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BAY59-7939 in Atrial Fibrillation Once Daily (OD)

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ClinicalTrials.gov Identifier: NCT00973245
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation
Study Start Date : July 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Arm 1 Drug: Xarelto (Rivaroxaban, BAY59-7939)
10mg od

Experimental: Arm 2 Drug: Xarelto (Rivaroxaban, BAY59-7939)
15mg od

Active Comparator: Arm 4 Drug: Warfarin
Dose-adjusted warfarin based on target INR values

Experimental: Arm 3 Drug: Xarelto (Rivaroxaban, BAY59-7939)
20mg od




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 ]


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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:

  • Male subjects aged 20 years or older and postmenopausal female subjects
  • Subjects with 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
  • Subjects who were at risk for stroke as follows:
  • Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
  • Subjects aged 60 years old and above regardless of the existence of above risk factors.

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.

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): NCT00973245


Locations
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Japan
Chikushino, Fukuoka, Japan, 818-8516
Nogata, Fukuoka, Japan, 822-0026
Asahikawa, Hokkaido, Japan, 078-8214
Kobe, Hyogo, Japan, 651-0073
Takarazuka, Hyogo, Japan, 665-0022
Kuwana, Mie, Japan, 511-0068
Sendai, Miyagi, Japan, 980-0803
Sendai, Miyagi, Japan, 980-0871
Tokorozawa, Saitama, Japan, 359-1141
Shinagawa-ku, Tokyo, Japan, 141-0001
Fukuoka, Japan, 810-8798
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00973245    
Other Study ID Numbers: 11866
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