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Edoxaban in Japanese NVAF patients with severe renal impairment
NCT01857622Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Jan 2013
- Countries
- 1
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Modality
- Small Molecules
- Drugs
- edoxaban
- Conditions
- Atrial fibrillation (AFib)
01
Overview
Phase 3, open-label trial of edoxaban in Atrial fibrillation (AFib) (3 arms), sponsored by Daiichi Sankyo Co., Ltd. Primary endpoint: Incidence of Any Adjudicated Bleeding Events at 3 months. Started Nov 2011; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
SRI 15mg
DU-176b 15 mg once daily in patients with Severe Renal Impairment.
Normal/MiRI low-dose
DU-176b 30 mg once daily (or 15 mg if adjusted) in patients with Normal/Mild Renal Impairment.
Normal/MiRI high-dose
DU-176b 60 mg once daily (or 30 mg if adjusted) in patients with Normal/Mild Renal Impairment.
03
Who it enrols
Japanese patients with Non-valvular Atrial Fibrillation and either Severe Renal Impairment (CLcr 15-30 mL/min) or Normal/Mild Renal Impairment (CLcr >= 50 mL/min).
04
Endpoints
Primary
Incidence of Any Adjudicated Bleeding Events
Secondary
Plasma concentration of DU-176b
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