Trial Condition(s):
Atrial Fibrillation
BAY59-7939 in Atrial Fibrillation Once daily (OD)
Bayer Identifier:
11866
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Kihara Cardiovascular and Internal Hospital Asahikawa, Japan, 078-8214 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saino Clinic Tokorozawa, Japan, 359-1141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kuwana City Hospital-Branch Hospital Kuwana, Japan, 511-0068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kobe Red Cross Hospital Kobe, Japan, 651-0073 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fukuoka Postal Services Agency Hospital Fukuoka, Japan, 810-8798 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saiseikai Futsukaichi Hospital Chikushino, Japan, 818-8516 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tohoku Kosai Hospital Sendai, Japan, 980-0803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dobashi Medical Clinic Sendai, Japan, 980-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Heart Center Shinagawa-ku, Japan, 141-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Takarazuka Hospital Takarazuka, Japan, 665-0022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nishio Hospital Nogata, Japan, 822-0026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
BAY 59-7939 (Factor Xa inhibitor) Phase II once daily dose study in patients with atrial fibrillation
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- (Safety) Incidence of bleedingTimeframe: Throughout treatment and followup period
- (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTESTTimeframe: Day 14 and Day 28
Additional Information
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