BAY59-7939 in Atrial Fibrillation Once Daily (OD)
Phase 2
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT00973245
- Lead Sponsor
- Bayer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Xarelto (Rivaroxaban, BAY59-7939) - Arm 2 Xarelto (Rivaroxaban, BAY59-7939) - Arm 3 Xarelto (Rivaroxaban, BAY59-7939) - Arm 4 Warfarin -
- 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