Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

4,413

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Venous Thromboembolism
Interventions
DRUG

Semuloparin Sodium

"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe~Subcutaneous injection"

DRUG

Enoxaparin sodium

"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe~Subcutaneous injection"

DRUG

Placebo

"0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component~Subcutaneous injection"

Trial Locations (270)

1039

Investigational Site Number 032007, Capital Federal

1155

Investigational Site Number 032002, Buenos Aires

1407

Investigational Site Number 100011, Sofia

1416

Investigational Site Number 032001, Buenos Aires

1606

Investigational Site Number 100005, Sofia

Investigational Site Number 100008, Sofia

Investigational Site Number 100009, Sofia

2000

Investigational Site Number 032012, Rosario

Investigational Site Number 705002, Maribor

2143

Investigational Site Number 348009, Kistarcsa

2217

Investigational Site Number 036001, Kogarah

2400

Investigational Site Number 208001, København NV

3000

Investigational Site Number 705001, Celje

3022

Investigational Site Number 804005, Kyiv

3128

Investigational Site Number 036002, Box Hill

Investigational Site Number 036003, Box Hill

3600

Investigational Site Number 056002, Genk

4020

Investigational Site Number 036008, Redcliffe

4032

Investigational Site Number 348007, Debrecen

4600

Investigational Site Number 040002, Wels

5000

Investigational Site Number 208002, Odense C

Investigational Site Number 348003, Szolnok

5800

Investigational Site Number 100004, Pleven

6720

Investigational Site Number 348008, Szeged

6850

Investigational Site Number 710003, Worcester

7002

Investigational Site Number 100003, Rousse

7006

Investigational Site Number 578001, Trondheim

7010

Investigational Site Number 554002, Nelson South

7130

Investigational Site Number 710001, Cape Town

8000

Investigational Site Number 348004, Székesfehérvár

8011

Investigational Site Number 554003, Christchurch

8014

Investigational Site Number 554001, Christchurch

8036

Investigational Site Number 040001, Graz

9000

Investigational Site Number 056001, Ghent

9010

Investigational Site Number 100006, Varna

Investigational Site Number 100010, Varna

10000

Investigational Site Number 191002, Zagreb

11080

Investigational Site Number 688001, Belgrade

Investigational Site Number 688004, Belgrade

13419

Investigational Site Number 233003, Tallinn

14059

Investigational Site Number 203008, Prague

14186

Investigational Site Number 752001, Stockholm

15006

Investigational Site Number 203006, Prague

15240

Investigational Site Number 840006, Pittsburgh

16132

Investigational Site Number 380001, Genova

Investigational Site Number 380015, Genova

16902

Investigational Site Number 203002, Prague

18009

Investigational Site Number 804003, Cherkasy

18435

Investigational Site Number 276001, Stralsund

20097

Investigational Site Number 380011, San Donato Milanese

20132

Investigational Site Number 380006, Milan

21000

Investigational Site Number 688002, Novi Sad

23538

Investigational Site Number 276014, Lübeck

25001

Investigational Site Number 203016, Říčany

26506

Investigational Site Number 840043, Morgantown

28007

Investigational Site Number 724002, Madrid

28020

Investigational Site Number 203015, Kolín

29100

Investigational Site Number 380013, Piacenza

30625

Investigational Site Number 276012, Hanover

31904

Investigational Site Number 840009, Columbus

32209

Investigational Site Number 840017, Jacksonville

32804

Investigational Site Number 840015, Orlando

33081

Investigational Site Number 380009, Aviano

33136

Investigational Site Number 840044, Miami

33170

Investigational Site Number 380012, Pordenone

33756

Investigational Site Number 840029, Clearwater

34000

Investigational Site Number 191004, Požega

34147

Investigational Site Number 792003, Istanbul

34149

Investigational Site Number 380007, Trieste

34390

Investigational Site Number 792001, Istanbul

35128

Investigational Site Number 380004, Padua

35209

Investigational Site Number 840026, Birmingham

Investigational Site Number 840035, Birmingham

Investigational Site Number 840042, Birmingham

35234

Investigational Site Number 840002, Birmingham

35360

Investigational Site Number 792007, Izmir

39130

Investigational Site Number 276016, Magdeburg

40113

Investigational Site Number 203010, Ústí nad Labem

41701

Investigational Site Number 840037, Hazard

42100

Investigational Site Number 380005, Reggio Emilia

43100

Investigational Site Number 380008, Parma

43210

Investigational Site Number 840051, Columbus

43464

Investigational Site Number 203014, Most

44340

Investigational Site Number 484001, Guadalajara

44575

Investigational Site Number 276015, Castrop-Rauxel

Investigational Site Number 276018, Castrop-Rauxel

44791

Investigational Site Number 276011, Bochum

46063

Investigational Site Number 203004, Liberec

50406

Investigational Site Number 233001, Tartu

Investigational Site Number 233002, Tartu

52100

Investigational Site Number 191001, Pula

53203

Investigational Site Number 203012, Pardubice

58633

Investigational Site Number 203011, Jihlava

60153

Investigational Site Number 840019, Maywood

61037

Investigational Site Number 804011, Kharkiv

62500

Investigational Site Number 203007, Brno

62702

Investigational Site Number 840036, Springfield

63104

Investigational Site Number 840008, St Louis

65025

Investigational Site Number 804008, Odesa

65691

Investigational Site Number 203001, Brno

66421

Investigational Site Number 276004, Homburg

69120

Investigational Site Number 276002, Heidelberg

71110

Investigational Site Number 300002, Heraklion

72880

Investigational Site Number 203003, Ostrava

76755

Investigational Site Number 203009, Kroměříž

77024

Investigational Site Number 840025, Houston

77070

Investigational Site Number 840050, Houston

79409

Investigational Site Number 840032, Lubbock

80262

Investigational Site Number 840021, Denver

81675

Investigational Site Number 276013, München

82110

Investigational Site Number 484006, Mazatlán

82324

Investigational Site Number 840031, Corlton

83092

Investigational Site Number 804007, Donetsk

Investigational Site Number 804010, Donetsk

90033

Investigational Site Number 840014, Los Angeles

92647

Investigational Site Number 840007, Huntingdon Beach

93105

Investigational Site Number 840011, Sant Barbara

105229

Investigational Site Number 643003, Moscow

110085

Investigational Site Number 356009, New Delhi

115280

Investigational Site Number 643001, Moscow

119048

Investigational Site Number 643002, Moscow

119415

Investigational Site Number 643020, Moscow

119991

Investigational Site Number 643021, Moscow

125367

Investigational Site Number 643025, Moscow

141001

Investigational Site Number 356032, Ludhiana

150062

Investigational Site Number 643014, Yaroslavl

188640

Investigational Site Number 643016, Vsevolozhsk

191104

Investigational Site Number 643011, Saint Petersburg

194291

Investigational Site Number 643010, Saint Petersburg

194354

Investigational Site Number 643009, Saint Petersburg

195067

Investigational Site Number 643018, Saint Petersburg

197706

Investigational Site Number 643015, Sestroretsk

199004

Investigational Site Number 643017, Saint Petersburg

210006

Investigational Site Number 156005, Nanjing

210603

Investigational Site Number 112004, Vitebsk

220013

Investigational Site Number 112003, Minsk

223040

Investigational Site Number 112008, Minsk

226014

Investigational Site Number 356003, Lucknow

246012

Investigational Site Number 112001, Homyel

Investigational Site Number 112006, Homyel

266003

Investigational Site Number 156008, Qingdao

300121

Investigational Site Number 156014, Tianjin

300736

Investigational Site Number 642002, Timișoara

302013

Investigational Site Number 356002, Jaipur

350086

Investigational Site Number 643019, Krasnodar

354200

Investigational Site Number 156006, Fuzhou

380006

Investigational Site Number 356025, Gujarat

400006

Investigational Site Number 642003, Cluj-Napoca

400015

Investigational Site Number 642006, Cluj-Napoca

400132

Investigational Site Number 642005, Cluj-Napoca

410008

Investigational Site Number 156012, Changsha

410013

Investigational Site Number 156010, Changsha

410169

Investigational Site Number 642001, Oradea

Investigational Site Number 642004, Oradea

411001

Investigational Site Number 356015, Pune

500004

Investigational Site Number 356028, Hyderabad

500082

Investigational Site Number 356010, Hyderabad

510060

Investigational Site Number 156003, Guangzhou

560029

Investigational Site Number 356027, Bangalore

560054

Investigational Site Number 356019, Banglore

570208

Investigational Site Number 156013, Haikou

600010

Investigational Site Number 356018, Chennai

600035

Investigational Site Number 356016, Chennai

600101

Investigational Site Number 356021, Chennai

630047

Investigational Site Number 643008, Novosibirsk

630054

Investigational Site Number 643007, Novosibirsk

634063

Investigational Site Number 643012, Tomsk

641037

Investigational Site Number 356006, Coimbatore

644013

Investigational Site Number 643026, Omsk

660058

Investigational Site Number 643006, Krasnoyarsk

682026

Investigational Site Number 356013, Kochi

682304

Investigational Site Number 356007, Kochi

710038

Investigational Site Number 156004, Xi'an

07666

Investigational Site Number 840020, Teaneck

Unknown

Investigational Site Number 032004, Buenos Aires

Investigational Site Number 112002, Minsk

Investigational Site Number 112005, Minsk

Investigational Site Number 112007, Vitebsk

Investigational Site Number 152002, Rancagua

Investigational Site Number 356033, Andhra Pradesh

Investigational Site Number 356008, Bangalore

Investigational Site Number 356031, Bhopal

Investigational Site Number 356022, Jaipur

Investigational Site Number 356026, Lucknow

Investigational Site Number 356001, Mangalore

Investigational Site Number 356030, Nagpur

Investigational Site Number 356012, Punjgutta

Investigational Site Number 604004, Callao

Investigational Site Number 616006, Gdansk

Investigational Site Number 710004, Cape Town

Investigational Site Number 792006, Istanbul

Investigational Site Number 804002, Kyiv

Investigational Site Number 804004, Kyiv

C1408INH

Investigational Site Number 032008, Capital Federal

X5000AAI

Investigational Site Number 032014, Córdoba

S3000EPV

Investigational Site Number 032005, Santa Fe

30150-221

Investigational Site Number 076003, Belo Horizonte

30380-490

Investigational Site Number 076010, Belo Horizonte

95001-960

Investigational Site Number 076014, Caxias do Sul

80050-350

Investigational Site Number 076012, Curitiba

81520-060

Investigational Site Number 076005, Curitiba

74605-070

Investigational Site Number 076006, Goiânia

89202-000

Investigational Site Number 076011, Joinville

90035 003

Investigational Site Number 076007, Porto Alegre

90610-000

Investigational Site Number 076009, Porto Alegre

14049-900

Investigational Site Number 076015, Ribeirão Preto

15090-000

Investigational Site Number 076013, São José do Rio Preto

01323-001

Investigational Site Number 076004, São Paulo

05403-000

Investigational Site Number 076002, São Paulo

08270-070

Investigational Site Number 076008, São Paulo

T6G 2B7

Investigational Site Number 124001, Edmonton

N2G 1G3

Investigational Site Number 124004, Kitchener

H3G 1A4

Investigational Site Number 124010, Montreal

T4N 4E6

Investigational Site Number 124011, Red Deer

E2L 4L2

Investigational Site Number 124009, Saint John

P7B 6V1

Investigational Site Number 124002, Thunder Bay

V5Z 4E3

Investigational Site Number 124007, Vancouver

838-0456

Investigational Site Number 152001, Santiago

014010

Investigational Site Number 156011, Baotou

050051

Investigational Site Number 156001, Shijiazhuang

01067

Investigational Site Number 276006, Dresden

380 006

Investigational Site Number 356005, Ahmedabad

380 008

Investigational Site Number 356004, Ahmedabad

560 034

Investigational Site Number 356011, Bangalore

600 096

Investigational Site Number 356014, Chennai

411 011

Investigational Site Number 356023, Pune

LV-5417

Investigational Site Number 428004, Daugavpils

LV-1002

Investigational Site Number 428003, Riga

LV-1038

Investigational Site Number 428002, Riga

LT-47144

Investigational Site Number 440003, Kaunas

LT-50009

Investigational Site Number 440001, Kaunas

LT-10207

Investigational Site Number 440002, Vilnius

Callao 02

Investigational Site Number 604003, Callao

LIMA 11

Investigational Site Number 604006, Lima

LIMA 13

Investigational Site Number 604001, Lima

LIMA 18

Investigational Site Number 604005, Lima

Lima 29

Investigational Site Number 604002, Lima

85-094

Investigational Site Number 616001, Bydgoszcz

85-168

Investigational Site Number 616003, Bydgoszcz

31-501

Investigational Site Number 616005, Krakow

31-826

Investigational Site Number 616018, Krakow

31-913

Investigational Site Number 616020, Krakow

90-153

Investigational Site Number 616009, Lodz

90-647

Investigational Site Number 616002, Lodz

20-081

Investigational Site Number 616010, Lublin

60-747

Investigational Site Number 616012, Poznan

41-200

Investigational Site Number 616015, Sosnowiec

70-111

Investigational Site Number 616013, Szczecin

87-100

Investigational Site Number 616011, Torun

02-097

Investigational Site Number 616004, Warsaw

03-242

Investigational Site Number 616014, Warsaw

50 -556

Investigational Site Number 616008, Wroclaw

50-326

Investigational Site Number 616007, Wroclaw

51-124

Investigational Site Number 616016, Wroclaw

821 01

Investigational Site Number 703001, Bratislava

700-712

Investigational Site Number 410007, Daegu

410-773

Investigational Site Number 410006, Goyang

420-767

Investigational Site Number 410001, Gyeonggi-do

400-711

Investigational Site Number 410009, Incheon

110-744

Investigational Site Number 410011, Seoul

120-752

Investigational Site Number 410004, Seoul

135-710

Investigational Site Number 410002, Seoul

135-720

Investigational Site Number 410010, Seoul

138-878

Investigational Site Number 410008, Seoul

443-721

Investigational Site Number 410003, Suwon

08907

Investigational Site Number 724001, Barcelona

442 83

Investigational Site Number 752002, Kungälv

601 82

Investigational Site Number 752004, Norrköping

432 81

Investigational Site Number 752003, Varberg

SE5 9PJ

Investigational Site Number 826001, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT00679588 - Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery | Biotech Hunter | Biotech Hunter