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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00402467 |
The study drug, BAY 59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells). It is available as a tablet. 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. In this study 4 different doses of the investigational drug BAY 59-7939 will be tested in comparison to Enoxaparin. You will receive during the study either one of the following BAY 59-7939 treatments or Enoxaparin. The following doses of BAY 59-7939 will be tested: Dose I ; Dose II, Dose III, Dose IV. This study will run for approximately 7 months in a number of countries. In total, up to 600 patients may participate in this study.
Condition | Intervention | Phase |
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Thromboembolism |
Drug: Rivaroxaban (BAY59-7939) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Related to medical history:
Related to current symptoms or findings:
Related to current treatment:
Miscellaneous:
Removal of Subjects from Study:
A subject who withdraws is one who discontinued a clinical study for any reason.
Subjects may be withdrawn from the study for the following reasons:
United States, Alabama | |
Bayer Clinical Research Center | |
Birmingham, Alabama, United States, 35205 | |
United States, Arizona | |
Bayer Clinical Research Center | |
Phoenix, Arizona, United States, 85023 | |
Bayer Clinical Research Center | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Bayer Clinical Research Center | |
La Mesa, California, United States, 91942-3019 | |
Bayer Clinical Research Center | |
Torrance, California, United States, 90502-2004 | |
United States, Colorado | |
Bayer Clinical Research Center | |
Aurora, Colorado, United States, 80011-6798 | |
Bayer Clinical Research Center | |
Aurora, Colorado, United States, 80012 | |
United States, Florida | |
Bayer Clinical Research Center | |
St. Petersburg, Florida, United States, 33703 | |
Bayer Clinical Research Center | |
St. Petersburg, Florida, United States, 33703 | |
Bayer Clinical Research Center | |
Sarasota, Florida, United States, 34239 | |
Bayer Clinical Research Center | |
Palm Beach Gardens, Florida, United States, 33410 | |
Bayer Clinical Research Center | |
Jacksonville, Florida, United States, 32216 | |
United States, Georgia | |
Bayer Clinical Research Center | |
Decatur, Georgia, United States, 30033 | |
United States, Ohio | |
Bayer Clinical Research Center | |
Cincinnati, Ohio, United States, 45219 | |
United States, Texas | |
Bayer Clinical Research Center | |
Lubbock, Texas, United States, 79410 | |
Bayer Clinical Research Center | |
Dallas, Texas, United States, 75231 | |
Canada | |
Bayer Clinical Research Center | |
ask Central Contact, Canada |
Study ID Numbers: | 10945 |
Study First Received: | November 21, 2006 |
Last Updated: | November 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00402467 |
Health Authority: | United States: Food and Drug Administration |
Prevention of venous thromboembolism |
Embolism and Thrombosis Embolism Vascular Diseases Venous Thromboembolism |
Antithrombin III Thrombosis Thromboembolism |
Cardiovascular Diseases |