BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Phase 2
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT00973323
- Lead Sponsor
- Bayer
- 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 described in Japanese).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 4 Warfarin - Arm 3 Xarelto (Rivaroxaban, BAY59-7939) - Arm 1 Xarelto (Rivaroxaban, BAY59-7939) - Arm 2 Xarelto (Rivaroxaban, BAY59-7939) -
- Primary Outcome Measures
Name Time Method (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
- Secondary Outcome Measures
Name Time Method