Trial Condition(s):

Atrial Fibrillation

BAY59-7939 Japanese in Atrial Fibrillation (2nd)

Bayer Identifier:

12024

ClinicalTrials.gov Identifier:

NCT00973323

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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.

Trial Summary

Enrollment Goal
100
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Riverside Clinic of Internal Medicine and Cardiology

Sapporo, Japan, 064-0807

Status
Completed
 
Locations

Tachibanadai Hospital

Yokohama, Japan, 227-0046

Status
Completed
 
Locations

Nakamura Cardiovascular Clinic

Maebaru, Japan, 819-1104

Status
Completed
 
Locations

Hyuga Clinic

Kushiro, Japan, 085-0831

Status
Completed
 
Locations

Saino Clinic

Tokorozawa, Japan, 359-1141

Status
Completed
 
Locations

Houju Kinen Hospital

Nomi, Japan, 923-1100

Status
Completed
 
Locations

Tanaka Hospital

Fukui, Japan, 910-0005

Status
Completed
 
Locations

Oita Oka Hospital

Oita, Japan, 870-0192

Status
Completed
 
Locations

Koyo Clinic

Kitahiroshima, Japan, 061-1134

Status
Completed
 
Locations

Shinkoga Hospital

Kurume, Japan, 830-8577

Status
Completed
 

Trial Design