drugset / Trial / NCT00829933

Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation

NCT00829933

Phase 2 Completed 536 enrolled Daiichi Sankyo
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.

Timeline

Start
2007-03
Primary completion
2008-07
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Edoxaban Small molecule
Comparator Warfarin Small molecule

Indications