Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

PHASE3CompletedINTERVENTIONAL
Enrollment

3,148

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

January 31, 2007

Study Completion Date

January 31, 2008

Conditions
Venous Thromboembolism
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.

DRUG

Enoxaparin

Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

DRUG

Placebo: tablet of Rivaroxaban

Placebo tablet of rivaroxaban administered once daily in the evening.

DRUG

Placebo: syringes of Enoxaparin

Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Trial Locations (124)

1306

Baerum Postterminal

1431

Sofia

2212

Kongsvinger

2609

Lillehammer

2650

Hvidovre

2730

Herlev

2819

Gjøvik

2970

Hørsholm

4002

Plovdiv

5800

Pleven

8600

Silkeborg

8800

Viborg

15901

Johnstown

16801

State College

21204

Towson

27401

Greensboro

29414

Charleston

30033

Decatur

32216

Jacksonville

32501

Pensacola

32720

DeLand

33021

Hollywood

33756

Clearwater

33781

Pinellas Park

35144

Panevezys

35209

Birmingham

35406

Tuscaloosa

44200

Guadalajara

44281

Kfar Saba

44320

Kaunas

44350

Guadalajara

45100

Zapopan

45242

Cincinnati

49100

Petah Tikva

53120

Edo. de Mexico

58100

Holon

59802

Missoula

64000

Monterrey

64239

Tel Aviv

64380

Monterrey

70300

Ẕerifin

72205

Little Rock

73162

Oklahoma City

74800

Karachi

75093

Plano

75231

Dallas

76051

Grapevine

77030

Houston

78205

San Antonio

78233

San Antonio

79410

Lubbock

80110

Englewood

80112

Centennial

80230

Denver

83642

Meridian

83702

Boise

85023

Phoenix

85025

Beersheba

92024

Encinitas

92037

La Jolla

92288

Klaipėda

92708

Fountain Valley

93309

Bakersfield

95991

Yuba City

97150

Mérida

99218

Spokane

110029

New Delhi

141001

Ludhiana

380006

Ahmedabad

380054

Ahmedabad

390007

Baroda

411001

Pune

411009

Pune

500003

Secundrabad

500004

Hyderabad

560001

Bangalore

560034

Bangalore

90502-2004

Torrance

33472-2952

Boynton Beach

07666

Teaneck

T4N 6V7

Red Deer

V1W 4V5

Kelowna

V2A 5C8

Penticton

E3B 5N5

Fredericton

L1S 2J4

Ajax

N3R 1G9

Brantford

P3A 1Y8

Greater Sudbury

L6J 3M5

Oakville

L1G 2B9

Oshawa

K1Y 4E9

Ottawa

K9J 7C6

Peterborough

M1M 3W3

Scarborough Village

M1P 2V5

Scarborough Village

P7B 6V4

Thunder Bay

N4S 5B2

Woodstock

C1A 8T5

Charlottetown

H3G 1A4

Montreal

H3T 1E2

Montreal

DK-2900

Hellerup

500 003

Secunderabad

600 006

Chennai

Unknown

Hyderabad

Karachi

Kielce

Colombo-80

Ragama

Sri Jayewardenepura Kotte

LT-50009

Kaunas

LT-04130

Vilnius

85-094

Bydgoszcz

82-300

Elblag

80-803

Gdansk

26-200

Gmina Końskie

31-913

Krakow

20-718

Lublin

41-200

Sosnowiec

02-005

Warsaw

02-507

Warsaw

416 85

Gothenburg

281 25

Hässleholm

701 85

Örebro

112 81

Stockholm

351 85

Vaxjo

593 81

Västervik

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00362232 - Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement. | Biotech Hunter | Biotech Hunter