Status:
COMPLETED
BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Lead Sponsor:
Bayer
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally desc...
Eligibility Criteria
Inclusion
- Japanese subjects with non-valvular AF who met all of the following criteria:
- Persistent or paroxysmal non-valvular AF with \>/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
- Male subjects aged 20 years or older and postmenopausal female subjects
- Subjects with at least one risk factor for thromboembolism or aged 60 years or older (Risk factor for thromboembolism: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
Exclusion
- History or presence of stroke or transient ischemic attack.
- History of intracerebral hemorrhage.
- History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00973323
Start Date
September 1 2005
End Date
March 1 2006
Last Update
December 30 2014
Active Locations (10)
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1
Fukui-shi, Fukui, Japan, 910-0005
2
Kurume, Fukuoka, Japan, 830-8577
3
Maebaru-chūō, Fukuoka, Japan, 819-1104
4
Kitahiroshima, Hokkaido, Japan, 061-1134