Status:
COMPLETED
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) ...
Eligibility Criteria
Inclusion
- Subjects are eligible for the study if all of the following apply:
- Subject has paroxysmal permanent or persistent NVAF
- Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
- Legal minimum age requirement (country-specific).
- Written informed consent has been obtained.
Exclusion
- History of heart valve disorders
- History of rheumatic fever.
- History of stroke and/or systemic embolism (including TIA).
- History of Acute Coronary Syndrome (ACS).
- Indication for warfarin other than NVAF.
- Known hemorrhagic disorder and/or coagulation disorder.
- Active bleeding or any condition associated with increased risk of bleeding.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00448214
Start Date
March 1 2007
End Date
October 1 2008
Last Update
December 19 2011
Active Locations (18)
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1
Launceston, Australia
2
Pok Fu Lam, Hong Kong
3
Shatin, Hong Kong
4
Hokkaido, Japan