Trial Condition(s):

Atrial Fibrillation

BAY59-7939 in Atrial Fibrillation Once daily (OD)

Bayer Identifier:

11866

ClinicalTrials.gov Identifier:

NCT00973245

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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.

Trial Summary

Enrollment Goal
102
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

Kihara Cardiovascular and Internal Hospital

Asahikawa, Japan, 078-8214

Status
Completed
 
Locations

Saino Clinic

Tokorozawa, Japan, 359-1141

Status
Completed
 
Locations

Kuwana City Hospital-Branch Hospital

Kuwana, Japan, 511-0068

Status
Completed
 
Locations

Kobe Red Cross Hospital

Kobe, Japan, 651-0073

Status
Completed
 
Locations

Fukuoka Postal Services Agency Hospital

Fukuoka, Japan, 810-8798

Status
Completed
 
Locations

Saiseikai Futsukaichi Hospital

Chikushino, Japan, 818-8516

Status
Completed
 
Locations

Tohoku Kosai Hospital

Sendai, Japan, 980-0803

Status
Completed
 
Locations

Dobashi Medical Clinic

Sendai, Japan, 980-0871

Status
Completed
 
Locations

Tokyo Heart Center

Shinagawa-ku, Japan, 141-0001

Status
Completed
 
Locations

Takarazuka Hospital

Takarazuka, Japan, 665-0022

Status
Completed
 
Locations

Nishio Hospital

Nogata, Japan, 822-0026

Status
Completed
 

Trial Design