MedDataX Logo

BAY59-7939 in Atrial Fibrillation Once Daily (OD)

NCT ID: NCT00973245

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

Xarelto (Rivaroxaban, BAY59-7939)

Intervention Type DRUG

10mg od

Arm 2

Group Type EXPERIMENTAL

Xarelto (Rivaroxaban, BAY59-7939)

Intervention Type DRUG

15mg od

Arm 4

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Dose-adjusted warfarin based on target INR values

Arm 3

Group Type EXPERIMENTAL

Xarelto (Rivaroxaban, BAY59-7939)

Intervention Type DRUG

20mg od

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Xarelto (Rivaroxaban, BAY59-7939)

10mg od

Intervention Type DRUG

Xarelto (Rivaroxaban, BAY59-7939)

15mg od

Intervention Type DRUG

Xarelto (Rivaroxaban, BAY59-7939)

20mg od

Intervention Type DRUG

Warfarin

Dose-adjusted warfarin based on target INR values

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chikushino-shi, Fukuoka, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Nōgata, Fukuoka, Japan

Site Status

Asahikawa, Hokkaido, Japan

Site Status

Kobe, Hyōgo, Japan

Site Status

Takarazuka, Hyōgo, Japan

Site Status

Kuwana, Mie-ken, Japan

Site Status

Sendai, Miyagi, Japan

Site Status

Sendai, Miyagi, Japan

Site Status

Tokorozawa, Saitama, Japan

Site Status

Shinagawa-ku, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11866

Identifier Type: -

Identifier Source: org_study_id