BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

NCT ID: NCT00779064

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-06-30

Brief Summary

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This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Rivaroxaban (BAY59-7939)

Intervention Type DRUG

10mg BID, Semi-sequential, dose escalation.

Arm 2

Group Type EXPERIMENTAL

Rivaroxaban (BAY59-7939)

Intervention Type DRUG

20mg BID, Semi-sequential, dose escalation.

Interventions

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Rivaroxaban (BAY59-7939)

10mg BID, Semi-sequential, dose escalation.

Intervention Type DRUG

Rivaroxaban (BAY59-7939)

20mg BID, Semi-sequential, dose escalation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20 years or older
* Japanese male or female
* Non- valvular atrial fibrillation documented by ECG
* Patients aged 60 years and older or with a risk of stroke

Exclusion Criteria

* Prior stroke and TIA
* Patients in whom anticoagulants are contraindicated
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Fukuoka, Fukuoka, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Kitakyushu, Fukuoka, Japan

Site Status

Koga, Fukuoka, Japan

Site Status

Kurume, Fukuoka, Japan

Site Status

Kitahiroshima, Hokkaido, Japan

Site Status

Amagasaki, Hyōgo, Japan

Site Status

Kawachi-Nagano, Osaka, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Suita, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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11390

Identifier Type: -

Identifier Source: org_study_id