Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

8,101

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

August 31, 2010

Study Completion Date

November 30, 2010

Conditions
Venous Thromboembolism
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days

DRUG

Enoxaparin

Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

DRUG

Rivaroxaban placebo

Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

DRUG

Enoxaparin placebo

Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Trial Locations (676)

31

Lima

114

Taipei

710

Tainan City

833

Kaohsiung City

1000

Bruxelles - Brussel

Zagreb

Ljubljana

1002

Riga

1005

Riga

1023

Auckland

1030

Vienna

1076

Budapest

1100

Vienna

Vienna

1134

Budapest

1140

Vienna

1145

Budapest

1210

Luxembourg

1211

Geneva

1221

Buenos Aires

1233

Sofia

1280

Hospital Británico, Buenos Aires

1480

Tubize

1603

Fredrikstad

1606

Sofia

1610

Kempton Park

1638

Vicente López

1657

"Hospital de Agudos Dr. Carlos Bocalandro", Tres de Febrero

1663

San Miguel

1724

Roodepoort

2000

Frederiksberg C

2005

Santarém

2024

Auckland

2057

Johannesburg

2132

Johannesburg

2196

Johannesburg

Sandton, Gauteng

2217

Kogarah

2229

Sydney

2300

Turnhout

København S

2326

Hamar

2400

Mol

København NV

2421

Kittsee

2480

Lismore

2540

Luxembourg-Kirchberg

2605

Garran

2640

Mortsel

2660

Balassagyarmat

2800

Tatabánya

2819

Gjøvik

3000

Leuven

3010

Bern

3100

Sankt Pölten

3128

Box Hill

3135

Melbourne

3144

Melbourne

3168

Clayton

3402

Liepāja

3500

Hasselt

4000

Roskilde

4012

Debrecen

4020

Redcliffe

Linz

Linz

4031

Basel

4066

Auchenflower

Brisbane

4101

Brisbane

Bruderholz

4102

Woollongabba

4204

Golnik

4215

Southport

4410

Liestal

4500

Huy

4602

Niedercorn

4901

Langenthal

4960

Malmedy

5000

Veliko Tarnovo

5042

Adelaide

5404

Baden

5800

Pleven

6000

Perth

Stara Zagora

Kolding

Kecskemét

Lucerne

6020

Innsbruck

6061

Montigny S/sambre

6500

Baja

6511

Zams

6700

Esbjerg

6800

Hódmezővásárhely

6850

Worcester

7002

Rousse

7130

Somerset West

7250

Launceston

7350

Oberpullendorf

7460

Goodwood

7505

Stellenbosch

8000

Bruges

Székesfehérvár

Novo Mesto

8011

Christchurch

8036

Graz

8091

Zurich

8113

Gratwein

8230

Hartberg

8680

Mürzzuschlag

8700

Leoben

8800

Roeselare

8900

Ieper

9010

Varna

9024

Győr

9100

Sint-Niklaas

9200

Dendermonde

9300

Aalst

9301

Bloemfontein

9400

Wolfsberg

10000

Zagreb

10011

New York

10016

Taipei

10065

New York

10138

Tallinn

10207

Vilnius

10400

Bangkok

10430

Jakarta

10595

Valhalla

10700

Bangkok

10787

Berlin

11215

Brooklyn

11340

Mexico City

11418

Jamaica

11420

Jakarta

11794

Stony Brook

12808

Prague

13419

Tallinn

13530

Hämeenlinna

14004

Córdoba

14233

Nea Ionia

14561

Kifisia / Athens

14940

Cabra

15236

Frankfurt (Oder)

15848

Beeskow

15850

Lahti

15900

Mexico City

16002

Cuenca

16128

Genoa

17007

Girona

17011

Camp Hill

17800

Olot

17822

Danville

18015

Bethlehem

18510

Scranton

18536

Piraeus

19018

Elefsina

19107

Philadelphia

19124

Philadelphia

19718

Newark

20037

Washington D.C.

20089

Milan

20133

Milan

20162

Milan

20234

Aguascalientes

20520

Turku

20700

Turku

21000

Dijon

21100

Varese

21200

Raisio

21215

Baltimore

21237

Baltimore

23000

Zadar

23249

Richmond

23298

Richmond

24128

Bergamo

25000

Besançon

26301

Clarksburg

27250

Torreón

27403

Greensboro

27710

Durham

27909

Elizabeth City

28177

Bremen

28845

Domodossola

29000

Tuxtla Gutiérrez

29121

Piacenza

29185

Kristianstad

29425

Charleston

29609

Brest

29700

Vélez

30029

Nîmes

30030

Decatur

30202

Cartagena

30342

Atlanta

30905

Fort Gordon

31048

Haifa

31350

Chihuahua City

31403

Toulouse

31405

Savannah

32960

Vero Beach

33021

Hollywood

33024

Pembroke Pines

33098

Paderborn

33136

Miami

33166

Miami Springs

33180

Aventura

33334

Fort Lauderdale

33445

Delray Beach

33458

Jupiter

33472

Boyton Beach

33756

Clearwater

33952

Port Charlotte

34098

Istanbul

34170

Castelnau-le-Lez

34232

Sarasota

34295

Montpellier

34304

Istanbul

35100

Izmir

35209

Birmingham

35235

Birmingham

35340

Izmir

35401

Tuscaloosa

35406

Tuscaloosa

36100

Vicenza

36111

Montgomery

36214

Vigo

36301

Dothan

36340

Office of Dr. John Simmons, MD, Geneva

36608

Mobile

38104

Memphis

40620

Jyväskylä

41063

Mönchengladbach

41100

Modena

41464

Neuss

41749

Viersen

42000

Saint-Etienne

42109

Wuppertal

42123

Reggio Emilia

43036

Fidenza

43100

Parma

43215

Columbus

43606

Toledo

44137

Dortmund

44280

Guadalajara

44718

Canton

44805

Saint-Herblain

46011

Anderson

46045

Oberhausen

46060

Noblesville

48081

Saint Clair Shores

48106

Ann Arbor

48201

Detroit

48202

Detroit

48341

Pontiac

48910

Lansing

49525

Grand Rapids

50009

Zaragoza

50200

Chiang Mai

50935

Cologne

51000

Rijeka

51067

Cologne

51092

Reims

51109

Cologne

51375

Leverkusen

52140

Metepec

52222

Stolberg

52428

Jülich

53130

Lappeenranta

53844

Troisdorf

54511

Vandœuvre-lès-Nancy

55131

Mainz

55417

Minneapolis

56564

Neuwied

58100

Holon

58122

Fargo

58270

Morelia

59037

Lille

59100

Roubaix

Kuala Lumpur

59160

Lomme

59208

Tourcoing

59307

Lille

59405

Great Falls

59494

Soest

60286

Surabaya

60611

Chicago

61037

Kharkiv

61070

Kharkiv

61178

Kharkiv

62000

Arras

62184

Visby

62702

Springfield

63000

Clermont-Ferrand

63110

St Louis

63141

St Louis

64128

Kansas City

64239

Tel Aviv

65009

Odesa

65025

Odesa

66061

Olathe

66480

Monterrey

67091

Strasbourg

68131

Omaha

69003

Lyon

69120

Heidelberg

69495

Pierre-Bénite

70021

Acquaviva delle Fonti

70121

New Orleans

70300

Negeri Sembilan,

70503

Lafayette

72205

Little Rock

72410

Puebla City

73730

Esslingen am Neckar

74800

Karachi

75004

Paris

75010

Paris

75110

Corsicana

75475

Paris

75500

Karachi

75877

Paris

76000

Ivano-Frankivsk

76231

Šiauliai

76307

Karlsbad

77024

Houston

77030

Houston

78218

San Antonio

78503

McAllen

78539

Edinburg

80123

Napoli

80204

Denver

81003

Pueblo

83000

Hermosillo

83003

Donetsk

83045

Donetsk

83404

Idaho Falls

84403

Ogden

86100

Campobasso

87042

Limoges

89124

Reggio Calabria

90127

Palermo

90185

Umeå

91010

Duarte

91105

Pasadena

91206

Glendale

91911

Chula Vista

92024

Encinitas

92056

Oceanside

92120

San Diego

92373

Redlands

92637

Weiden

92701

Colombes

92708

Fountain Valley

92835

Fullerton

93102

Santa Barbara

93400

Sarawak

95023

Simferopol

95124

Catania

95817

Sacramento

97001

Mérida

97980

Bad Mergentheim

98000

Zacatecas City

98201

Everett

98405

Tacoma

100005

Beijing

100020

Beijing

100029

Beijing

100034

Beijing

100037

Beijing

100044

Beijing

100050

Beijing Friendship Hosp., Beijing

Beijing

100053

Beijing

100088

Beijing

100853

Beijing

103030

Moscow

110001

Shenyang

110004

Shenyang

110015

Shenyang

115093

Moscow

115516

Moscow

116027

Dalian

117292

Moscow

119048

Moscow

119074

Singapore

119435

Moscow

125101

Moscow

125367

Moscow

138736

Seoul

141001

Ludhiana

150003

Yaroslavl

150030

Yaroslavl

168752

Singapore

169608

Singapore

200003

Shanghai

200025

Shanghai

200127

Shanghai

200233

Shanghai

210008

Nanjing

308433

Singapore

400022

Mumbai

400038

Chongqing

400042

Chongqing

410013

Changsha

411001

Pune

411011

Pune

500034

Hyderabad

500082

Hyderabad

510120

Guangzhou

510405

Guangzhou

529889

Changi General Hospital, Singapore

560052

Bangalore

560099

Bangalore

600081

Chennai

603001

Nizhny Novgorod

603035

Nizhny Novgorod

610041

Chengdu

695002

Thiruvananthapuram

710032

The 1st Affiliated Hosp of the 4th Military Med Uni, Xi'an

710061

1st Affiliated Hosp., Med College Xi'an Jiaotong Univ., Xi'an

720237

Suceava

900591

Constanța

1311001

Safed

1834111

Afula

3109601

Haifa

4428164

Kfar Saba

7610001

Rehovot

7830604

Ashkelon

90502-2004

Torrance

80033-6017

Wheat Ridge

06030

Farmington

33173-3259

Miami

50314-2611

Des Moines

71130-4228

Shreveport

04005

Biddeford

04856

Rockport

01702

Framingham

49770-2297

Petoskey

59711-2718

Anaconda

07601-1991

Hackensack

08901

New Brunswick

08876-2598

Somerville

07901

Summit

07666

Teaneck

14215-3021

Buffalo

11040-1496

New Hyde Park

43537-1899

Maumee

18711-3752

Wilkes-Barre

37232-2650

Nashville

75216-7167

Dallas

77030-4009

Houston

B1870CID

Avellaneda

C1039AAO

Sanatorio Mitre, Buenos Aires

C1431FWO

Buenos Aires

80050-350

Curitiba

90610-000

Porto Alegre

130839 970

Campinas

09190-610

Santo André

01323-001

São Paulo

04039 002

São Paulo

05403-900

São Paulo

05443000

São Paulo

T2N 2T9

Calgary

T5H 3V9

Edmonton

T6G 2B7

Edmonton

T6L 5X8

Edmonton

V5Z 1M9

Vancouver

E2L 4L2

Saint John

K9A 5W6

Cobourg

K1Y 4E9

Ottawa

M1P 2V5

Scarborough Village

M5T 2S8

Toronto

N9A 1E1

Hotel Dieu-Grace Hospital, Windsor

J4V 2H1

Greenfield Park

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

Montreal

H2W 1T8

Montreal

H3T 1M5

Montreal

G1J 1Z4

Québec

G1V 4G5

Québec

Ste-Foy

760 0448

Santiago

Unknown

Santiago

Viña del Mar

Guangzhou

Nanjing

Changchun

Shanghai

Medellín

Bogotá

Santiago de Cali

Bogotá

Medellín

Santiago de Cali

Shatin

Shatin

Noida

Lahore

Taipei

310 00

Osijek

656 91

Brno

284 30

Kutná Hora

592 31

Nové Město na Moravě

775 20

Olomouc

305 99

Pilsen

128 08

Prague

128 21

Prague

251 49

Říčany

669 02

Znojmo

EE-10617

Tallinn

EE-51014

Tartu

00290

Helsinki

06280

Nice

01067

Dresden

01307

Dresden

04289

Leipzig

01796

Pirna

06112

Halle

115 26

Abelokipi - Athens

Athens

106 76

Athens

156 69

Athens

265 04

Rio / Patras

H-8900

Zalaegerszeg-Pozva

380 054

Ahmedabad

673 004

Calicut

641 004

Coimbatore

700 099

Kolkata

600 038

Hyderabad

00161

Rome

00168

Rome

05019

Terni

06024

Perugia

06156

Perugia

04100

Latina

491-8551

Ichinomiya

487-0013

Kasugai

474-8511

Ōbu

790-0024

Matsuyama

791-0281

Tōon

910-8561

Fukui-shi

818-8516

Chikushino-shi

370-0829

Takasaki

737-0023

Kure

040-8611

Hakodate

065-0033

Sapporo

660-8511

Amagasaki

319-1113

National Hospital Organization Ibaraki Higashi Hospital, Ibaraki

920-8650

Kanazawa

025-0075

Hanamaki

243-0433

Ebina

247-8533

Kamakura

236-0051

Yokohama

783-8509

Nangoku

860-0008

Kumamoto

606-8507

Kyoto

515-8544

Matsusaka

514-1101

Tsu

514-8507

Tsu

945-8585

Kashiwazaki

901-0243

Tomigusuku

901-2132

Urasoe

574-0074

Daitō

581-0011

Yao

525-8585

Kusatsu

432-8580

Hamamatsu

152-8902

Meguro-ku

162-8655

Shinjuku-ku

750-0061

Shimonoseki

LV-5417

Daugavpils

LV-1001

Riga

LV-1038

Riga

LV-4201

Valmiera

LV-3601

Ventspils

LT-3000

Kaunas

LT-3002

Kaunas

LT-3026

Kaunas

LT-5800

Klaipėda

LT-92231

Klaipėda

LT-28142

Utena

04130

Vilnius

LT-2001

Vilnius

06760

Mexico D. F.

07460

México, D.F

06729

México, D.F.

07760

México, D.F.

3816 CP

Amersfoort

1061 AE

Amsterdam

7511 JX

Enschede

6401 CX

Heerlen

6229 HX

Maastricht

3435 CM

Nieuwegein

3083 AN

Rotterdam

6131 BK

Sittard

3582 KE

Utrecht

0622

Auckland

0319

Oslo

0407

Oslo

CALLAO 2

Callao

01

Lima

LIMA 11

Lima

LIMA 1

Lima

Lima Cercado

15-276

Bialystok

85-681

Bydgoszcz

31-066

Krakow

31-121

Krakow

20-178

Lublin

10-228

Olsztyn

97-300

Piotrkow Trybunalski

08-110

Siedlce

83-200

Starogard Gdański

70-965

Szczecin

33-100

Tarnów

03-401

Warsaw

04-141

Warsaw

04-749

Warsaw

87-800

Włocławek

3041-856

S. Martinho Do Bispo

1150-199

Lisbon

1649-035

Lisbon

4099-001

Porto

2720-276

Amadora

2750-349

Cascais

3000-075

Coimbra

1349-019

Lisbon

1849- 017

Lisbon

4454-509

Matosinhos Municipality

4200-319

Porto

4901-585

Viana do Castelo

014461

Bucharest

022328

Bucharest

041915

Bucharest

813 69

Bratislava

826 06

Bratislava

984 39

Lučenec

036 59

Martin

012 07

Žilina

0084

Pretoria

0157

Pretoria

0181

Pretoria

463-707

Gyeongi-do

110-744

Seoul National University Hospital, Seoul

156-707

Seoul Metropolitan Boramae Hospital, Seoul

463-712

Gyeonggi-do

519-763

Jeollanam-do

135-710

Seoul

08916

Badalona

08023

Barcelona

08036

Barcelona

08208

Sabadell

501 82

Borås

281 25

Hässleholm

374 80

Karlshamn

221 85

Lund

205 02

Malmo

541 85

Skövde

171 76

Stockholm

182 88

Stockholm

851 86

Sundsvall

02 091

Kiev

03680

Kiev

04112

Kiev

01105

Kyiv

790 34

Lviv

95 026

Simferopol

TS4 3BW

Middlesbrough

DG1 4EP

Dumfries

N18 1QX

London

SE5 9RS

London

L9 7JU

Liverpool

S10 2JF

Sheffield

G11 6NT

Glasgow

NE1 4LP

Newcastle upon Tyne

LS9 7TF

Leeds

W1T 4EU

London

NG7 2UH

Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

lead

Bayer

INDUSTRY