BAY59-7939 Japanese in Atrial Fibrillation (2nd)

BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation

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.