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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Investigative Site Frankurt am Main, Germany, 60528 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rheinfelden, Germany, 79618 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Witten, Germany, 58455 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Mergentheim, Germany, 97980 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 19, France, 75019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEVIN, France, 62806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BOIS-GUILLAUME, France, 76230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NICE, France, 06000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONACO, France, 98000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SOYAUX, France, 16800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bydgoszcz, Poland, 85-094 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdansk, Poland, 80-803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakow, Poland, 31-826 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fürth, Germany, 90766 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 65929 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Garmisch-Partenkirchen, Germany, 82467 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sommerfeld, Germany, 16766 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bremen, Germany, 28177 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 14, France, 75877 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site STRASBOURG, France, 67098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANTES CEDEX, France, 44277 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLERMONT FERRAND, France, 63050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 20, France, 75960 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 71-252 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-718 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alghero, Italy, 07041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Udine, Italy, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lecco, Italy, 23900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jaén, Spain, 23007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pamplona, Spain, 31008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site C/ Plató, 21, Spain, 08006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Castelló de la Plana, Spain, 12004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burlington, Canada, L7R 4C4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ajax, Canada, L1S 2J4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oshawa, Canada, L1G 2B9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 04-141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 91-002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Abano Terme, Italy, 35031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parma, Italy, 43126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varese, Italy, 21100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alcorcón, Spain, 28922 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitchener, Canada, N2G 1G3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Peterborough, Canada, K9J 7C6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Penticton, Canada, V2A 5C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1Y 4E9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANTWERPEN, Belgium, 2020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MERKSEM, Belgium, 2170 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HOOFDDORP, Netherlands, 2134 TM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HILVERSUM, Netherlands, 1213 XZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEIDEN, Netherlands, 2334 CK | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hermosillo, Mexico, 83000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kungälv, Sweden, 442 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halmstad, Sweden, 301 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jönköping, Sweden, 551 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hässleholm, Sweden, 281 25 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hellerup, Denmark, DK-2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Windsor, Canada, N9A 1E1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oakville, Canada, L6J 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saint John, Canada, E2L 4L2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PELLENBERG, Belgium, 3212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site REET, Belgium, 2840 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6522 JV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zwolle, Netherlands, 8011 JW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oss, Netherlands, 5342 BT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guadalajara, Mexico, 44280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chihuahua, Chih., Mexico, 31000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varberg, Sweden, 432 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lidköping, Sweden, 531 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Falköping, Sweden, 521 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gjövik, Norway, 2819 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kongsvinger, Norway, 2212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Worcester, South Africa, 6850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle, South Africa, 2940 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bloemfontein, South Africa, 9301 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plzen, Czech Republic, 304 60 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zerifin, Israel, 6093000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medellín, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Silkeborg, Denmark, 8600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hørsholm, Denmark, DK-2970 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frederiksberg, Denmark, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Elverum, Norway, 2409 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lillehammer, Norway, 2609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Namsos, Norway, 7800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4092 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Randburg, South Africa, 2125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PRETORIA, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 8, Czech Republic, 180 81 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kolin, Czech Republic, 280 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Callao, Peru, CALLAO 2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pardubice, Czech Republic, 530 03 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jihlava, Czech Republic, 586 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Havlickuv Brod, Czech Republic, 580 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chomutov, Czech Republic, 430 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar-Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holon, Israel, 58220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cali, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lima, Peru, LIMA 1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lima, Peru, LIMA 11 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a controlled., double-blind, randomized study of BAY 59-7939 in the prevention of VTE in subjects undergoing elective total knee replacement.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causesTimeframe: Treatment period: up to Day 13+/-4
Secondary Outcome
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)Timeframe: Treatment period: up to Day 13+/-4
- Incidence of symptomatic VTE (DVT, PE)Timeframe: Treatment period: up to Day 13+/-4
- Incidence of DVT (total, proximal, distal)Timeframe: Treatment period: up to Day 13+/-4
- Incidence of symptomatic VTE during follow-upTimeframe: Follow-up period: following 13+/-4 days
- The composite endpoint comprising major VTE and treatment-emergent major bleedingTimeframe: For major VTE, treatment period: up to Day 13+/-4 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all deathTimeframe: Treatment period: up to Day 13+/-4
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related deathTimeframe: Treatment period: up to Day 13+/-4
- Treatment-emergent major bleedingsTimeframe: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Additional Information
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