check_circleStudy Completed
Atrial fibrillation
Bayer Identifier:
12024
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Trial purpose
This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).
Key Participants Requirements
Sex
BothAge
20 YearsTrial summary
Enrollment Goal
100Trial Dates
September 2005 - March 2006Phase
Phase 2Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Riverside Clinic of Internal Medicine and Cardiology | Sapporo, 064-0807, Japan |
Completed | Tachibanadai Hospital | Yokohama, 227-0046, Japan |
Completed | Nakamura Cardiovascular Clinic | Maebaru, 819-1104, Japan |
Completed | Hyuga Clinic | Kushiro, 085-0831, Japan |
Completed | Saino Clinic | Tokorozawa, 359-1141, Japan |
Completed | Houju Kinen Hospital | Nomi, 923-1100, Japan |
Completed | Tanaka Hospital | Fukui, 910-0005, Japan |
Completed | Oita Oka Hospital | Oita, 870-0192, Japan |
Completed | Koyo Clinic | Kitahiroshima, 061-1134, Japan |
Completed | Shinkoga Hospital | Kurume, 830-8577, Japan |
Primary Outcome
- (Safety) Incidence of bleedingdate_rangeTime Frame:Throughout treatment and followup periodenhanced_encryptionyesSafety Issue:
- (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTESTdate_rangeTime Frame:Day 14 and Day 28enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
4