BAY59-7939 Japanese in Atrial Fibrillation (2nd)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00973323
First received: September 7, 2009
Last updated: April 19, 2010
Last verified: April 2010
  Purpose

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 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 Low 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: 121
Study Start Date: September 2005
Study Completion Date: March 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973323

Locations
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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Yakuhin
ClinicalTrials.gov Identifier: NCT00973323     History of Changes
Other Study ID Numbers: 12024
Study First Received: September 7, 2009
Last Updated: April 19, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
BAY59-7939
Rivaroxaban
Non-valvular atrial fibrillation
Japanese Patients
Phase II

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014