FindTrial
Sign In

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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221674
Enrollment
90
Registered
2011-12-15
Start date
2011-12-15
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

Non-valvular 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
in subjects who have any dose adjustment factor (body weight of =<60 kg or the presence of concurrent treatment with quinidine or verapamil), DU-176b will be orally administered at a dose of 15 mg onc
in subjects who have any dose adjustment factor (body weight of =<60 kg or the presence of concurrent treatment with quinidine or verapamil), DU-176b will be orally administered at a dose of 30 mg onc

Sponsors

DAIICHI SANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with non-valvular atrial fibrillation and severe renal impairment, or normal renal function or mild renal impairment

Exclusion criteria

Exclusion criteria: -Patients on hemodialysis or patients who may start hemodialysis before the follow-up assessment -Patients at risk for bleeding -Patients who are receiving treatment with any anticoagulant drugs excluding warfarin and dabigatran -Patients with evidence of hepatic dysfunction

Design outcomes

Primary

MeasureTime frame
Safety endpoints[Incidence of all bleeding events, adverse events and adverse drug reactions]—

Outcome results

None listed

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