Atrial Fibrillation
Conditions
Keywords
BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II
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 subjects with non-valvular atrial fibrillation (originally described in Japanese).
Interventions
10mg od
DRUGWarfarin
Dose-adjusted warfarin based on target INR values
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Safety) Incidence of bleeding | Throughout treatment and followup period |
| (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST | Day 14 and Day 28 |
Countries
Japan
Outcome results
None listed