Status:
COMPLETED
BAY59-7939 in Atrial Fibrillation Once Daily (OD)
Lead Sponsor:
Bayer
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subje...
Eligibility Criteria
Inclusion
- Japanese subjects with non-valvular AF who met all of the following criteria:
- Male subjects aged 20 years or older and postmenopausal female subjects
- Subjects with 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
- Subjects who were at risk for stroke as follows:
- Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
- Subjects aged 60 years old and above regardless of the existence of above risk factors.
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 :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00973245
Start Date
July 1 2006
End Date
January 1 2007
Last Update
December 30 2014
Active Locations (11)
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1
Chikushino-shi, Fukuoka, Japan, 818-8516
2
Fukuoka, Fukuoka, Japan, 810-8798
3
Nōgata, Fukuoka, Japan, 822-0026
4
Asahikawa, Hokkaido, Japan, 078-8214