Atrial FibrillationPhase 2NCT00779064
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
A Phase 2 study testing Rivaroxaban (BAY59-7939) in people with Atrial Fibrillation, run by Bayer at 12 sites in Japan.
Trial summary
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with 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?
- Rivaroxaban (BAY59-7939)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 12 sitesJapan
- Study dates
- Jul 2004to Jun 2005
- 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
- 20 years or older
- Japanese male or female
- Non- valvular atrial fibrillation documented by ECG
- Patients aged 60 years and older or with a risk of stroke
Who cannot join
- Prior stroke and TIA
- Patients in whom anticoagulants are contraindicated
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Study site
Amagasaki, Hyōgo, 660-8511
Study site
Fukuoka, Fukuoka, 811-0213
Study site
Fukuoka, Fukuoka, 814-0180
Study site
Kawachi-Nagano, Osaka, 586-8521
Study site
Kitahiroshima, Hokkaido, 061-1134
Study site
Kitakyushu, Fukuoka, 800-0057
Study site
Koga, Fukuoka, 807-0051
Study site
Kurume, Fukuoka, 830-8577
Study site
Osaka, Osaka, 540-0006
Study site
Osaka, Osaka, 553-0003
Study site
Osaka, Osaka, 558-8558
Study site
Suita, Osaka, 565-0871
About this study
This is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (BAY59-7939)
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (BAY59-7939)Drug
10mg BID, Semi-sequential, dose escalation.
Rivaroxaban (BAY59-7939)Drug
20mg BID, Semi-sequential, dose escalation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Rivaroxaban (BAY59-7939) |
| Arm 2 | Experimental | Not described Receives: Drug: Rivaroxaban (BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)
Measured: Day 14 and 28
Secondary outcomes (1)
Each category of bleeding events and adverse event
Measured: Throughout treatment and followup period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJul 2004
- Primary completionJun 2005
- Study completionJun 2005
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00779064
- Sponsor's protocol ID
- 11390
- Status last verified
- Dec 2014
- First submitted
- 17 Oct 2008
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status
- ClinicalTrials.gov ID
- NCT00779064
- Acronym / sponsor ID
- 11390
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 24 Oct 2008 (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 a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of BAY 59-7939 in patients with atrial fibrillation (originally described in Japanese).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rivaroxaban (BAY59-7939) |
| Arm 2 | Experimental | Drug: 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 (4 listed)
- 20 years or older
- Japanese male or female
- Non- valvular atrial fibrillation documented by ECG
- Patients aged 60 years and older or with a risk of stroke
Key exclusion criteria (2 listed)
- Prior stroke and TIA
- Patients in whom anticoagulants are contraindicated
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 |
|---|---|---|
| Rivaroxaban (BAY59-7939)10mg BID, Semi-sequential, dose escalation. | Drug | Arm 1 |
| Rivaroxaban (BAY59-7939)20mg BID, Semi-sequential, dose escalation. | Drug | Arm 2 |
Primary outcome
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R)
Time frame: Day 14 and 28
1 secondary outcome
Each category of bleeding events and adverse event
Time frame: Throughout treatment and followup period
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 25 Dec 2014.
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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
12 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 Rivaroxaban (BAY59-7939) in people with Atrial Fibrillation, run by Bayer at 12 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 4 inclusion and 2 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 25 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 12 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?
Pharmacokinetics (PK) CL/f, AUC, Cmax, Pharmacodynamics (PD), Factor Xa activity, PT, PT-INR, aPTT and HEPTEST(R) (time frame: Day 14 and 28). 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 25 Dec 2014.