BAY59-7939 in Atrial Fibrillation Once Daily (OD)

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 8, 2009
Last updated: December 26, 2014
Last verified: December 2014
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 Intervention Phase
Atrial Fibrillation
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Warfarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by Bayer:

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

Enrollment: 102
Study Start Date: July 2006
Study Completion Date: January 2007
Arms Assigned Interventions
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


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

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.
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Please refer to this study by its identifier: NCT00973245

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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00973245     History of Changes
Other Study ID Numbers: 11866 
Study First Received: September 8, 2009
Last Updated: December 26, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Non-valvular atrial fibrillation
Japanese Patients
Phase II

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Enzyme Inhibitors
Factor Xa Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Serine Proteinase Inhibitors processed this record on May 23, 2016