Trial Condition(s):

Atrial Fibrillation

BAY59-7939 in Atrial Fibrillation Once daily (OD)

Bayer Identifier:

11866

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT 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
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Phase
2
Could I receive a placebo?
No
Products
N/A
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Investigative Site

Asahikawa, Japan, 078-8214

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Investigative Site

Tokorozawa, Japan, 359-1141

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Investigative Site

Kuwana, Japan, 511-0068

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Investigative Site

Kobe, Japan, 651-0073

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Investigative Site

Fukuoka, Japan, 810-8798

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Investigative Site

Chikushino, Japan, 818-8516

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Investigative Site

Sendai, Japan, 980-0803

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Investigative Site

Sendai, Japan, 980-0871

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Investigative Site

Shinagawa-ku, Japan, 141-0001

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Investigative Site

Takarazuka, Japan, 665-0022

Locations

Investigative Site

Nogata, Japan, 822-0026

Trial Design