Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis ODIXa-DVT A prospective, randomized, multinational, multicenter, partially blinded, parallel-group, open-label active comparator controlled phase II Dose Finding and Proof of Principle Trial

Femme et Homme

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Extrait

The objectives of this Phase II dose finding trial are to assess the efficacy and safety of BAY 59-7939 for the treatment of acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound - CCUS) in male and female patients aged 18 years or above. Patients with symptomatic pulmonary embolism at study entry will be excluded. Pharmacokinetic and pharmacodynamic parameters (incl, activated partial thrombin time (aPTT), prothrombin time (PT, INR) Factor Xa activity and Heptest) will also be assessed

Critère d'inclusion

Acute deep vein thrombosis

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Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis ODIXa-DVT A prospective, randomized, multinational, multicenter, partially blinded, parallel-group, ...