Trial Condition(s):
Atrial Fibrillation
BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Bayer Identifier:
12024
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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 described in Japanese).
Inclusion Criteria
- 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 Criteria
- 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Riverside Clinic of Internal Medicine and Cardiology Sapporo, Japan, 064-0807 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tachibanadai Hospital Yokohama, Japan, 227-0046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nakamura Cardiovascular Clinic Maebaru, Japan, 819-1104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hyuga Clinic Kushiro, Japan, 085-0831 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saino Clinic Tokorozawa, Japan, 359-1141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Houju Kinen Hospital Nomi, Japan, 923-1100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tanaka Hospital Fukui, Japan, 910-0005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oita Oka Hospital Oita, Japan, 870-0192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Koyo Clinic Kitahiroshima, Japan, 061-1134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinkoga Hospital Kurume, Japan, 830-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
BAY 59-7939 (Factor Xa inhibitor) Phase II low dose study in patients with atrial fibrillation
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- (Safety) Incidence of bleedingTimeframe: Throughout treatment and followup period
- (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTESTTimeframe: Day 14 and Day 28
Additional Information
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