BAY59-7939 Japanese in Atrial Fibrillation (2nd)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00973323

Enrollment

100

Registered

2009-09-09

Start date

2005-09-30

Completion date

2006-03-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II

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).

Interventions

DRUGXarelto (Rivaroxaban, BAY59-7939)

2.5mg bid

DRUGWarfarin

Dose-adjusted warfarin based on target INR values

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026