Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

3,212

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Venous ThromboembolismCancer
Interventions
DRUG

Semuloparin sodium

"0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe~Subcutaneous injection"

DRUG

Placebo (for semuloparin)

"0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component~Subcutaneous injection"

Trial Locations (411)

400

Investigational Site Number 710003, Durban

500

Investigational Site Number 158004, Changhua

1020

Investigational Site Number 056011, Brussels

1070

Investigational Site Number 620004, Lisbon

1076

Investigational Site Number 348005, Budapest

1079

Investigational Site Number 428003, Riga

1090

Investigational Site Number 040003, Vienna

1106

Investigational Site Number 348006, Budapest

1121

Investigational Site Number 348009, Budapest

1125

Investigational Site Number 348004, Budapest

1130

Investigational Site Number 040004, Vienna

1264

Investigational Site Number 032003, Capital Federal

1340

Investigational Site Number 056012, Ottignies

1425

Investigational Site Number 032006, Buenos Aires

2000

Investigational Site Number 705002, Maribor

2145

Investigational Site Number 036008, Westmead

2170

Investigational Site Number 056004, Merksem

2480

Investigational Site Number 036009, Lismore

2730

Investigational Site Number 208001, Herlev

2820

Investigational Site Number 056008, Bonheiden

3128

Investigational Site Number 036001, Box Hill

3135

Investigational Site Number 036006, Ringwood East

3233

Investigational Site Number 348012, Mátraháza

3401

Investigational Site Number 428002, Liepāja

3800

Investigational Site Number 348008, Szikszó

4000

Investigational Site Number 056009, Liège

4091

Investigational Site Number 710002, Durban

4102

Investigational Site Number 036005, Woolloongabba

4204

Investigational Site Number 705003, Golnik

5000

Investigational Site Number 036004, Adelaide

Investigational Site Number 348011, Szolnok

5001

Investigational Site Number 756006, Aarau

5007

Investigational Site Number 250020, Gap

5011

Investigational Site Number 036003, Woodville

5042

Investigational Site Number 036002, Bedford Park

5700

Investigational Site Number 348001, Gyula

6000

Investigational Site Number 036007, Perth

7002

Investigational Site Number 100001, Rousse

7100

Investigational Site Number 056010, Haine-Saint-Paul

8036

Investigational Site Number 040002, Graz

8401

Investigational Site Number 756004, Winterthur

8500

Investigational Site Number 056006, Kortrijk

8582

Investigational Site Number 348010, Farkasgyepű

8900

Investigational Site Number 348007, Zalaegerszeg

9000

Investigational Site Number 056005, Ghent

9010

Investigational Site Number 100003, Varna

9700

Investigational Site Number 348003, Sopron

10000

Investigational Site Number 191008, Zagreb

10117

Investigational Site Number 276025, Berlin

10167

Investigational Site Number 233001, Tallinn

11000

Investigational Site Number 688002, Belgrade

11080

Investigational Site Number 688004, Belgrade

11527

Investigational Site Number 300004, Athens

11900

Investigational Site Number 458004, George Town

Investigational Site Number 458005, George Town

13125

Investigational Site Number 276016, Berlin

13210

Investigational Site Number 840031, Syracuse

13273

Investigational Site Number 250001, Marseille

13353

Investigational Site Number 276002, Berlin

13585

Investigational Site Number 276029, Berlin

14642

Investigational Site Number 840024, Rochester

15006

Investigational Site Number 203003, Prague

18000

Investigational Site Number 688005, Niš

18009

Investigational Site Number 804008, Cherkasy

20010

Investigational Site Number 840052, Washington D.C.

20017

Investigational Site Number 840025, Washington D.C.

20136

Investigational Site Number 360004, Medan

20230

Investigational Site Number 484006, Aguascalientes

20817

Investigational Site Number 840042, Bethesda

21053

Investigational Site Number 380005, Castellanza

21601

Investigational Site Number 840066, Easton

22100

Investigational Site Number 376001, Nahariya

22457

Investigational Site Number 276037, Hamburg

23000

Investigational Site Number 191003, Zadar

23100

Investigational Site Number 380004, Sondrio

24047

Investigational Site Number 380003, Treviglio

24634

Investigational Site Number 276013, Neumünster

25198

Investigational Site Number 724011, Lleida

26100

Investigational Site Number 380015, Cremona

26121

Investigational Site Number 276022, Oldenburg

26202

Investigational Site Number 203007, Nová Ves pod Pleší

26655

Investigational Site Number 276024, Westerstede

26789

Investigational Site Number 276020, Leer

27262

Investigational Site Number 840026, High Point

27710

Investigational Site Number 840020, Durham

Investigational Site Number 840021, Durham

28020

Investigational Site Number 203008, Kolín

28034

Investigational Site Number 724001, Madrid

Investigational Site Number 724007, Madrid

28035

Investigational Site Number 724013, Madrid

28040

Investigational Site Number 724012, Madrid

30076

Investigational Site Number 840070, Roswell

30625

Investigational Site Number 276007, Hanover

32005

Investigational Site Number 724005, Ourense

32207

Investigational Site Number 840019, Jacksonville

32427

Investigational Site Number 276003, Minden

32955

Investigational Site Number 840051, Rockledge

33098

Investigational Site Number 276035, Paderborn

33100

Investigational Site Number 380017, Udine

33756

Investigational Site Number 840074, Clearwater

34000

Investigational Site Number 688007, Kragujevac

34094

Investigational Site Number 250024, Montpellier

34239

Investigational Site Number 840073, Sarasota

34260

Investigational Site Number 484007, Durango

35211

Investigational Site Number 840006, Birmingham

35570

Investigational Site Number 250017, Saint-Grégoire

38801

Investigational Site Number 840059, Tupelo

39104

Investigational Site Number 276017, Magdeburg

39670

Investigational Site Number 484002, Acapulco

40005

Investigational Site Number 804011, Sumy

40161

Investigational Site Number 360002, Bandung

40202

Investigational Site Number 840014, Louisville

40353

Investigational Site Number 840048, Mount Sterling

42000

Investigational Site Number 191007, Varaždin

43018

Investigational Site Number 804001, Lutsk

43100

Investigational Site Number 380011, Parma

43560

Investigational Site Number 840022, Sylvania

44281

Investigational Site Number 376004, Kfar Saba

44791

Investigational Site Number 276004, Bochum

45042

Investigational Site Number 840003, Middletown

45136

Investigational Site Number 276030, Essen

46017

Investigational Site Number 724002, Valencia

46023

Investigational Site Number 804004, Ternopil

46237

Investigational Site Number 840010, Indianapolis

46520

Investigational Site Number 724003, Port de Sagunt

46526

Investigational Site Number 840033, Goshen

47014

Investigational Site Number 380001, Meldola

47023

Investigational Site Number 380007, Cesena

47861

Investigational Site Number 380014, Cattolica

47900

Investigational Site Number 380016, Rimini

48018

Investigational Site Number 380009, Faenza

48022

Investigational Site Number 380006, Lugo

48121

Investigational Site Number 380013, Ravenna

48903

Investigational Site Number 724008, Barakaldo

Investigational Site Number 724010, Barakaldo

49100

Investigational Site Number 376006, Petah Tikva

49102

Investigational Site Number 804002, Dnipropetrovsk

50005

Investigational Site Number 203004, Hradec Králové

50048

Investigational Site Number 804005, Kryvyi Rih

50120

Investigational Site Number 484003, Toluca

50603

Investigational Site Number 458003, Kuala Lumpur

51000

Investigational Site Number 191005, Rijeka

51100

Investigational Site Number 250021, Reims

51109

Investigational Site Number 276006, Cologne

52100

Investigational Site Number 191006, Pula

54500

Investigational Site Number 250014, Vandœuvre-lès-Nancy

54629

Investigational Site Number 300002, Thessaloniki

58001

Investigational Site Number 804009, Chernivtsi

58501

Investigational Site Number 840046, Bismarck

59020

Investigational Site Number 250005, Lille

Investigational Site Number 250025, Lille

59037

Investigational Site Number 250012, Lille

60068

Investigational Site Number 840016, Park Ridge

60077

Investigational Site Number 840008, Skokie

62301

Investigational Site Number 840028, Quincy

65929

Investigational Site Number 276005, Frankfurt am Main

68024

Investigational Site Number 250010, Colmar

68167

Investigational Site Number 276011, Mannheim

69003

Investigational Site Number 250003, Lyon

70056

Investigational Site Number 840047, Metairie

70300

Investigational Site Number 376007, Tzrifin

71110

Investigational Site Number 300003, Heraklion

71270

Investigational Site Number 840032, Ruston

72550

Investigational Site Number 484012, Puebla City

73100

Investigational Site Number 380012, Lecce

75475

Investigational Site Number 250006, Paris

Investigational Site Number 250027, Paris

75674

Investigational Site Number 250004, Paris

76031

Investigational Site Number 250019, Rouen

77030

Investigational Site Number 840034, Houston

77055

Investigational Site Number 840035, Sugar Land

77701

Investigational Site Number 840067, Beaumont

78224

Investigational Site Number 276008, Singen

79031

Investigational Site Number 804010, Lviv

79915

Investigational Site Number 840004, El Paso

80114

Investigational Site Number 360001, Denpasar

81377

Investigational Site Number 276021, München

81545

Investigational Site Number 276019, München

81737

Investigational Site Number 276015, München

82131

Investigational Site Number 276032, Gauting

83022

Investigational Site Number 276023, Rosenheim

83092

Investigational Site Number 804006, Donetsk

85222

Investigational Site Number 840007, Casa Grande

85704

Investigational Site Number 840060, Tucson

86150

Investigational Site Number 276012, Augsburg

88996

Investigational Site Number 458001, Kota Kinabalu

90806

Investigational Site Number 840009, Long Beach

91031

Investigational Site Number 376003, Jerusalem

91130

Investigational Site Number 484010, Xalapa

91750

Investigational Site Number 840069, La Verne

91775

Investigational Site Number 703003, Trnava

91790

Investigational Site Number 840029, West Covina

92056

Investigational Site Number 840001, Oceanside

92210

Investigational Site Number 840037, Indian Wells

92270

Investigational Site Number 840011, Rancho Mirage

92708

Investigational Site Number 840050, Fountain Valley

92835

Investigational Site Number 840072, Fullerton

94032

Investigational Site Number 276031, Passau

97000

Investigational Site Number 484008, Mérida

98039

Investigational Site Number 380008, Taormina

98431

Investigational Site Number 840018, Tacoma

99336

Investigational Site Number 840063, Kennewick

100029

Investigational Site Number 156014, Beijing

100071

Investigational Site Number 156008, Beijing

101149

Investigational Site Number 156022, Beijing

110060

Investigational Site Number 356002, New Delhi

116011

Investigational Site Number 156003, Dalian

130021

Investigational Site Number 156031, Changchun

150040

Investigational Site Number 643003, Yaroslavl

196084

Investigational Site Number 643009, Saint Petersburg

197089

Investigational Site Number 643014, Saint Petersburg

Investigational Site Number 643015, Saint Petersburg

197758

Investigational Site Number 643011, Saint Petersburg

200032

Investigational Site Number 156024, Shanghai

200072

Investigational Site Number 156028, Shanghai

200233

Investigational Site Number 156020, Shanghai

200433

Investigational Site Number 156011, Shanghai

210603

Investigational Site Number 112004, Vitebsk

214000

Investigational Site Number 643019, Smolensk

215004

Investigational Site Number 156012, Suzhou

220013

Investigational Site Number 112003, Minsk

223040

Investigational Site Number 112001, Minsk

246012

Investigational Site Number 112002, Homyel

249036

Investigational Site Number 643010, Obninsk

266003

Investigational Site Number 156029, Qingdao

300041

Investigational Site Number 642008, Timișoara

300053

Investigational Site Number 643016, Tula

310016

Investigational Site Number 156026, Hangzhou

344037

Investigational Site Number 643023, Rostov-on-Don

354057

Investigational Site Number 643021, Sochi

357502

Investigational Site Number 643022, Pyatigorsk

394000

Investigational Site Number 643017, Voronezh

400015

Investigational Site Number 642001, Cluj-Napoca

Investigational Site Number 642006, Cluj-Napoca

400026

Investigational Site Number 356001, Mumbai

400037

Investigational Site Number 156019, Chongqing

410004

Investigational Site Number 643020, Saratov

411001

Investigational Site Number 356004, Pune

411004

Investigational Site Number 356024, Pune

420111

Investigational Site Number 643001, Kazan'

450054

Investigational Site Number 643012, Ufa

454087

Investigational Site Number 643006, Chelyabinsk

500004

Investigational Site Number 356015, Hyderabad

Investigational Site Number 356025, Hyderabad

500117

Investigational Site Number 642004, Brasov

510405

Investigational Site Number 156025, Guangzhou

515041

Investigational Site Number 156013, Shantou

530002

Investigational Site Number 356012, Visakhapatnam

530021

Investigational Site Number 156030, Nanning

560029

Investigational Site Number 356006, Bangalore

610083

Investigational Site Number 156021, Chengdu

625023

Investigational Site Number 643018, Tyumen

633190

Investigational Site Number 643024, Berdsk

634050

Investigational Site Number 643008, Tomsk

641037

Investigational Site Number 356019, Coimbatore

644013

Investigational Site Number 643005, Omsk

660113

Investigational Site Number 643004, Krasnoyarsk

690105

Investigational Site Number 643007, Vladivostok

700026

Investigational Site Number 356003, Kolkata

700106

Investigational Site Number 642010, Iași

710032

Investigational Site Number 156004, Xi'an

710038

Investigational Site Number 156009, Xi'an

720237

Investigational Site Number 642003, Suceava

750004

Investigational Site Number 156027, Yinchuan

4810469

Investigational Site Number 152002, Temuco

06360

Investigational Site Number 840005, Norwich

06790

Investigational Site Number 840064, Torrington

06525

Investigational Site Number 840038, Woodbridge

02915

Investigational Site Number 840075, East Providence

S200PBJ

Investigational Site Number 032004, Rosario

T4000IAK

Investigational Site Number 032007, San Miguel de Tucumán

T4000NIL

Investigational Site Number 032005, San Miguel de Tucumán

Unknown

Investigational Site Number 056003, Ostend

Investigational Site Number 056002, Sint-Niklaas

Investigational Site Number 124007, Kelowna

Investigational Site Number 170010, Bogotá

Investigational Site Number 170005, Manizales

Investigational Site Number 170002, Medellín

Investigational Site Number 170006, Medellín

Investigational Site Number 170007, Medellín

Investigational Site Number 170008, Montería

Investigational Site Number 170004, Pereira

Investigational Site Number 191001, Zagreb

Investigational Site Number 191004, Zagreb

Investigational Site Number 344001, Hong Kong

Investigational Site Number 356008, Bangalore

Investigational Site Number 356018, Chennai

Investigational Site Number 356020, Chennai

Investigational Site Number 356011, Jaipur

Investigational Site Number 356014, Kochi

Investigational Site Number 356013, Kolkata

Investigational Site Number 356017, Kolkata

Investigational Site Number 356005, Madurai

Investigational Site Number 356016, Miraj

Investigational Site Number 356023, Nagpur

Investigational Site Number 372004, Dublin

Investigational Site Number 604012, Arequipa

Investigational Site Number 604001, Cercado

Investigational Site Number 604002, Chiclayo

Investigational Site Number 604003, Lima

30150-221

Investigational Site Number 076002, Belo Horizonte

80730 170

Investigational Site Number 076022, Curitiba

81520-060

Investigational Site Number 076015, Curitiba

88015-240

Investigational Site Number 076012, Florianópolis

60336-550

Investigational Site Number 076001, Fortaleza

74070-040

Investigational Site Number 076009, Goiânia

74605-070

Investigational Site Number 076007, Goiânia

Investigational Site Number 076016, Goiânia

98700 000

Investigational Site Number 076024, Ijuí

89202-000

Investigational Site Number 076003, Joinville

86050-190

Investigational Site Number 076010, Londrina

99010-080

Investigational Site Number 076026, Passo Fundo

99010-260

Investigational Site Number 076027, Passo Fundo

90020-090

Investigational Site Number 076023, Porto Alegre

90430-090

Investigational Site Number 076020, Porto Alegre

40050-410

Investigational Site Number 076014, Salvador

41825-010

Investigational Site Number 076018, Salvador

09090-780

Investigational Site Number 076011, Santo André

12245-750

Investigational Site Number 076006, São José dos Campos

04039-901

Investigational Site Number 076008, São Paulo

04122 000

Investigational Site Number 076017, São Paulo

72115-700

Investigational Site Number 076004, Taguatinga

J4V 2H1

Investigational Site Number 124008, Greenfield Park

E1C 8X3

Investigational Site Number 124010, Moncton

H3T 1E2

Investigational Site Number 124003, Montreal

K1Y 4E9

Investigational Site Number 124002, Ottawa

N4K 2J1

Investigational Site Number 124009, Owen Sound

G5L 5T1

Investigational Site Number 124006, Rimouski

E2L 4L2

Investigational Site Number 124013, Saint John

J1H 5N4

Investigational Site Number 124001, Sherbrooke

V8R 6V5

Investigational Site Number 124012, Victoria

M9N 1N8

Investigational Site Number 124011, Weston

FIN-20520

Investigational Site Number 246001, Turku

06606

Investigational Site Number 250002, Antibes

01219

Investigational Site Number 276014, Dresden

01307

Investigational Site Number 276009, Dresden

06120

Investigational Site Number 276034, Halle

Investigational Site Number 276038, Halle

04207

Investigational Site Number 276010, Leipzig

462 001 (M.P)

Investigational Site Number 356009, Bhopal

D24

Investigational Site Number 372003, Dublin

D9

Investigational Site Number 372002, Dublin

06128

Investigational Site Number 380020, Perugia

03039

Investigational Site Number 380010, Sora

05100

Investigational Site Number 380019, Terni

LV-1002

Investigational Site Number 428001, Riga

06080

Investigational Site Number 440001, Kaunas

LT-08661

Investigational Site Number 440002, Vilnius

9728 NT

Investigational Site Number 528004, Groningen

5707 HA

Investigational Site Number 528005, Helmond

2134 TM

Investigational Site Number 528001, Hoofddorp

3083 AN

Investigational Site Number 528003, Rotterdam

2545 CH

Investigational Site Number 528006, The Hague

0407

Investigational Site Number 578001, Oslo

CALLAO 02

Investigational Site Number 604004, Callao

Investigational Site Number 604011, Callao

LIMA 11

Investigational Site Number 604008, Lima

LIMA 13

Investigational Site Number 604007, Lima

Investigational Site Number 604009, Lima

LIMA 34

Investigational Site Number 604005, Lima

Investigational Site Number 604006, Lima

Investigational Site Number 604010, Lima

15-069

Investigational Site Number 616009, Bialystok

43-300

Investigational Site Number 616008, Bielsko-Biala

44-101

Investigational Site Number 616006, Gliwice

31-826

Investigational Site Number 616004, Krakow

59-300

Investigational Site Number 616003, Lubin

10-228

Investigational Site Number 616019, Olsztyn

05-400

Investigational Site Number 616021, Otwock

60-569

Investigational Site Number 616010, Poznan

82-550

Investigational Site Number 616001, Prabuty

44-200

Investigational Site Number 616014, Rybnik

35-021

Investigational Site Number 616005, Rzeszów

87-100

Investigational Site Number 616013, Torun

00-416

Investigational Site Number 616018, Warsaw

02-097

Investigational Site Number 616002, Warsaw

53-439

Investigational Site Number 616015, Wroclaw

3814-501

Investigational Site Number 620003, Aveiro

4835-044

Investigational Site Number 620009, Guimarães

4454-509

Investigational Site Number 620008, Matosinhos Municipality

4200-072

Investigational Site Number 620007, Porto

2910-446

Investigational Site Number 620002, Setúbal

022328

Investigational Site Number 642002, Bucharest

700-712

Investigational Site Number 410008, Daegu

110-744

Investigational Site Number 410007, Seoul

120-752

Investigational Site Number 410001, Seoul

Investigational Site Number 410002, Seoul

135-710

Investigational Site Number 410006, Seoul

136-705

Investigational Site Number 410005, Seoul

137-701

Investigational Site Number 410003, Seoul

152-703

Investigational Site Number 410009, Seoul

442-060

Investigational Site Number 410004, Suwon

08036

Investigational Site Number 724004, Barcelona

07014

Investigational Site Number 724006, Islas Baleares

416 85

Investigational Site Number 752003, Gothenburg

792 85

Investigational Site Number 752005, Mora

751 85

Investigational Site Number 752002, Uppsala

351 85

Investigational Site Number 752001, Vaxjo

LL57 2PW

Investigational Site Number 826016, Bangor

BN2 5BE

Investigational Site Number 826010, Brighton

CV2 2DX

Investigational Site Number 826015, Coventry

DD1 9SY

Investigational Site Number 826013, Dundee

HU8 9HE

Investigational Site Number 826007, Hull

LN2 5QY

Investigational Site Number 826002, Lincoln

Investigational Site Number 826017, Lincoln

M20 4BX

Investigational Site Number 826005, Manchester

CH63 4JY

Investigational Site Number 826014, Metropolitan Borough of Wirral

NR4 7UY

Investigational Site Number 826004, Norwich

PE3 6DA

Investigational Site Number 826009, Peterborough

PO3 6AD

Investigational Site Number 826011, Portsmouth

SY3 8XQ

Investigational Site Number 826001, Shrewsbury

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY