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BAY59-7939 Japanese in Atrial Fibrillation (2nd)

NCT ID: NCT00973323

Last Updated: 2014-12-30

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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BAY59-7939 Rivaroxaban Non-valvular atrial fibrillation Japanese Patients Phase II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Xarelto (Rivaroxaban, BAY59-7939)

Intervention Type DRUG

2.5mg bid

Arm 2

Group Type EXPERIMENTAL

Xarelto (Rivaroxaban, BAY59-7939)

Intervention Type DRUG

5mg bid

Arm 3

Group Type EXPERIMENTAL

Xarelto (Rivaroxaban, BAY59-7939)

Intervention Type DRUG

10mg bid

Arm 4

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Dose-adjusted warfarin based on target INR values

Interventions

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Xarelto (Rivaroxaban, BAY59-7939)

2.5mg bid

Intervention Type DRUG

Xarelto (Rivaroxaban, BAY59-7939)

5mg bid

Intervention Type DRUG

Xarelto (Rivaroxaban, BAY59-7939)

10mg bid

Intervention Type DRUG

Warfarin

Dose-adjusted warfarin based on target INR values

Intervention Type DRUG

Eligibility Criteria

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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.
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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Fukui-shi, Fukui, Japan

Site Status

Kurume, Fukuoka, Japan

Site Status

Maebaru-chūō, Fukuoka, Japan

Site Status

Kitahiroshima, Hokkaido, Japan

Site Status

Kushiro, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Nomi, Ishikawa-ken, Japan

Site Status

Yokohama, Kanagawa, Japan

Site Status

Ōita, Oita Prefecture, Japan

Site Status

Tokorozawa, Saitama, Japan

Site Status

Countries

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Japan

Other Identifiers

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12024

Identifier Type: -

Identifier Source: org_study_id