check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

12024

ClinicalTrials.gov Identifier:

NCT00973323

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

Both

Age

20 Years
  • - Japanese subjects with non-valvular AF who met all of the following criteria:
     -- 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
     -- Male subjects aged 20 years or older and postmenopausal female subjects
     -- Subjects with at least one risk factor for thromboembolism or aged 60 years or older (Risk factor for thromboembolism: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
  • - 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
100
Trial Dates
September 2005 - March 2006
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Riverside Clinic of Internal Medicine and CardiologySapporo, 064-0807, Japan
Completed
Tachibanadai HospitalYokohama, 227-0046, Japan
Completed
Nakamura Cardiovascular ClinicMaebaru, 819-1104, Japan
Completed
Hyuga ClinicKushiro, 085-0831, Japan
Completed
Saino ClinicTokorozawa, 359-1141, Japan
Completed
Houju Kinen HospitalNomi, 923-1100, Japan
Completed
Tanaka HospitalFukui, 910-0005, Japan
Completed
Oita Oka HospitalOita, 870-0192, Japan
Completed
Koyo ClinicKitahiroshima, 061-1134, Japan
Completed
Shinkoga HospitalKurume, 830-8577, Japan

Primary Outcome

  • (Safety) Incidence of bleeding
    date_rangeTime Frame:
    Throughout treatment and followup period
    enhanced_encryption
    Safety Issue:
    yes
  • (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
    date_rangeTime Frame:
    Day 14 and Day 28
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

BAY 59-7939 (Factor Xa inhibitor) Phase II low 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

Additional Information

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