerlen, Netherlands, 6419 PC
    - Sanofi-Aventis Investigational Site Number 528024
  - Hengelo, Netherlands, 7555 DL
    - Sanofi-Aventis Investigational Site Number 528003
  - Hengelo, Netherlands, 7555 DL
    - Sanofi-Aventis Investigational Site Number 528010
  - Hoogeveen, Netherlands, 7909 AA
    - Sanofi-Aventis Investigational Site Number 528031
  - Hoorn, Netherlands, 1625 HV
    - Sanofi-Aventis Investigational Site Number 528019
  - Leeuwarden, Netherlands, 8934 AD
    - Sanofi-Aventis Investigational Site Number 528020
  - Nijmegen, Netherlands, 6532 SZ
    - Sanofi-Aventis Investigational Site Number 528004
  - Rotterdam, Netherlands, 3083 AN
    - Sanofi-Aventis Investigational Site Number 528013
  - Sittard-Geleen, Netherlands, 6162 BG
    - Sanofi-Aventis Investigational Site Number 528022
  - Sneek, Netherlands, 8601 ZK
    - Sanofi-Aventis Investigational Site Number 528002
  - Tilburg, Netherlands, 5022 GC
    - Sanofi-Aventis Investigational Site Number 528033
  - Venlo, Netherlands, 5912 BL
    - Sanofi-Aventis Investigational Site Number 528021
  - Zoetermeer, Netherlands, 2725 NA
    - Sanofi-Aventis Investigational Site Number 528005
  - Zwolle, Netherlands, 8011 JW
    - Sanofi-Aventis Investigational Site Number 528025
New Zealand
- - Christchurch, New Zealand
    - Sanofi-Aventis Investigational Site Number 554003
  - Dunedin, New Zealand
    - Sanofi-Aventis Investigational Site Number 554002
  - Nelson, New Zealand
    - Sanofi-Aventis Investigational Site Number 554001
Norway
- - Bergen, Norway, 5021
    - Sanofi-Aventis Investigational Site Number 578001
  - Flekkefjord, Norway, 4400
    - Sanofi-Aventis Investigational Site Number 578006
  - Lørenskog, Norway, 1478
    - Sanofi-Aventis Investigational Site Number 578005
  - Oslo, Norway, 0027
    - Sanofi-Aventis Investigational Site Number 578004
Panama
- - Panama, Panama
    - Sanofi-Aventis Investigational Site Number 591001
  - Panama, Panama
    - Sanofi-Aventis Investigational Site Number 591002
  - Panama, Panama
    - Sanofi-Aventis Investigational Site Number 591003
Peru
- - Lima, Peru, CALLAO 2
    - Sanofi-Aventis Investigational Site Number 604004
  - Lima, Peru, Lima 11
    - Sanofi-Aventis Investigational Site Number 604002
  - Lima, Peru, LIMA 13
    - Sanofi-Aventis Investigational Site Number 604001
  - Lima, Peru, LIMA 31
    - Sanofi-Aventis Investigational Site Number 604005
  - Lima, Peru, LIMA 41
    - Sanofi-Aventis Investigational Site Number 604003
Philippines
- - Quezon City, Philippines, 1102
    - Sanofi-Aventis Investigational Site Number 608001
Poland
- - Chojnice, Poland, 89-600
    - Sanofi-Aventis Investigational Site Number 616013
  - Gdansk, Poland, 81-756
    - Sanofi-Aventis Investigational Site Number 616011
  - Gdynia-Redlowo, Poland, 81-402
    - Sanofi-Aventis Investigational Site Number 616014
  - Katowice, Poland, 40-635
    - Sanofi-Aventis Investigational Site Number 616009
  - Lodz, Poland, 91-425
    - Sanofi-Aventis Investigational Site Number 616017
  - Lublin, Poland, 20-954
    - Sanofi-Aventis Investigational Site Number 616002
  - Ostrowiec Swietokrzyski, Poland, 27-400
    - Sanofi-Aventis Investigational Site Number 616012
  - Pulawy, Poland, 24-100
    - Sanofi-Aventis Investigational Site Number 616015
  - Torun, Poland, 87-100
    - Sanofi-Aventis Investigational Site Number 616007
  - Tychy, Poland, 43-100
    - Sanofi-Aventis Investigational Site Number 616006
  - Warszawa, Poland, 02-005
    - Sanofi-Aventis Investigational Site Number 616001
  - Warszawa, Poland, 02-097
    - Sanofi-Aventis Investigational Site Number 616010
  - Wroclaw, Poland, 50-349
    - Sanofi-Aventis Investigational Site Number 616008
Portugal
- - Amadora, Portugal, 2720-276
    - Sanofi-Aventis Investigational Site Number 620002
  - Braga, Portugal, 4701-968
    - Sanofi-Aventis Investigational Site Number 620007
  - Coimbra, Portugal, 3000-075
    - Sanofi-Aventis Investigational Site Number 620006
  - Setubal, Portugal, 2910-446
    - Sanofi-Aventis Investigational Site Number 620008
Puerto Rico
- - San Juan, Puerto Rico, 00921-3201
    - Sanofi-Aventis Investigational Site Number 630001
Russian Federation
- - Barnaul, Russian Federation, 656055
    - Sanofi-Aventis Investigational Site Number 643033
  - Chelyabinsk, Russian Federation, 454048
    - Sanofi-Aventis Investigational Site Number 643040
  - Chelyabinsk, Russian Federation, 454092
    - Sanofi-Aventis Investigational Site Number 643050
  - Chelyabinsk, Russian Federation, 454136
    - Sanofi-Aventis Investigational Site Number 643036
  - Ekaterinburg, Russian Federation, 620109
    - Sanofi-Aventis Investigational Site Number 643031
  - Kemerovo, Russian Federation, 650002
    - Sanofi-Aventis Investigational Site Number 643009
  - Kemerovo, Russian Federation, 650002
    - Sanofi-Aventis Investigational Site Number 643042
  - Moscow, Russian Federation, 105066
    - Sanofi-Aventis Investigational Site Number 643015
  - Moscow, Russian Federation, 109263
    - Sanofi-Aventis Investigational Site Number 643032
  - Moscow, Russian Federation, 111539
    - Sanofi-Aventis Investigational Site Number 643007
  - Moscow, Russian Federation, 117292
    - Sanofi-Aventis Investigational Site Number 643020
  - Moscow, Russian Federation, 117342
    - Sanofi-Aventis Investigational Site Number 643054
  - Moscow, Russian Federation, 117556
    - Sanofi-Aventis Investigational Site Number 643052
  - Moscow, Russian Federation, 119415
    - Sanofi-Aventis Investigational Site Number 643056
  - Moscow, Russian Federation, 119435
    - Sanofi-Aventis Investigational Site Number 643025
  - Moscow, Russian Federation, 119435
    - Sanofi-Aventis Investigational Site Number 643053
  - Moscow, Russian Federation, 121359
    - Sanofi-Aventis Investigational Site Number 643028
  - Moscow, Russian Federation, 121359
    - Sanofi-Aventis Investigational Site Number 643037
  - Moscow, Russian Federation, 121552
    - Sanofi-Aventis Investigational Site Number 643001
  - Moscow, Russian Federation, 121552
    - Sanofi-Aventis Investigational Site Number 643026
  - Moscow, Russian Federation, 121552
    - Sanofi-Aventis Investigational Site Number 643039
  - Moscow, Russian Federation, 127473
    - Sanofi-Aventis Investigational Site Number 643011
  - Moscow, Russian Federation, 127473
    - Sanofi-Aventis Investigational Site Number 643034
  - Moscow, Russian Federation, 129090
    - Sanofi-Aventis Investigational Site Number 643049
  - Moscow, Russian Federation, 129336
    - Sanofi-Aventis Investigational Site Number 643030
  - Nizhny Novgorod, Russian Federation, 603003
    - Sanofi-Aventis Investigational Site Number 643013
  - Nizniy Novgorod, Russian Federation, 603005
    - Sanofi-Aventis Investigational Site Number 643041
  - Novosibirsk, Russian Federation, 630008
    - Sanofi-Aventis Investigational Site Number 643051
  - Novosibirsk, Russian Federation, 630091
    - Sanofi-Aventis Investigational Site Number 643044
  - Novosibirsk-117, Russian Federation, 630117
    - Sanofi-Aventis Investigational Site Number 643048
  - Penza, Russian Federation
    - Sanofi-Aventis Investigational Site Number 643045
  - Perm, Russian Federation, 614097
    - Sanofi-Aventis Investigational Site Number 643023
  - Perm, Russian Federation, 614107
    - Sanofi-Aventis Investigational Site Number 643006
  - Petrozavodsk, Russian Federation, 185019
    - Sanofi-Aventis Investigational Site Number 643046
  - Rostov-Na-Donu, Russian Federation, 344068
    - Sanofi-Aventis Investigational Site Number 643012
  - Ryazan, Russian Federation, 390026
    - Sanofi-Aventis Investigational Site Number 643008
  - Saint-Petersburg, Russian Federation, 197022
    - Sanofi-Aventis Investigational Site Number 643017
  - Saint-Petersburg, Russian Federation, 197022
    - Sanofi-Aventis Investigational Site Number 643047
  - Samara, Russian Federation, 443070
    - Sanofi-Aventis Investigational Site Number 643029
  - Saratov, Russian Federation, 410028
    - Sanofi-Aventis Investigational Site Number 643004
  - Saratov, Russian Federation, 410028
    - Sanofi-Aventis Investigational Site Number 643005
  - Saratov, Russian Federation, 410054
    - Sanofi-Aventis Investigational Site Number 643003
  - St-Petersburg, Russian Federation, 192242
    - Sanofi-Aventis Investigational Site Number 643022
  - St-Petersburg, Russian Federation, 194354
    - Sanofi-Aventis Investigational Site Number 643038
  - St-Petersburg, Russian Federation, 196247
    - Sanofi-Aventis Investigational Site Number 643016
  - St-Petersburg, Russian Federation, 197110
    - Sanofi-Aventis Investigational Site Number 643018
  - St-Petersburg, Russian Federation, 198013
    - Sanofi-Aventis Investigational Site Number 643010
  - St-Petersburg, Russian Federation, 198013
    - Sanofi-Aventis Investigational Site Number 643027
  - St-Petersburg, Russian Federation, 199106
    - Sanofi-Aventis Investigational Site Number 643002
  - Tomsk, Russian Federation, 634012
    - Sanofi-Aventis Investigational Site Number 643024
  - Tomsk, Russian Federation, 634012
    - Sanofi-Aventis Investigational Site Number 643035
  - Tyumen, Russian Federation, 625023
    - Sanofi-Aventis Investigational Site Number 643021
  - Voronezh, Russian Federation, 394006
    - Sanofi-Aventis Investigational Site Number 643043
  - Yaroslavl, Russian Federation, 150062
    - Sanofi-Aventis Investigational Site Number 643019
Slovakia
- - Kosice, Slovakia, 04015
    - Sanofi-Aventis Investigational Site Number 703003
  - Levice, Slovakia
    - Sanofi-Aventis Investigational Site Number 703005
  - Nitra, Slovakia, 950 01
    - Sanofi-Aventis Investigational Site Number 703004
  - Poprad, Slovakia, 05845
    - Sanofi-Aventis Investigational Site Number 703006
  - Trnava, Slovakia, 91775
    - Sanofi-Aventis Investigational Site Number 703002
South Africa
- - Amanzimtoti, South Africa
    - Sanofi-Aventis Investigational Site Number 710013
  - Bloemfontein, South Africa
    - Sanofi-Aventis Investigational Site Number 710011
  - Cape Town, South Africa, 7129
    - Sanofi-Aventis Investigational Site Number 710007
  - Cape Town, South Africa, 7764
    - Sanofi-Aventis Investigational Site Number 710017
  - Durban, South Africa, 4092
    - Sanofi-Aventis Investigational Site Number 710001
  - Durban, South Africa
    - Sanofi-Aventis Investigational Site Number 710012
  - Johannesburg, South Africa, 1449
    - Sanofi-Aventis Investigational Site Number 710009
  - Port Elizabeth, South Africa
    - Sanofi-Aventis Investigational Site Number 710016
  - Pretoria, South Africa, 0084
    - Sanofi-Aventis Investigational Site Number 710003
  - Pretoria, South Africa, 0050
    - Sanofi-Aventis Investigational Site Number 710020
  - Pretoria, South Africa, 0204
    - Sanofi-Aventis Investigational Site Number 710002
  - Randburg, South Africa, 2194
    - Sanofi-Aventis Investigational Site Number 710015
  - Scottburgh, South Africa
    - Sanofi-Aventis Investigational Site Number 710014
  - Umhlanga Rocks, South Africa, 4400
    - Sanofi-Aventis Investigational Site Number 710018
Spain
- - Barcelona, Spain, 08003
    - Sanofi-Aventis Investigational Site Number 724003
  - Barcelona, Spain, 08036
    - Sanofi-Aventis Investigational Site Number 724002
  - Madrid, Spain, 28046
    - Sanofi-Aventis Investigational Site Number 724001
  - Santiago De Compostela, Spain, 15706
    - Sanofi-Aventis Investigational Site Number 724005
  - Sevilla, Spain, 41006
    - Sanofi-Aventis Investigational Site Number 724007
Sweden
- - Göteborg, Sweden, 413 45
    - Sanofi-Aventis Investigational Site Number 752003
  - Göteborg, Sweden, 413 45
    - Sanofi-Aventis Investigational Site Number 752006
  - Malmo, Sweden, 211 52
    - Sanofi-Aventis Investigational Site Number 752007
  - Malmö, Sweden, 20502
    - Sanofi-Aventis Investigational Site Number 752002
  - Ostersund, Sweden, 831 83
    - Sanofi-Aventis Investigational Site Number 752004
  - Stockolm, Sweden, SE-171 76
    - Sanofi-Aventis Investigational Site Number 752001
Taiwan
- - Kaohsiung, Taiwan, 833
    - Sanofi-Aventis Investigational Site Number 158003
  - Taichung, Taiwan
    - Sanofi-Aventis Investigational Site Number 158002
  - Tainan Hsien, Taiwan, 710
    - Sanofi-Aventis Investigational Site Number 158004
  - Taipei, Taiwan
    - Sanofi-Aventis Investigational Site Number 158001
  - Taipei, Taiwan
    - Sanofi-Aventis Investigational Site Number 158005
Thailand
- - Bangkok, Thailand, 10330
    - Sanofi-Aventis Investigational Site Number 764001
  - Bangkok-Noi, Thailand, 10700
    - Sanofi-Aventis Investigational Site Number 764002
  - Muang, Thailand, 50200
    - Sanofi-Aventis Investigational Site Number 764003
Turkey
- - Edirne, Turkey
    - Sanofi-Aventis Investigational Site Number 792004
  - Edirne, Turkey
    - Sanofi-Aventis Investigational Site Number 792005
  - Istanbul, Turkey, 34034
    - Sanofi-Aventis Investigational Site Number 792002
  - Istanbul, Turkey
    - Sanofi-Aventis Investigational Site Number 792001
  - Istanbul, Turkey
    - Sanofi-Aventis Investigational Site Number 792003
  - Kocaeli, Turkey, 41300
    - Sanofi-Aventis Investigational Site Number 792006
  - Kocaeli, Turkey, 41380
    - Sanofi-Aventis Investigational Site Number 792007
Ukraine
- - Dnepropetrovsk, Ukraine
    - Sanofi-Aventis Investigational Site Number 804013
  - Dnepropetrovsk, Ukraine
    - Sanofi-Aventis Investigational Site Number 804015
  - Dnipropetrovsk, Ukraine
    - Sanofi-Aventis Investigational Site Number 804005
  - Ivano-Frankivsk, Ukraine
    - Sanofi-Aventis Investigational Site Number 804008
  - Kharkiv, Ukraine
    - Sanofi-Aventis Investigational Site Number 804004
  - Kharkov, Ukraine
    - Sanofi-Aventis Investigational Site Number 804002
  - Kharkov, Ukraine
    - Sanofi-Aventis Investigational Site Number 804012
  - Kiev, Ukraine
    - Sanofi-Aventis Investigational Site Number 804003
  - Lutsk, Ukraine
    - Sanofi-Aventis Investigational Site Number 804007
  - Lutsk, Ukraine
    - Sanofi-Aventis Investigational Site Number 804009
  - Odessa, Ukraine
    - Sanofi-Aventis Investigational Site Number 804011
  - Ternopil, Ukraine
    - Sanofi-Aventis Investigational Site Number 804010
  - Uzhgorod, Ukraine
    - Sanofi-Aventis Investigational Site Number 804006
  - Zaporizhzhia, Ukraine
    - Sanofi-Aventis Investigational Site Number 804014
United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Sanofi-Aventis Investigational Site Number 840227
- Arizona
  - Tucson, Arizona, United States, 85723
    - Sanofi-Aventis Investigational Site Number 840209
- Arkansas
  - Little Rock, Arkansas, United States, 72204
    - Sanofi-Aventis Investigational Site Number 840255
  - Little Rock, Arkansas, United States, 72205
    - Sanofi-Aventis Investigational Site Number 840224
  - Mountain Home, Arkansas, United States, 72653
    - Sanofi-Aventis Investigational Site Number 840179
- California
  - Beverly Hills, California, United States, 90210
    - Sanofi-Aventis Investigational Site Number 840270
  - Beverly Hills, California, United States, 90211
    - Sanofi-Aventis Investigational Site Number 840278
  - Burbank, California, United States, 91505
    - Sanofi-Aventis Investigational Site Number 840241
  - Corona, California, United States, 92879
    - Sanofi-Aventis Investigational Site Number 840010
  - Encino, California, United States, 91436
    - Sanofi-Aventis Investigational Site Number 840195
  - Loma Linda, California, United States, 92354
    - Sanofi-Aventis Investigational Site Number 840033
  - Long Beach, California, United States, 90813
    - Sanofi-Aventis Investigational Site Number 840184
  - Los Banos, California, United States, 93635
    - Sanofi-Aventis Investigational Site Number 840183
  - Northridge, California, United States, 91325
    - Sanofi-Aventis Investigational Site Number 840272
  - Orange, California, United States, 92868
    - Sanofi-Aventis Investigational Site Number 840213
  - Redondo Beach, California, United States, 90277
    - Sanofi-Aventis Investigational Site Number 840009
  - Riverside, California, United States, 92501
    - Sanofi-Aventis Investigational Site Number 840298
  - San Diego, California, United States, 92103
    - Sanofi-Aventis Investigational Site Number 840264
  - San Diego, California, United States, 92128
    - Sanofi-Aventis Investigational Site Number 840275
  - Santa Ana, California, United States, 92704
    - Sanofi-Aventis Investigational Site Number 840103
  - Santa Rosa, California, United States, 95405
    - Sanofi-Aventis Investigational Site Number 840002
  - Torrance, California, United States, 90505
    - Sanofi-Aventis Investigational Site Number 840111
  - Visalia, California, United States, 93291
    - Sanofi-Aventis Investigational Site Number 840118
- Connecticut
  - Bridgeport, Connecticut, United States, 06610
    - Sanofi-Aventis Investigational Site Number 840268
- Florida
  - Bay Pines, Florida, United States, 33744
    - Sanofi-Aventis Investigational Site Number 840246
  - Beach, Florida, United States, 32168
    - Sanofi-Aventis Investigational Site Number 840066
  - Brandon, Florida, United States, 33511
    - Sanofi-Aventis Investigational Site Number 840313
  - Dunnellon, Florida, United States, 34432
    - Sanofi-Aventis Investigational Site Number 840084
  - Fort Lauderdale, Florida, United States, 33316
    - Sanofi-Aventis Investigational Site Number 840220
  - Ft. Lauderdale, Florida, United States, 33308
    - Sanofi-Aventis Investigational Site Number 840138
  - Gainesville, Florida, United States, 32608
    - Sanofi-Aventis Investigational Site Number 840215
  - Hollywood, Florida, United States, 33021
    - Sanofi-Aventis Investigational Site Number 840131
  - Hollywood, Florida, United States, 33021
    - Sanofi-Aventis Investigational Site Number 840161
  - Key West, Florida, United States, 33040
    - Sanofi-Aventis Investigational Site Number 840234
  - Lake Mary, Florida, United States, 32746
    - Sanofi-Aventis Investigational Site Number 840112
  - Lakeland, Florida, United States, 33805
    - Sanofi-Aventis Investigational Site Number 840053
  - Melbourne, Florida, United States, 32901
    - Sanofi-Aventis Investigational Site Number 840198
  - Miami, Florida, United States, 33156
    - Sanofi-Aventis Investigational Site Number 840117
  - Niceville, Florida, United States, 32578
    - Sanofi-Aventis Investigational Site Number 840003
  - Ocala, Florida, United States, 34471
    - Sanofi-Aventis Investigational Site Number 840230
  - Orlando, Florida, United States, 32803
    - Sanofi-Aventis Investigational Site Number 840202
  - Orlando, Florida, United States, 32822
    - Sanofi-Aventis Investigational Site Number 840306
  - Ormond Beach, Florida, United States, 32174
    - Sanofi-Aventis Investigational Site Number 840022
  - Palm Harbor, Florida, United States, 34684
    - Sanofi-Aventis Investigational Site Number 840110
  - Plantation, Florida, United States, 33317
    - Sanofi-Aventis Investigational Site Number 840211
  - Sanford, Florida, United States, 32271
    - Sanofi-Aventis Investigational Site Number 840116
  - Spring Hill, Florida, United States, 34609
    - Sanofi-Aventis Investigational Site Number 840243
  - St. Petersburg, Florida, United States, 33701
    - Sanofi-Aventis Investigational Site Number 840082
  - St. Petersburg, Florida, United States, 33707
    - Sanofi-Aventis Investigational Site Number 840012
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Sanofi-Aventis Investigational Site Number 840073
  - Augusta, Georgia, United States, 30909
    - Sanofi-Aventis Investigational Site Number 840273
  - Columbus, Georgia, United States, 31904-5245
    - Sanofi-Aventis Investigational Site Number 840204
  - Columbus, Georgia, United States, 31904
    - Sanofi-Aventis Investigational Site Number 840290
  - Columbus, Georgia, United States, 31907
    - Sanofi-Aventis Investigational Site Number 840225
  - Dunwoody, Georgia, United States, 30338
    - Sanofi-Aventis Investigational Site Number 840305
  - Savannah, Georgia, United States, 31405
    - Sanofi-Aventis Investigational Site Number 840165
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Sanofi-Aventis Investigational Site Number 840130
  - Idaho Falls, Idaho, United States, 83404
    - Sanofi-Aventis Investigational Site Number 840228
  - Nampa, Idaho, United States, 83686
    - Sanofi-Aventis Investigational Site Number 840143
- Illinois
  - Chicago, Illinois, United States, 60637
    - Sanofi-Aventis Investigational Site Number 840221
  - Chicago, Illinois, United States, 60664
    - Sanofi-Aventis Investigational Site Number 840206
- Indiana
  - Beaver, Indiana, United States, 15009
    - Sanofi-Aventis Investigational Site Number 840280
  - Elkhart, Indiana, United States, 46514
    - Sanofi-Aventis Investigational Site Number 840014
- Kansas
  - Wichita, Kansas, United States, 67208
    - Sanofi-Aventis Investigational Site Number 840249
- Kentucky
  - Lexington, Kentucky, United States, 40504
    - Sanofi-Aventis Investigational Site Number 840265
- Louisiana
  - Alexandria, Louisiana, United States, SUITE 250
    - Sanofi-Aventis Investigational Site Number 840047
  - Jena, Louisiana, United States, 71342
    - Sanofi-Aventis Investigational Site Number 840218
  - Lafayette, Louisiana, United States, 70503
    - Sanofi-Aventis Investigational Site Number 840247
  - Lake Charles, Louisiana, United States, 70601
    - Sanofi-Aventis Investigational Site Number 840158
  - Natchitoches, Louisiana, United States, 71457
    - Sanofi-Aventis Investigational Site Number 840077
  - Shreveport, Louisiana, United States, 71103
    - Sanofi-Aventis Investigational Site Number 840259
  - Shreveport, Louisiana, United States, 71105
    - Sanofi-Aventis Investigational Site Number 840231
  - Shreveport, Louisiana, United States, 71105
    - Sanofi-Aventis Investigational Site Number 840232
- Maine
  - Auburn, Maine, United States, 04210
    - Sanofi-Aventis Investigational Site Number 840145
- Maryland
  - Baltimore, Maryland, United States, 21237
    - Sanofi-Aventis Investigational Site Number 840017
  - Denton, Maryland, United States, 76201
    - Sanofi-Aventis Investigational Site Number 840317
- Michigan
  - Alpena, Michigan, United States, 49707
    - Sanofi-Aventis Investigational Site Number 840311
  - Brighton, Michigan, United States, 48114
    - Sanofi-Aventis Investigational Site Number 840276
  - Detroit, Michigan, United States, 48236
    - Sanofi-Aventis Investigational Site Number 840242
  - Grand Rapids, Michigan, United States, 49503
    - Sanofi-Aventis Investigational Site Number 840253
  - St. Clair Shores, Michigan, United States, 48081
    - Sanofi-Aventis Investigational Site Number 840137
- Minnesota
  - St Cloud, Minnesota, United States, 56303
    - Sanofi-Aventis Investigational Site Number 840134
- Mississippi
  - Gulfport, Mississippi, United States, 39503
    - Sanofi-Aventis Investigational Site Number 840067
  - Picayune, Mississippi, United States, 39466
    - Sanofi-Aventis Investigational Site Number 840006
- Missouri
  - St Louis, Missouri, United States, 63104
    - Sanofi-Aventis Investigational Site Number 840201
  - St. Louis, Missouri, United States, 63122
    - Sanofi-Aventis Investigational Site Number 840310
  - St. Louis, Missouri, United States, 63128
    - Sanofi-Aventis Investigational Site Number 840200
  - St. Louis, Missouri, United States, 63141
    - Sanofi-Aventis Investigational Site Number 840323
- Montana
  - Anaconda, Montana, United States, 59711
    - Sanofi-Aventis Investigational Site Number 840096
  - Butte, Montana, United States, 59701
    - Sanofi-Aventis Investigational Site Number 840008
- Nebraska
  - Fremont, Nebraska, United States, 68025
    - Sanofi-Aventis Investigational Site Number 840126
- Nevada
  - Las Vegas, Nevada, United States, 89119
    - Sanofi-Aventis Investigational Site Number 840051
  - Las Vegas, Nevada, United States, 89144
    - Sanofi-Aventis Investigational Site Number 840258
- New Jersey
  - Hamilton, New Jersey, United States, 08690
    - Sanofi-Aventis Investigational Site Number 840303
  - Linden, New Jersey, United States, 07036
    - Sanofi-Aventis Investigational Site Number 840109
  - Morristown, New Jersey, United States, 07962-1956
    - Sanofi-Aventis Investigational Site Number 840024
- New York
  - Bronx, New York, United States
    - Sanofi-Aventis Investigational Site Number 840284
  - Buffalo, New York, United States, 14209
    - Sanofi-Aventis Investigational Site Number 840102
  - Johnson City, New York, United States, 13790
    - Sanofi-Aventis Investigational Site Number 840152
  - Rochester, New York, United States, 14607
    - Sanofi-Aventis Investigational Site Number 840159
  - Westfield, New York, United States, 14787
    - Sanofi-Aventis Investigational Site Number 840056
- North Carolina
  - Greensboro, North Carolina, United States, 27401
    - Sanofi-Aventis Investigational Site Number 840277
  - Greensboro, North Carolina, United States, 27408
    - Sanofi-Aventis Investigational Site Number 840196
  - Hickory, North Carolina, United States, 28602
    - Sanofi-Aventis Investigational Site Number 840127
  - Raleigh, North Carolina, United States, 27615
    - Sanofi-Aventis Investigational Site Number 840150
  - Rocky Mount, North Carolina, United States, 27804
    - Sanofi-Aventis Investigational Site Number 840185
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - Sanofi-Aventis Investigational Site Number 840020
- Ohio
  - Centerville, Ohio, United States, 45459
    - Sanofi-Aventis Investigational Site Number 840197
  - Cincinnati, Ohio, United States, 45267-0525
    - Sanofi-Aventis Investigational Site Number 840074
  - Cleveland, Ohio, United States, 44109
    - Sanofi-Aventis Investigational Site Number 840146
  - Gallipolis, Ohio, United States, 45631
    - Sanofi-Aventis Investigational Site Number 840292
  - Mason, Ohio, United States, 45040
    - Sanofi-Aventis Investigational Site Number 840026
  - Toledo, Ohio, United States, 43608
    - Sanofi-Aventis Investigational Site Number 840233
  - Wadsworth, Ohio, United States, 44281
    - Sanofi-Aventis Investigational Site Number 840064
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Sanofi-Aventis Investigational Site Number 840045
  - Tulsa, Oklahoma, United States, 74104
    - Sanofi-Aventis Investigational Site Number 840133
- Oregon
  - Bend, Oregon, United States, 97701
    - Sanofi-Aventis Investigational Site Number 840113
  - Portland, Oregon, United States, 97220
    - Sanofi-Aventis Investigational Site Number 840257
- Pennsylvania
  - Indiana, Pennsylvania, United States, 15701
    - Sanofi-Aventis Investigational Site Number 840304
  - Philadelphia, Pennsylvania, United States, 19102
    - Sanofi-Aventis Investigational Site Number 840128
  - Philadelphia, Pennsylvania, United States, 19143
    - Sanofi-Aventis Investigational Site Number 840160
  - Philadelphia, Pennsylvania, United States, 19149
    - Sanofi-Aventis Investigational Site Number 840339
  - Pittsburgh, Pennsylvania, United States, 15240
    - Sanofi-Aventis Investigational Site Number 840181
  - Scotland, Pennsylvania, United States, 17254
    - Sanofi-Aventis Investigational Site Number 840229
  - Stoneboro, Pennsylvania, United States, 16153
    - Sanofi-Aventis Investigational Site Number 840072
- Rhode Island
  - Cranston, Rhode Island, United States, 02920
    - Sanofi-Aventis Investigational Site Number 840248
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Sanofi-Aventis Investigational Site Number 840261
  - Anderson, South Carolina, United States, 29621
    - Sanofi-Aventis Investigational Site Number 840297
  - Camden, South Carolina, United States, 29020
    - Sanofi-Aventis Investigational Site Number 840172
  - Columbia, South Carolina, United States, 29201
    - Sanofi-Aventis Investigational Site Number 840168
  - Manning, South Carolina, United States, 29102
    - Sanofi-Aventis Investigational Site Number 840122
  - Newberry, South Carolina, United States, 29108
    - Sanofi-Aventis Investigational Site Number 840085
  - Pelzer, South Carolina, United States, 29669
    - Sanofi-Aventis Investigational Site Number 840189
- South Dakota
  - Fort Meade, South Dakota, United States, 57741
    - Sanofi-Aventis Investigational Site Number 840032
- Tennessee
  - Athens, Tennessee, United States, 37303
    - Sanofi-Aventis Investigational Site Number 840062
  - Bristol, Tennessee, United States, 37620
    - Sanofi-Aventis Investigational Site Number 840048
  - Bristol, Tennessee, United States, 37620
    - Sanofi-Aventis Investigational Site Number 840052
  - Cleveland, Tennessee, United States, 37312
    - Sanofi-Aventis Investigational Site Number 840104
  - Johnson City, Tennessee, United States, 37614
    - Sanofi-Aventis Investigational Site Number 840129
  - Nashville, Tennessee, United States, 37203
    - Sanofi-Aventis Investigational Site Number 840269
- Texas
  - Amarillo, Texas, United States, 79106
    - Sanofi-Aventis Investigational Site Number 840076
  - Corsicana, Texas, United States, 75110
    - Sanofi-Aventis Investigational Site Number 840252
  - Houston, Texas, United States, 77070
    - Sanofi-Aventis Investigational Site Number 840286
  - Irving, Texas, United States, 75061
    - Sanofi-Aventis Investigational Site Number 840132
  - Odessa, Texas, United States, 79761
    - Sanofi-Aventis Investigational Site Number 840005
  - Odessa, Texas, United States, 79761
    - Sanofi-Aventis Investigational Site Number 840289
  - San Antonio, Texas, United States, 78234
    - Sanofi-Aventis Investigational Site Number 840186
  - San Antonio, Texas, United States, 78238
    - Sanofi-Aventis Investigational Site Number 840194
  - Temple, Texas, United States, 76508
    - Sanofi-Aventis Investigational Site Number 840236
  - Victoria, Texas, United States, 77901
    - Sanofi-Aventis Investigational Site Number 840011
  - Wichita Falls, Texas, United States, 76309
    - Sanofi-Aventis Investigational Site Number 840285
- Utah
  - Clinton, Utah, United States, 84015
    - Sanofi-Aventis Investigational Site Number 840223
  - Salt Lake City, Utah, United States, 84124
    - Sanofi-Aventis Investigational Site Number 840238
  - Salt Lake City, Utah, United States, 84124
    - Sanofi-Aventis Investigational Site Number 840308
- Virginia
  - Salem, Virginia, United States, 24153
    - Sanofi-Aventis Investigational Site Number 840068
  - Springfield, Virginia, United States, 22151
    - Sanofi-Aventis Investigational Site Number 840219
- Washington
  - Everett, Washington, United States, 98201
    - Sanofi-Aventis Investigational Site Number 840058
  - Seattle, Washington, United States, 98111
    - Sanofi-Aventis Investigational Site Number 840123
  - Tacoma, Washington, United States, 98405
    - Sanofi-Aventis Investigational Site Number 840019
- Wisconsin
  - Beloit, Wisconsin, United States, 53511
    - Sanofi-Aventis Investigational Site Number 840256
  - Madison, Wisconsin, United States, 53713
    - Sanofi-Aventis Investigational Site Number 840293
  - Wauwatosa, Wisconsin, United States, 53226
    - Sanofi-Aventis Investigational Site Number 840282
Venezuela
- - Caracas, Venezuela
    - Sanofi-Aventis Investigational Site Number 862001
  - Maracay, Venezuela, 2103
    - Sanofi-Aventis Investigational Site Number 862002

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:

Non valvular atrial fibrillation (AF)
Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.

Main exclusion Criteria:

Indication for VKA other than AF
Stroke or TIA within previous 5 days
Transient AF caused by a reversible disorder
Planned major surgery/trauma or cardioversion within 30 days
INR > 3 at baseline
Active bleeding or high risk of bleeding
Uncontrolled hypertension
Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.

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: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Idrabiotaparinux Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).	Drug: Placebo (for warfarin) Warfarin matching capsules Oral administration Drug: Idrabiotaparinux sodium Pre-filled syringes containing: 0.5 mL for the 3.0 mg dosage; 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years). Subcutaneous injection Other Names: SSR126517 Biotinylated idraparinux Drug: Avidin Vial containing 105 mg of lyophilized powder for dilution Intravenous infusion for 30 minutes Other Names: SSR29261
Active Comparator: Warfarin Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.	Drug: Warfarin Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration Drug: Placebo (for idrabiotaparinux) Matching pre-filled syringes containing: 0.5 mL for the 3.0 mg dosage; 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years). Subcutaneous injection Drug: Placebo (for avidin) Vial containing 105 mg of matching lyophilized powder for dissolution Intravenous infusion for 30 minutes

Participant Group / Arm

Intervention / Treatment

Experimental: Idrabiotaparinux

Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months.

Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).

Drug: Placebo (for warfarin)

Warfarin matching capsules

Oral administration

Drug: Idrabiotaparinux sodium

Pre-filled syringes containing:

0.5 mL for the 3.0 mg dosage;
0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).

Subcutaneous injection

Other Names:

SSR126517
Biotinylated idraparinux

Drug: Avidin

Vial containing 105 mg of lyophilized powder for dilution

Intravenous infusion for 30 minutes

Other Names:

SSR29261

Active Comparator: Warfarin

Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.

Drug: Warfarin

Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)

Oral administration

Drug: Placebo (for idrabiotaparinux)

Matching pre-filled syringes containing:

0.5 mL for the 3.0 mg dosage;
0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).

Subcutaneous injection

Drug: Placebo (for avidin)

Vial containing 105 mg of matching lyophilized powder for dissolution

Intravenous infusion for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) Time Frame: From randomization up to the end of the treatment period (minimum of 6 months)	From randomization up to the end of the treatment period (minimum of 6 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Components of the primary study outcome measure: Time Frame: From randomization up to the end of the treatment period (minimum of 6 months)	From randomization up to the end of the treatment period (minimum of 6 months)
Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death Time Frame: From randomization up to the end of the treatment period (minimum of 6 months)	From randomization up to the end of the treatment period (minimum of 6 months)

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

Buller HR, Halperin J, Hankey GJ, Pillion G, Prins MH, Raskob GE. Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis-Atrial Fibrillation Study. J Thromb Haemost. 2014 Jun;12(6):824-30. doi: 10.1111/jth.12546.

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

December 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 24, 2007

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC10295
2007-004817-33 (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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Atrial Fibrillation

Clinical Trials on Placebo (for warfarin)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations