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.
NCT ID: NCT00361894
Last Updated: 2014-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2531 participants
INTERVENTIONAL
2006-02-28
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm 1
Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
Arm 2
Enoxaparin
Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days
Interventions
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Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
Enoxaparin
Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare Pharmaceuticals Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Linz, Upper Austria, Austria
Vienna, Vienna, Austria
Antwerp, , Belgium
Hasselt, , Belgium
Liège, , Belgium
Merksem, , Belgium
Pellenberg, , Belgium
Reet, , Belgium
Roeselare, , Belgium
Penticton, British Columbia, Canada
Saint John, New Brunswick, Canada
Burlington, Ontario, Canada
Kitchener, Ontario, Canada
Oakville, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Scarborough Village, Ontario, Canada
Windsor, Ontario, Canada
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Bogotá, , Colombia
Cali, , Colombia
Medellín, , Colombia
Prague, Tschechien, Czechia
Brno, , Czechia
Chomutov, , Czechia
Havlíčkův Brod, , Czechia
Jihlava, , Czechia
Kolín, , Czechia
Pardubice, , Czechia
Pilsen, , Czechia
Frederiksberg, , Denmark
Hellerup, , Denmark
Herlev, , Denmark
Hørsholm, , Denmark
Silkeborg, , Denmark
Bois-Guillaume, , France
Clermont-Ferrand, , France
Liévin, , France
Marseille, , France
Monaco, , France
Nantes, , France
Nice, , France
Nice, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Soyaux, , France
Vandœuvre-lès-Nancy, , France
Bad Mergentheim, Baden-Wurttemberg, Germany
Rheinfelden, Baden-Wurttemberg, Germany
Fürth, Bavaria, Germany
Garmisch-Partenkirchen, Bavaria, Germany
Würzburg, Bavaria, Germany
Sommerfeld, Brandenburg, Germany
Bremen, City state Bremen, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Witten, North Rhine-Westphalia, Germany
Beersheba, Israel, Israel
Haifa, Israel, Israel
Holon, Israel, Israel
Kfar Saba, Israel, Israel
Tel Aviv, Israel, Israel
Ẕerifin, Israel, Israel
Tel Litwinsky, , Israel
San Donato Milanese, Milano, Italy
Abano Terme, Padova, Italy
Gubbio, Perugia, Italy
Alghero, Sassari, Italy
Bologna, , Italy
Florence, , Italy
Lecco, , Italy
Padua, , Italy
Parma, , Italy
Roma, , Italy
Udine, , Italy
Varese, , Italy
Chihuahua, Chih., Chihuahua, Mexico
Guadalajara, Jalisco, Mexico
Hermosillo, Sonora, Mexico
Amsterdam, , Netherlands
Hilversum, , Netherlands
Hoofddorp, , Netherlands
Leiden, , Netherlands
Nijmegen, , Netherlands
Oss, , Netherlands
Zwolle, , Netherlands
Elverum, , Norway
Gjøvik, , Norway
Kongsvinger, , Norway
Lillehammer, , Norway
Namsos, , Norway
Callao, , Peru
Lima, , Peru
Lima, , Peru
Bialystok, , Poland
Bydgoszcz, , Poland
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Lublin, , Poland
Szczecin, , Poland
Warsaw, , Poland
Warsaw, , Poland
Bloemfontein, Freestate, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Randburg, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Newcastle, KwaZulu-Natal, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Castellon, Castellón de La Plana, Spain
Jaén, Jaén, Spain
Alcorcón, Madrid, Spain
Madrid, Madrid, Spain
Pamplona, Pamplona, Spain
Valencia, Valencia, Spain
Falköping, , Sweden
Gothenburg, , Sweden
Halmstad, , Sweden
Hässleholm, , Sweden
Jönköping, , Sweden
Kungälv, , Sweden
Lidköping, , Sweden
Varberg, , Sweden
Countries
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References
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Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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EudraCT: 2005-004620-40
Identifier Type: -
Identifier Source: secondary_id
11356
Identifier Type: -
Identifier Source: org_study_id
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