BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: October 17, 2008
Last updated: December 23, 2014
Last verified: December 2014
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).

Condition Intervention Phase
Atrial Fibrillation
Drug: Rivaroxaban (BAY59-7939)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R) [ Time Frame: Day 14 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Each category of bleeding events and adverse event [ Time Frame: Throughout treatment and followup period ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: July 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rivaroxaban (BAY59-7939)
10mg BID, Semi-sequential, dose escalation.
Experimental: Arm 2 Drug: Rivaroxaban (BAY59-7939)
20mg BID, Semi-sequential, dose escalation.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00779064

Kitakyushu, Fukuoka, Japan, 800-0057
Kurume, Fukuoka, Japan, 830-8577
Onga, Fukuoka, Japan, 807-0051
Kitahiroshima, Hokkaido, Japan, 061-1134
Amagasaki, Hyogo, Japan, 660-8511
Kawachinagano, Osaka, Japan, 586-8521
Suita, Osaka, Japan, 565-0871
Fukuoka, Japan, 814-0180
Fukuoka, Japan, 811-0213
Osaka, Japan, 558-8558
Osaka, Japan, 540-0006
Osaka, Japan, 553-0003
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00779064     History of Changes
Other Study ID Numbers: 11390 
Study First Received: October 17, 2008
Last Updated: December 23, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Enzyme Inhibitors
Factor Xa Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Serine Proteinase Inhibitors processed this record on May 25, 2016