BAY59-7939 Japanese in Atrial Fibrillation (2nd)

December 26, 2014 updated by: Bayer

BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukui, Japan, 910-0005
      • Oita, Japan, 870-0192
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-8577
      • Maebaru, Fukuoka, Japan, 819-1104
    • Hokkaido
      • Kitahiroshima, Hokkaido, Japan, 061-1134
      • Kushiro, Hokkaido, Japan, 085-0831
      • Sapporo, Hokkaido, Japan, 064-0807
    • Ishikawa
      • Nomi, Ishikawa, Japan, 923-1100
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 227-0046
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-1141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 7, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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