A Phase 3, randomized, double-blind, double-dummy, parallel group, multi-center, multi-national study for evaluation of efficacy and safety of DU-176b versus warfarin in subjects with atrial fibrillation

A Phase 3, randomized, double-blind, double-dummy, parallel group, multi-center, multi-national study for evaluation of efficacy and safety of DU-176b versus warfarin in subjects with atrial fibrillation - Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation (ENGAGE AF-TIMI 48)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220747

Enrollment

20500

Registered

2009-06-12

Start date

2009-06-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with atrial fibrillation

Interventions

investigational material(s) Generic name etc : DU-176b INN of investigational material : edoxaban Therapeutic category code : 333 Anticoagulants Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Documented AF on ECG

Exclusion criteria

Exclusion criteria: - Subjects with any contraindication for anticoagulant agents - Subjects with conditions associated with high risk of bleeding - Females of childbearing potential

Design outcomes

Primary

Measure	Time frame
The composite primary endpoint of stroke and systemic embolic events.	—

Secondary

Measure	Time frame
- The composite clinical outcome of stroke, SEE, and all-cause mortality. - Major bleeding events	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026