CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 93 enrolled
Drug / intervention
DU-176b 15mg +2 moredrug
Likely dose
DU-176b 15mgfrom 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/NCT01857622
NCT01857622Phase 3Completed
CompareCT.gov

Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)

Daiichi Sankyo Co., Ltd.·interventional·Posted May 20, 2013·Updated Mar 5, 2019

In Brief

A Phase 3 clinical trial evaluating DU-176b 15mg, DU-176b 30mg, and 1 other intervention for Non-valvular Atrial Fibrillation. Completed, enrolled 93 participants across 1 site.

Detailed Summary

To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-valvular Atrial Fibrillation
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 20, 2013
Enrollment StartNov 1, 2011
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.1 years ago

Interventions

DU-176b 15mgdrug

oral DU-176b 15mg once daily

DU-176b 30mgdrug

oral DU-176b 30mg once daily

DU-176b 60mgdrug

oral DU-176b 60mg once daily