check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

11390

ClinicalTrials.gov Identifier:

NCT00779064

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY59-7939, Japanese phase II in Atrial FibrillationTrial Status

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).

Key Participants Requirements

Sex

Both

Age

20 Years

  • - 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

  • - Prior stroke and TIA
    - Patients in whom anticoagulants are contraindicated

Trial summary

Enrollment Goal
36
Trial Dates
July 2004 - June 2005
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Osaka, 540-0006, Japan
Completed
Osaka, 558-8558, Japan
Withdrawn
Kawachinagano, 586-8521, Japan
Completed
Kitakyushu, 800-0057, Japan
Completed
Onga, 807-0051, Japan
Completed
Kurume, 830-8577, Japan
Completed
Kitahiroshima, 061-1134, Japan
Completed
Suita, 565-0871, Japan
Completed
Amagasaki, 660-8511, Japan
Completed
Osaka, 553-0003, Japan
Completed
Fukuoka, 811-0213, Japan
Completed
Fukuoka, 814-0180, Japan
Withdrawn
Sakai, 591-8025, Japan

Primary Outcome

  • Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)
    date_rangeTime Frame:
    Day 14 and 28
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Each category of bleeding events and adverse event
    date_rangeTime Frame:
    Throughout treatment and followup period
    enhanced_encryption
    Safety Issue:
    yes

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.