Trial Condition(s):

Prevention, Venous Thromboembolism

Regulation of coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A study of BAY 59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement. (RECORD 3)

Bayer Identifier:

11356

ClinicalTrials.gov Identifier:

NCT00361894

EudraCT Number:

2005-004620-40

Study Completed

Trial Purpose

The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Inclusion Criteria
- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement
Exclusion Criteria
- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g.  amputation of 1 leg, allergy to contrast media)

Trial Summary

Enrollment Goal
2531
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Frankurt am Main, Germany, 60528

Status
Completed
 
Locations

Investigative Site

Rheinfelden, Germany, 79618

Status
Completed
 
Locations

Investigative Site

Witten, Germany, 58455

Status
Completed
 
Locations

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Bad Mergentheim, Germany, 97980

Status
Completed
 
Locations

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PARIS CEDEX 19, France, 75019

Status
Completed
 
Locations

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LIEVIN, France, 62806

Status
Completed
 
Locations

Investigative Site

BOIS-GUILLAUME, France, 76230

Status
Completed
 
Locations

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NICE, France, 06000

Status
Completed
 
Locations

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MONACO, France, 98000

Status
Completed
 
Locations

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SOYAUX, France, 16800

Status
Completed
 
Locations

Investigative Site

Bydgoszcz, Poland, 85-094

Status
Completed
 
Locations

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Gdansk, Poland, 80-803

Status
Completed
 
Locations

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Krakow, Poland, 31-826

Status
Completed
 
Locations

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Lublin, Poland, 20-090

Status
Completed
 
Locations

Investigative Site

Fürth, Germany, 90766

Status
Completed
 
Locations

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Frankfurt, Germany, 65929

Status
Completed
 
Locations

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Garmisch-Partenkirchen, Germany, 82467

Status
Completed
 
Locations

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Sommerfeld, Germany, 16766

Status
Completed
 
Locations

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Düsseldorf, Germany, 40225

Status
Completed
 
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Bremen, Germany, 28177

Status
Completed
 
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Würzburg, Germany, 97080

Status
Completed
 
Locations

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PARIS CEDEX 14, France, 75877

Status
Completed
 
Locations

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STRASBOURG, France, 67098

Status
Completed
 
Locations

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NANTES CEDEX, France, 44277

Status
Completed
 
Locations

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MARSEILLE, France, 13008

Status
Completed
 
Locations

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CLERMONT FERRAND, France, 63050

Status
Completed
 
Locations

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PARIS, France, 75014

Status
Completed
 
Locations

Investigative Site

PARIS CEDEX 20, France, 75960

Status
Completed
 
Locations

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Szczecin, Poland, 71-252

Status
Completed
 
Locations

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Lublin, Poland, 20-718

Status
Completed
 
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Roma, Italy, 00168

Status
Completed
 
Locations

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Alghero, Italy, 07041

Status
Completed
 
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Milano, Italy, 20097

Status
Completed
 
Locations

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Padova, Italy, 35127

Status
Completed
 
Locations

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Udine, Italy, 33100

Status
Completed
 
Locations

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Lecco, Italy, 23900

Status
Completed
 
Locations

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Badalona, Spain, 08916

Status
Completed
 
Locations

Investigative Site

Jaén, Spain, 23007

Status
Completed
 
Locations

Investigative Site

Pamplona, Spain, 31008

Status
Completed
 
Locations

Investigative Site

C/ Plató, 21, Spain, 08006

Status
Completed
 
Locations

Investigative Site

Castelló de la Plana, Spain, 12004

Status
Completed
 
Locations

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Burlington, Canada, L7R 4C4

Status
Completed
 
Locations

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Ajax, Canada, L1S 2J4

Status
Completed
 
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Oshawa, Canada, L1G 2B9

Status
Completed
 
Locations

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Bialystok, Poland, 15-276

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Completed
 
Locations

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Warszawa, Poland, 04-141

Status
Completed
 
Locations

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Lodz, Poland, 91-002

Status
Completed
 
Locations

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Warszawa, Poland, 02-637

Status
Completed
 
Locations

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Bologna, Italy, 40136

Status
Completed
 
Locations

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Abano Terme, Italy, 35031

Status
Completed
 
Locations

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Perugia, Italy, 06024

Status
Completed
 
Locations

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Parma, Italy, 43126

Status
Completed
 
Locations

Investigative Site

Firenze, Italy, 50139

Status
Completed
 
Locations

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Varese, Italy, 21100

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46010

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 
Locations

Investigative Site

Alcorcón, Spain, 28922

Status
Completed
 
Locations

Investigative Site

Kitchener, Canada, N2G 1G3

Status
Completed
 
Locations

Investigative Site

Peterborough, Canada, K9J 7C6

Status
Completed
 
Locations

Investigative Site

Penticton, Canada, V2A 5C8

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1Y 4E9

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

ANTWERPEN, Belgium, 2020

Status
Completed
 
Locations

Investigative Site

MERKSEM, Belgium, 2170

Status
Completed
 
Locations

Investigative Site

HASSELT, Belgium, 3500

Status
Completed
 
Locations

Investigative Site

HOOFDDORP, Netherlands, 2134 TM

Status
Completed
 
Locations

Investigative Site

HILVERSUM, Netherlands, 1213 XZ

Status
Completed
 
Locations

Investigative Site

LEIDEN, Netherlands, 2334 CK

Status
Completed
 
Locations

Investigative Site

Hermosillo, Mexico, 83000

Status
Completed
 
Locations

Investigative Site

Kungälv, Sweden, 442 83

Status
Completed
 
Locations

Investigative Site

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

Investigative Site

Halmstad, Sweden, 301 85

Status
Completed
 
Locations

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Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Investigative Site

Hässleholm, Sweden, 281 25

Status
Completed
 
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Investigative Site

Hellerup, Denmark, DK-2900

Status
Completed
 
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Windsor, Canada, N9A 1E1

Status
Completed
 
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Oakville, Canada, L6J 3M5

Status
Completed
 
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Investigative Site

Saint John, Canada, E2L 4L2

Status
Completed
 
Locations

Investigative Site

ROESELARE, Belgium, 8800

Status
Completed
 
Locations

Investigative Site

PELLENBERG, Belgium, 3212

Status
Completed
 
Locations

Investigative Site

REET, Belgium, 2840

Status
Completed
 
Locations

Investigative Site

NIJMEGEN, Netherlands, 6522 JV

Status
Completed
 
Locations

Investigative Site

Zwolle, Netherlands, 8011 JW

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands

Status
Completed
 
Locations

Investigative Site

Oss, Netherlands, 5342 BT

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico, 44280

Status
Completed
 
Locations

Investigative Site

Chihuahua, Chih., Mexico, 31000

Status
Completed
 
Locations

Investigative Site

Varberg, Sweden, 432 81

Status
Completed
 
Locations

Investigative Site

Lidköping, Sweden, 531 85

Status
Completed
 
Locations

Investigative Site

Falköping, Sweden, 521 85

Status
Completed
 
Locations

Investigative Site

Gjövik, Norway, 2819

Status
Completed
 
Locations

Investigative Site

Kongsvinger, Norway, 2212

Status
Completed
 
Locations

Investigative Site

Worcester, South Africa, 6850

Status
Completed
 
Locations

Investigative Site

Newcastle, South Africa, 2940

Status
Completed
 
Locations

Investigative Site

Bloemfontein, South Africa, 9301

Status
Completed
 
Locations

Investigative Site

Pretoria, South Africa, 0084

Status
Completed
 
Locations

Investigative Site

Plzen, Czech Republic, 304 60

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Zerifin, Israel, 6093000

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 6423906

Status
Completed
 
Locations

Investigative Site

Linz, Austria, 4010

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1140

Status
Completed
 
Locations

Investigative Site

Bogotá, Colombia

Status
Completed
 
Locations

Investigative Site

Medellín, Colombia

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200233

Status
Completed
 
Locations

Investigative Site

Silkeborg, Denmark, 8600

Status
Completed
 
Locations

Investigative Site

Hørsholm, Denmark, DK-2970

Status
Completed
 
Locations

Investigative Site

Frederiksberg, Denmark, 2000

Status
Completed
 
Locations

Investigative Site

Herlev, Denmark, 2730

Status
Completed
 
Locations

Investigative Site

Elverum, Norway, 2409

Status
Completed
 
Locations

Investigative Site

Lillehammer, Norway, 2609

Status
Completed
 
Locations

Investigative Site

Namsos, Norway, 7800

Status
Completed
 
Locations

Investigative Site

Durban, South Africa, 4092

Status
Completed
 
Locations

Investigative Site

Randburg, South Africa, 2125

Status
Completed
 
Locations

Investigative Site

Pretoria, South Africa

Status
Completed
 
Locations

Investigative Site

Somerset West, South Africa, 7130

Status
Completed
 
Locations

Investigative Site

PRETORIA, South Africa

Status
Completed
 
Locations

Investigative Site

Johannesburg, South Africa, 2193

Status
Completed
 
Locations

Investigative Site

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Investigative Site

Praha 8, Czech Republic, 180 81

Status
Completed
 
Locations

Investigative Site

Kolin, Czech Republic, 280 00

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100044

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100035

Status
Completed
 
Locations

Investigative Site

Callao, Peru, CALLAO 2

Status
Completed
 
Locations

Investigative Site

Pardubice, Czech Republic, 530 03

Status
Completed
 
Locations

Investigative Site

Jihlava, Czech Republic, 586 01

Status
Completed
 
Locations

Investigative Site

Havlickuv Brod, Czech Republic, 580 01

Status
Completed
 
Locations

Investigative Site

Chomutov, Czech Republic, 430 01

Status
Completed
 
Locations

Investigative Site

Kfar-Saba, Israel, 4428164

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Holon, Israel, 58220

Status
Completed
 
Locations

Investigative Site

Beer Sheva, Israel, 8410101

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Investigative Site

Cali, Colombia

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100853

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200025

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200032

Status
Completed
 
Locations

Investigative Site

Lima, Peru, LIMA 1

Status
Completed
 
Locations

Investigative Site

Lima, Peru, LIMA 11

Status
Completed
 
Locations

Investigative Site

Many locations, Israel

Status
Completed
 

Trial Design