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
  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:


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:
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 April 16, 2014