DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Edoxaban; Warfarin

Criteria

Inclusion Criteria:

• Male or female subjects 18 to 80 years of age

• Non-valvular AF supported by abnormal ECG documented for two times (interval of more than 1 week) within 6 months prior to randomization.

• CHADS2 Score of at least 1.

Exclusion Criteria:

• Subjects with mitral valve disease

• Subjects with previous valvular heart surgery

• Contraindication for anticoagulants

• Conditions associated with high risk of bleeding

• Acute coronary syndromes (ACS), percutaneous coronary intervention (PCI), MI, stroke, transient ischemic attack (TIA) or coronary artery/cardiac/other major surgery within the previous 30 days

• Active infective endocarditis or life-expectancy < 12 months