Trial Condition(s):

Venous Thromboembolism

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. (RECORD 4)

Bayer Identifier:

11355

ClinicalTrials.gov Identifier:

NCT00362232

EudraCT Number:

2006-002402-60

Study Completed

Trial Purpose

The purpose of this study is to assess if 10 mg BAY59-7939, 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 Low Molecular Weight Heparin (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
3148
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Gill Orthopedic Center

Lubbock, United States, 79410

Status
Completed
 
Locations

Arizona Research Center, Inc.

Phoenix, United States, 85023

Status
Completed
 
Locations

Jacksonville Center for Clinical Research

Jacksonville, United States, 32216

Status
Completed
 
Locations

West Alabama Research, Inc.

Tuscaloosa, United States, 35406

Status
Completed
 
Locations

Oklahoma City VA Medical Center

Oklahoma City, United States, 73162

Status
Completed
 
Locations

Center for Joint Care

Missoula, United States, 59802

Status
Completed
 
Locations

Capstone Clinical Trials, Inc.

Birmingham, United States, 35209

Status
Completed
 
Locations

Advanced Orthopedic & Sports Medicine Specialists

Denver, United States, 80230

Status
Completed
 
Locations

Scripps Center of Orthopaedic Research & Education

La Jolla, United States, 92037

Status
Completed
 
Locations

Harbor - UCLA Medical Center

Torrance, United States, 90502-2004

Status
Completed
 
Locations

Southeastern Center for Clinical Trials

Decatur, United States, 30033

Status
Completed
 
Locations

Lubbock Sports Medicine

Lubbock, United States, 79410

Status
Completed
 
Locations

Presbyterian Hospital of Dallas

Dallas, United States, 75231

Status
Completed
 
Locations

Texas Center for Joint Replacement

Plano, United States, 75093

Status
Completed
 
Locations

Intermountain Research Center

Boise, United States, 83702

Status
Completed
 
Locations

Holy Name Medical Center

Teaneck, United States, 07666

Status
Completed
 
Locations

Charleston Orthopaedic Associates

Charleston, United States, 29414

Status
Completed
 
Locations

Teton Research, LLC

Little Rock, United States, 72205

Status
Completed
 
Locations

Unlimited Research, LP

San Antonio, United States, 78233

Status
Completed
 
Locations

Wellington Orthopaedic & Sports Medicine

Cincinnati, United States, 45242

Status
Completed
 
Locations

Orthopedic Specialty Clinic

Spokane, United States, 99218

Status
Completed
 
Locations

Baptist Clinical Research

Pensacola, United States, 32501

Status
Completed
 
Locations

Bone & Joint Clinic of Houston

Houston, United States, 77030

Status
Completed
 
Locations

Research Alliance Inc.

Clearwater, United States, 33756

Status
Completed
 
Locations

Orthopaedic Associates of South Broward

Hollywood, United States, 33021

Status
Completed
 
Locations

Texas Orthopedic Specialists

Grapevine, United States, 76051

Status
Completed
 
Locations

Orthopaedic Associates

Towson, United States, 21204

Status
Completed
 
Locations

Visions Clinical Research

Boynton Beach, United States, 33472-2952

Status
Completed
 
Locations

Advent Clinical Research Centers, Inc.

Pinellas Park, United States, 33781

Status
Completed
 
Locations

Florida Orthopedic Associates, PA

DeLand, United States, 32720

Status
Completed
 
Locations

Nautical Clinical Research

Meridian, United States, 83642

Status
Completed
 
Locations

Peak Orthopedics, PLLC

Centennial, United States, 80112

Status
Completed
 
Locations

CORE Orthopaedic Medical Center

Encinitas, United States, 92024

Status
Completed
 
Locations

Sports Medicine and Orthopaedics Center

Greensboro, United States, 27401

Status
Completed
 
Locations

Colorado Orthopaedic Consultants, PC

Englewood, United States, 80110

Status
Completed
 
Locations

Office of Dr. Brian E. Gunnlaugson, MD

Johnstown, United States, 15901

Status
Completed
 
Locations

Shreenath Clinical Services

Fountain Valley, United States, 92708

Status
Completed
 
Locations

Sutter North Medical Foundation

Yuba City, United States, 95991

Status
Completed
 
Locations

Southern California Orthopedic Institute

Bakersfield, United States, 93309

Status
Completed
 
Locations

Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen

Warszawa, Poland, 02-005

Status
Completed
 
Locations

Szpital Specjalistyczny im. Zeromskiego SPZOZ

Krakow, Poland, 31-913

Status
Completed
 
Locations

University Orthopedics Center

State College, United States, 16801

Status
Completed
 
Locations

Martin, Bowen & Hefley Knee and Sports Medicine

Little Rock, United States, 72205

Status
Completed
 
Locations

California Physician's Research Alliance

Encinitas, United States, 92024

Status
Completed
 
Locations

San Antonio Medical Associates

San Antonio, United States, 78205

Status
Completed
 
Locations

Wojewódzki Szpital Zespolony

Kielce, Poland

Status
Completed
 
Locations

Wojewodzki Szpital Zespolony

Elblag, Poland, 82-300

Status
Completed
 
Locations

Szpital Specjalistyczny Sw. Lukasza

Konskie, Poland, 26-200

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Gdansk, Poland, 80-803

Status
Completed
 
Locations

Office of Dr. Gordon Kruger, MD

Woodstock, Canada, N4S 5B2

Status
Completed
 
Locations

Brant Community Healthcare System

Brantford, Canada, N3R 1G9

Status
Completed
 
Locations

Dr. Everett Chalmers Hospital

Fredericton, Canada, E3B 5N5

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Szpital Uniwersytecki im. Antoniego Jurasza

Bydgoszcz, Poland, 85-094

Status
Completed
 
Locations

CSK MSWiA

Warszawa, Poland, 02-507

Status
Completed
 
Locations

Wojewodzki Szpital Specjalistyczny nr 5

Sosnowiec, Poland, 41-200

Status
Completed
 
Locations

Montreal General Hospital

Montreal, Canada, H3G 1A4

Status
Completed
 
Locations

Queen Elizabeth Hospital

Charlottetown, Canada, C1A 8T5

Status
Completed
 
Locations

Scarbororgh Hospital-Grace Division

Scarborough, Canada, M1M 3W3

Status
Completed
 
Locations

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Canada, P7B 6V4

Status
Completed
 
Locations

Rouge Valley Health System

Ajax, Canada, L1S 2J4

Status
Completed
 
Locations

Lakeridge Health-Oshawa

Oshawa, Canada, L1G 2B9

Status
Completed
 
Locations

Ottawa Hospital - Civic Campus

Ottawa, Canada, K1Y 4E9

Status
Completed
 
Locations

Hosp. de Especialidades C.M.N. Lic. Ignacio García Téllez

Mérida, Mexico, 97150

Status
Completed
 
Locations

Hospital de Traumatologia y Ortopedia Lomas Verdes IMSS

Edo. de Mexico, Mexico, 53120

Status
Completed
 
Locations

Hospital General Regional No. 46 IMSS

Guadalajara, Mexico, 44350

Status
Completed
 
Locations

Hospital General Regional No. 45

Guadalajara, Mexico, 44200

Status
Completed
 
Locations

Hässleholms Sjukhus

Hässleholm, Sweden, 281 25

Status
Completed
 
Locations

Scarbororgh Hospital-General Division

Scarborough, Canada, M1P 2V5

Status
Completed
 
Locations

Central Alberta Research

Red Deer, Canada, T4N 6V7

Status
Completed
 
Locations

Medical Arts Health Research Group

Penticton, Canada, V2A 5C8

Status
Completed
 
Locations

Peterborough Regional Health Centre

Peterborough, Canada, K9J 7C6

Status
Completed
 
Locations

Office of Dr.Wayne Pisesky, MD

Kelowna, Canada, V1W 4V5

Status
Completed
 
Locations

Office of Dr. Paul Zalzal, MD

Oakville, Canada, L6J 3M5

Status
Completed
 
Locations

Medicor Research, Inc.

Sudbury, Canada, P3A 1Y8

Status
Completed
 
Locations

Hospital Regional ISSSTE Monterrey

Monterrey, Mexico, 64380

Status
Completed
 
Locations

Hospital Regional "Valentín Gómez Farías"

Zapopan, Mexico, 45100

Status
Completed
 
Locations

Hospital de Traumatologia y Ortopedia No 21 IMSS

Monterrey, Mexico, 64000

Status
Completed
 
Locations

SU/Östra

Göteborg, Sweden, 416 85

Status
Completed
 
Locations

Västerviks Sjukhus

Västervik, Sweden, 593 81

Status
Completed
 
Locations

Växjö Centrallasarett

Växjö, Sweden, 351 85

Status
Completed
 
Locations

Regionshospitalet Silkeborg

Silkeborg, Denmark, 8600

Status
Completed
 
Locations

Sykehuset Innlandet HF Lillehammer

Lillehammer, Norway, 2609

Status
Terminated
 
Locations

Martina Hansens Hospital

Baerum postterminal, Norway, 1306

Status
Terminated
 
Locations

Capio S:t Görans Sjukhus AB

Stockholm, Sweden, 112 81

Status
Completed
 
Locations

Örebro Universitetssjukhus

Örebro, Sweden, 701 85

Status
Completed
 
Locations

Herlev Hospital

Herlev, Denmark, 2730

Status
Completed
 
Locations

Gentofte Hospital

Hellerup, Denmark, DK-2900

Status
Completed
 
Locations

Hvidovre Hospital

Hvidovre, Denmark, 2650

Status
Completed
 
Locations

Nordsjællands Hospital - Hørsholm

Hørsholm, Denmark, 2970

Status
Completed
 
Locations

Viborg Sygehus

Viborg, Denmark, 8800

Status
Completed
 
Locations

Sykehuset Innlandet HF Kongsvinger

Kongsvinger, Norway, 2212

Status
Terminated
 
Locations

Sykehuset Innlandet HF Gjøvik

Gjövik, Norway, 2819

Status
Terminated
 
Locations

Assaf Harofeh Medical Center

Zerifin, Israel, 70300

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Military Medical Academy

Sofia, Bulgaria, 1431

Status
Completed
 
Locations

MHAT

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

Vilnius University Hospital of Emergency Care

Vilnius, Lithuania, LT-04130

Status
Completed
 
Locations

Klaipeda University Hospital

Klaipeda, Lithuania, 92288

Status
Completed
 
Locations

Hip and Knee Clinic Fracture and Orthopaedic Hospital

Ahmedabad, India, 380006

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel, 44281

Status
Completed
 
Locations

Soroka University Medical Center

Beer Sheva, Israel, 85025

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 49100

Status
Completed
 
Locations

UMHAT "Sveti Georgi"

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Kaunas Medical University Hospital

Kaunas, Lithuania, LT-50009

Status
Completed
 
Locations

Kaunas Red Cross Clinical Hospital

Kaunas, Lithuania, 44320

Status
Completed
 
Locations

Panevezys Hospital

Panevezys, Lithuania, 35144

Status
Completed
 
Locations

Krishna Institute of Medical Sciences Ltd.

Secunderabad, India, 500 003

Status
Completed
 
Locations

Dayanand Medical College& Hospital

Ludhiana, India, 141001

Status
Completed
 
Locations

Centre for Knee Surgery

Baroda, India, 390007

Status
Completed
 
Locations

Global Hospitals

Hyderabad, India, 500004

Status
Completed
 
Locations

Deenanath Mangeshkar Hospital

Pune, India, 411009

Status
Completed
 
Locations

St John's Medical College Hospital

Bangalore, India, 560034

Status
Completed
 
Locations

Yashodha Hospital

Hyderabad, India

Status
Completed
 
Locations

Jehangir Hospital

Pune, India, 411001

Status
Completed
 
Locations

Shalby Hospital

Ahmedabad, India, 380054

Status
Completed
 
Locations

All Inida Institute of Medical Sciences

New Delhi, India, 110029

Status
Completed
 
Locations

Apollo Hospital

Chennai, India, 600 006

Status
Completed
 
Locations

Yashodha Hospital

Secundrabad, India, 500003

Status
Completed
 
Locations

Victoria Hospital

Bangalore, India, 560001

Status
Completed
 
Locations

National Medical Centre

Karachi, Pakistan

Status
Completed
 
Locations

O.M.I Hospital

Karachi, Pakistan

Status
Completed
 
Locations

Liaquat National Hospital

Karachi, Pakistan, 74800

Status
Completed
 
Locations

Sri Jayewardenepura General Hospital

Kotte, Sri Lanka

Status
Completed
 
Locations

National Hospital of Sri Lanka

Colombo-80, Sri Lanka

Status
Completed
 
Locations

Colombo North Teaching Hospital

Ragama, Sri Lanka

Status
Completed
 

Trial Design