Trial Condition(s):
Atrial Fibrillation
BAY59-7939, Japanese phase II in Atrial FibrillationTrial Status
Bayer Identifier:
11390
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).
Inclusion Criteria
- 20 years or older - Japanese male or female - Non- valvular atrial fibrillation documented by ECG - Patients aged 60 years and older or with a risk of stroke
Exclusion Criteria
- Prior stroke and TIA - Patients in whom anticoagulants are contraindicated
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Osaka, Japan, 540-0006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitakyushu, Japan, 800-0057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Onga, Japan, 807-0051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kurume, Japan, 830-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitahiroshima, Japan, 061-1134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amagasaki, Japan, 660-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 553-0003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 811-0213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 814-0180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
BAY59-7939, Japanese phase II in Atrial FibrillationTrial Status
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)Timeframe: Day 14 and 28
Secondary Outcome
- Each category of bleeding events and adverse eventTimeframe: Throughout treatment and followup period
Additional Information
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