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BAY59-7939 Japanese in Atrial Fibrillation (2nd)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00973323
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation
Study Start Date : September 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Xarelto (Rivaroxaban, BAY59-7939)
2.5mg bid
Experimental: Arm 2 Drug: Xarelto (Rivaroxaban, BAY59-7939)
5mg bid
Experimental: Arm 3 Drug: Xarelto (Rivaroxaban, BAY59-7939)
10mg bid
Active Comparator: Arm 4 Drug: Warfarin
Dose-adjusted warfarin based on target INR values


Outcome Measures
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Primary Outcome Measures :
  1. (Safety) Incidence of bleeding [ Time Frame: Throughout treatment and followup period ]
  2. (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST [ Time Frame: Day 14 and Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese subjects with non-valvular AF who met all of the following criteria:

    • Persistent or paroxysmal non-valvular AF with >/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
    • Male subjects aged 20 years or older and postmenopausal female subjects
    • Subjects with at least one risk factor for thromboembolism or aged 60 years or older (Risk factor for thromboembolism: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).

Exclusion Criteria:

  • History or presence of stroke or transient ischemic attack.
  • History of intracerebral hemorrhage.
  • History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.
Contacts and Locations
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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): NCT00973323


Locations
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Japan
Kurume, Fukuoka, Japan, 830-8577
Maebaru, Fukuoka, Japan, 819-1104
Kitahiroshima, Hokkaido, Japan, 061-1134
Kushiro, Hokkaido, Japan, 085-0831
Sapporo, Hokkaido, Japan, 064-0807
Nomi, Ishikawa, Japan, 923-1100
Yokohama, Kanagawa, Japan, 227-0046
Tokorozawa, Saitama, Japan, 359-1141
Fukui, Japan, 910-0005
Oita, Japan, 870-0192
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00973323    
Other Study ID Numbers: 12024
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Bayer:
BAY59-7939
Rivaroxaban
Non-valvular atrial fibrillation
Japanese Patients
Phase II
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Rivaroxaban
 Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action