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BAY59-7939, Japanese Phase II in Atrial Fibrillation Trial Status

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00779064
First received: October 17, 2008
Last updated: October 23, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Fibrillation Trial Status

Resource links provided by NLM:

Drug Information available for: Rivaroxaban
U.S. FDA Resources

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: 57
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779064

Locations
Japan
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, 811-0213
Fukuoka, Japan, 814-0180
Osaka, Japan, 558-8558
Osaka, Japan, 553-0003
Osaka, Japan, 540-0006
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Yakuhin LTD
ClinicalTrials.gov Identifier: NCT00779064     History of Changes
Other Study ID Numbers: 11390
Study First Received: October 17, 2008
Last Updated: October 23, 2008
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013