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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00839826 |
Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply. The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.
Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.
Condition | Intervention | Phase |
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Thromboembolism Prevention |
Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial |
Enrollment: | 600 |
Study Start Date: | December 2002 |
Study Completion Date: | December 2003 |
Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 2: Active Comparator |
Drug: Enoxaparin
40 mg bid
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Arm 1: Experimental |
Drug: Rivaroxaban (BAY59-7939)
2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Wien, Austria, 1220 | |
Austria, Niederösterreich | |
Wiener Neustadt, Niederösterreich, Austria, 2700 | |
Austria, Oberösterreich | |
Linz, Oberösterreich, Austria, 4010 | |
Belgium | |
BAUDOUR, Belgium, 7331 | |
BRUXELLES, Belgium, 1090 | |
GENT, Belgium, 9000 | |
HUY, Belgium, 4500 | |
Denmark | |
Hørsholm, Denmark, DK-2970 | |
Silkeborg, Denmark, 8600 | |
Herlev, Denmark, 2730 | |
Hellerup, Denmark, 2900 | |
France | |
LILLE CEDEX, France, 59037 | |
AMIENS, France, 80030 | |
NANCY, France, 54037 | |
Germany | |
Berlin, Germany, 14165 | |
Germany, Baden-Württemberg | |
Rheinfelden, Baden-Württemberg, Germany, 79618 | |
Germany, Bayern | |
Fürth, Bayern, Germany, 90766 | |
Garmisch-Partenkirchen, Bayern, Germany, 82467 | |
Germany, Hessen | |
Frankfurt, Hessen, Germany, 65929 | |
Frankfurt, Hessen, Germany, 60528 | |
Germany, Sachsen | |
Dresden, Sachsen, Germany, 01307 | |
Israel | |
Tel Aviv, Israel, 64239 | |
Zerifin, Israel, 70300 | |
Tel Hashomer, Israel, 52621 | |
Haifa, Israel, 31096 | |
Netherlands | |
ZWOLLE, Netherlands, 8025 AB | |
AMERSFOORT, Netherlands, 3818 ES | |
Norway | |
Rjukan, Norway, NO-3660 | |
Notodden, Norway, NO-3675 | |
Oslo, Norway, 0440 | |
Poland | |
Lublin, Poland, 20-090 | |
Lublin, Poland, 20-718 | |
Bialystok, Poland, 15-276 | |
Krakow, Poland, 31-826 | |
Warszawa, Poland, 00-909 | |
Lodz, Poland, 91-425 | |
Gdansk, Poland, 80-742 | |
Sweden | |
Göteborg, Sweden, 416 85 | |
Jönköping, Sweden, 551 85 | |
Kungälv, Sweden, 442 83 | |
United Kingdom, Greater London | |
London, Greater London, United Kingdom, SE5 9RS |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Vital GmbH ( Therapeutic Area Head ) |
Study ID Numbers: | 10942, ODiXaHip |
Study First Received: | February 9, 2009 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00839826 History of Changes |
Health Authority: | Sweden: Medical Products Agency; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Prevention of Thromboembolism after total hip replacement |
Fibrin Modulating Agents Embolism and Thrombosis Anticoagulants Embolism Vascular Diseases Fibrinolytic Agents |
Cardiovascular Agents Antithrombin III Thrombosis Thromboembolism Enoxaparin |
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Thromboembolism |
Thrombosis Pharmacologic Actions Enoxaparin Embolism and Thrombosis Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases |