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The study drug, BAY59-7939, 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 BAY59-7939 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 BAY59-7939 will be tested in comparison to Enoxaparin. You will receive during the study either one of the following BAY59-7939 treatments or Enoxaparin. The following doses of BAY59-7939 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.
Enrollment
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Inclusion criteria
Exclusion criteria
Related to medical history:
Related to current symptoms or findings:
Heart insufficiency NYHA III-IV
Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits)including patients with acquired or congenital thrombophilia
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Subjects may be withdrawn from the study for the following reasons:
Primary purpose
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613 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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