BAY59-7939 in Atrial Fibrillation Once Daily (OD)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00973245
First received: September 8, 2009
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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: 114
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

  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:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00973245

Locations
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, 980-0871
Sendai, Miyagi, Japan, 980-0803
Tokorozawa, Saitama, Japan, 359-1141
Shinagawa-ku, Tokyo, Japan, 141-0001
Fukuoka, Japan, 810-8798
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: NCT00973245     History of Changes
Other Study ID Numbers: 11866
Study First Received: September 8, 2009
Last Updated: June 16, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
BAY 59-7939
Rivaroxaban
Non-valvular atrial fibrillation
Japanese Patients
Phase II

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

ClinicalTrials.gov processed this record on August 21, 2014