drugset / Trial / NCT01516840

Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

NCT01516840

Phase 3 Completed 60 enrolled Bayer Janssen Scientific Affairs, LLC · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.

Timeline

Start
2012-03
Primary completion
2013-12
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Heparin Other / unclassified Intravenous
Subject Rivaroxaban Other / unclassified 15 mg Oral
Comparator Warfarin Small molecule