At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 984 enrolled
Drug / intervention
Du-176b +1 moredrug
Likely dose
Du-176b 15 mgfrom 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.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of DU-176b in Patients With NVAF Aged 80 Years or Older Who Are Ineligible for Available Oral Anticoagulation Therapy
In Brief
A Phase 3 clinical trial evaluating Du-176b and placebo for Atrial Fibrillation. Completed, enrolled 984 participants across 164 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartAug 2016
Primary CompletionDec 2019
TodayJul 2026
First PostedJun 16, 2016
Enrollment StartAug 5, 2016
Primary CompletionDec 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.0 years ago
Interventions
Du-176bdrug
DU-176b orally administered at a dose of 15 mg once daily.
placebodrug
Placebo orally administered once daily.