Back to resultsBAY59-7939 Japanese in Atrial Fibrillation (2nd)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Xarelto (Rivaroxaban, BAY59-7939)
Xarelto (Rivaroxaban, BAY59-7939)
Xarelto (Rivaroxaban, BAY59-7939)
Warfarin
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
(Safety) Incidence of bleeding
(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00973323
Brief Title
BAY59-7939 Japanese in Atrial Fibrillation (2nd)
Official Title
BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
2.5mg bid
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
5mg bid
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
10mg bid
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Dose-adjusted warfarin based on target INR values
Primary Outcome Measure Information:
Title
(Safety) Incidence of bleeding
Time Frame
Throughout treatment and followup period
Title
(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
Time Frame
Day 14 and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-8577
Country
Japan
City
Maebaru
State/Province
Fukuoka
ZIP/Postal Code
819-1104
Country
Japan
City
Kitahiroshima
State/Province
Hokkaido
ZIP/Postal Code
061-1134
Country
Japan
City
Kushiro
State/Province
Hokkaido
ZIP/Postal Code
085-0831
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0807
Country
Japan
City
Nomi
State/Province
Ishikawa
ZIP/Postal Code
923-1100
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
227-0046
Country
Japan
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1141
Country
Japan
City
Fukui
ZIP/Postal Code
910-0005
Country
Japan
City
Oita
ZIP/Postal Code
870-0192
Country
Japan
12. IPD Sharing Statement
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BAY59-7939 Japanese in Atrial Fibrillation (2nd)
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