CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 536 enrolled
Drug / intervention
DU-176b tablets +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00829933
NCT00829933Phase 2Completed
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A Randomized Dose-ranging Controlled Trial of DU-176b Versus Warfarin Potassium in Patients With Non-valvular Atrial Fibrillation

Daiichi Sankyo Co., Ltd.·interventional·Posted Jan 27, 2009·Updated Feb 25, 2019

In Brief

A Phase 2 clinical trial evaluating DU-176b tablets and Warfarin potassium tablets for Atrial Fibrillation. Completed, enrolled 536 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2009
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago

Interventions

DU-176b tabletsdrug

DU-176b tablets taken once daily for up to 12 weeks

Warfarin potassium tabletsdrug

Warfarin potassium tablets taken once daily for up to 12 weeks