BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
1 other identifier
interventional
36
1 country
12
Brief Summary
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 atrial-fibrillation
Started Jul 2004
Shorter than P25 for phase_2 atrial-fibrillation
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 24, 2008
CompletedDecember 25, 2014
December 1, 2014
11 months
October 17, 2008
December 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)
Day 14 and 28
Secondary Outcomes (1)
Each category of bleeding events and adverse event
Throughout treatment and followup period
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- years or older
- Japanese male or female
- Non- valvular atrial fibrillation documented by ECG
- Patients aged 60 years and older or with a risk of stroke
You may not qualify if:
- Prior stroke and TIA
- Patients in whom anticoagulants are contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (12)
Unknown Facility
Fukuoka, Fukuoka, 811-0213, Japan
Unknown Facility
Fukuoka, Fukuoka, 814-0180, Japan
Unknown Facility
Kitakyushu, Fukuoka, 800-0057, Japan
Unknown Facility
Koga, Fukuoka, 807-0051, Japan
Unknown Facility
Kurume, Fukuoka, 830-8577, Japan
Unknown Facility
Kitahiroshima, Hokkaido, 061-1134, Japan
Unknown Facility
Amagasaki, Hyōgo, 660-8511, Japan
Unknown Facility
Kawachi-Nagano, Osaka, 586-8521, Japan
Unknown Facility
Osaka, Osaka, 540-0006, Japan
Unknown Facility
Osaka, Osaka, 553-0003, Japan
Unknown Facility
Osaka, Osaka, 558-8558, Japan
Unknown Facility
Suita, Osaka, 565-0871, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2008
First Posted
October 24, 2008
Study Start
July 1, 2004
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
December 25, 2014
Record last verified: 2014-12