Atrial FibrillationPhase 2NCT00973245
BAY59-7939 in Atrial Fibrillation Once Daily (OD)
A Phase 2 study testing Xarelto (Rivaroxaban, BAY59-7939) and Warfarin in people with Atrial Fibrillation, run by Bayer at 11 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Xarelto (Rivaroxaban, BAY59-7939) and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 11 sitesJapan
- Study dates
- Jul 2006to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Study site
Asahikawa, Hokkaido, 078-8214
Study site
Chikushino-shi, Fukuoka, 818-8516
Study site
Fukuoka, Fukuoka, 810-8798
Study site
Kobe, Hyōgo, 651-0073
Study site
Kuwana, Mie-ken, 511-0068
Study site
Nōgata, Fukuoka, 822-0026
Study site
Sendai, Miyagi, 980-0803
Study site
Sendai, Miyagi, 980-0871
Study site
Shinagawa-ku, Tokyo, 141-0001
Study site
Takarazuka, Hyōgo, 665-0022
Study site
Tokorozawa, Saitama, 359-1141
About this study
Official title: BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation
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).
- Conditions
- Atrial Fibrillation
- Being tested
- Xarelto (Rivaroxaban, BAY59-7939), Warfarin
- Keywords
- BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xarelto (Rivaroxaban, BAY59-7939)Drug
10mg od
Xarelto (Rivaroxaban, BAY59-7939)Drug
15mg od
Xarelto (Rivaroxaban, BAY59-7939)Drug
20mg od
WarfarinDrug
Dose-adjusted warfarin based on target INR values
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939) |
| Arm 2 | Experimental | Not described Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939) |
| Arm 4 | Active comparator | Not described Receives: Drug: Warfarin |
| Arm 3 | Experimental | Not described Receives: Drug: Xarelto (Rivaroxaban, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Safety) Incidence of bleeding
Measured: Throughout treatment and followup period
(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
Measured: Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startJul 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973245
- Sponsor's protocol ID
- 11866
- Status last verified
- Dec 2014
- First submitted
- 8 Sep 2009
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00973245
- Acronym / sponsor ID
- 11866
- Conditions
- Atrial Fibrillation
- Keywords
- BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Xarelto (Rivaroxaban, BAY59-7939) |
| Arm 2 | Experimental | Drug: Xarelto (Rivaroxaban, BAY59-7939) |
| Arm 4 | Active comparator | Drug: Warfarin |
| Arm 3 | Experimental | Drug: Xarelto (Rivaroxaban, BAY59-7939) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xarelto (Rivaroxaban, BAY59-7939)10mg od | Drug | Arm 1 |
| Xarelto (Rivaroxaban, BAY59-7939)15mg od | Drug | Arm 2 |
| Xarelto (Rivaroxaban, BAY59-7939)20mg od | Drug | Arm 3 |
| WarfarinDose-adjusted warfarin based on target INR values | Drug | Arm 4 |
Primary outcome
(Safety) Incidence of bleeding
Time frame: Throughout treatment and followup period
(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
Time frame: Day 14 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xarelto (Rivaroxaban, BAY59-7939) and Warfarin in people with Atrial Fibrillation, run by Bayer at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Safety) Incidence of bleeding (time frame: Throughout treatment and followup period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.