BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00779064

Enrollment

Registered

2008-10-24

Start date

2004-07-31

Completion date

2005-06-30

Last updated

2014-12-25

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

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Brief summary

This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).

Interventions

DRUGRivaroxaban (BAY59-7939)

10mg BID, Semi-sequential, dose escalation.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* 20 years or older * Japanese male or female * Non- valvular atrial fibrillation documented by ECG * Patients aged 60 years and older or with a risk of stroke

Exclusion criteria

* Prior stroke and TIA * Patients in whom anticoagulants are contraindicated

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)	Day 14 and 28

Secondary

Measure	Time frame
Each category of bleeding events and adverse event	Throughout treatment and followup period

Countries

Japan

Outcome results

None listed

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