Status:

COMPLETED

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

Lead Sponsor:

Daiichi Sankyo Co., Ltd.

Conditions:

Atrial Fibrillation

Stroke

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief 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 sub...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2009

Estimated Enrollment :

234 Patients enrolled

Trial Details

Trial ID

NCT00806624

Start Date

October 1 2007

End Date

November 1 2009

Last Update

February 26 2019

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Hong Kong, China

2

Singapore, Singapore

3

Seoul, South Korea

4

Taipei, Taiwan