Back to resultsBAY59-7939 in Atrial Fibrillation Once Daily (OD)
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:
- Male subjects aged 20 years or older and postmenopausal female subjects
- Subjects with 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
- Subjects who were at risk for stroke as follows:
- Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
- Subjects aged 60 years old and above regardless of the existence of above risk factors.
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
Active Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm 4
Arm 3
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
NCT00973245
Brief Title
BAY59-7939 in Atrial Fibrillation Once Daily (OD)
Official Title
BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily 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
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (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 is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (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
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
10mg od
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
15mg od
Intervention Type
Drug
Intervention Name(s)
Xarelto (Rivaroxaban, BAY59-7939)
Intervention Description
20mg od
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:
Male subjects aged 20 years or older and postmenopausal female subjects
Subjects with 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
Subjects who were at risk for stroke as follows:
Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
Subjects aged 60 years old and above regardless of the existence of above risk factors.
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
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8516
Country
Japan
City
Nogata
State/Province
Fukuoka
ZIP/Postal Code
822-0026
Country
Japan
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8214
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
651-0073
Country
Japan
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
665-0022
Country
Japan
City
Kuwana
State/Province
Mie
ZIP/Postal Code
511-0068
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0803
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0871
Country
Japan
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1141
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0001
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-8798
Country
Japan
12. IPD Sharing Statement
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BAY59-7939 in Atrial Fibrillation Once Daily (OD)
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