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BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

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ClinicalTrials.gov Identifier: NCT00779064
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Rivaroxaban (BAY59-7939) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
Study Start Date : July 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R) [ Time Frame: Day 14 and 28 ]

Secondary Outcome Measures :
  1. Each category of bleeding events and adverse event [ Time Frame: Throughout treatment and followup period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 540-0006
Osaka, Japan, 553-0003
Osaka, Japan, 558-8558
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00779064     History of Changes
Other Study ID Numbers: 11390
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants