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

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Withdrawn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Withdrawn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
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    Safety Issue:
    No

Secondary Outcome

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

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