drugset / Trial / NCT00839163

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

NCT00839163

Phase 2 Completed 613 enrolled Bayer
RandomizedParallel-groupTriple-blindTreatment

Summary

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 and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

Timeline

Start
2004-03
Primary completion
2005-10
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous
Subject Rivaroxaban Other / unclassified 10 mg Oral
Subject Rivaroxaban Other / unclassified 20 mg Oral
Subject Rivaroxaban Other / unclassified 30 mg Oral
Subject Rivaroxaban Other / unclassified 40 mg Oral