Atrial FibrillationPhase 2NCT00448214
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
A Phase 2 study testing YM150 and warfarin in people with Atrial Fibrillation, run by Astellas Pharma Inc at 18 sites in 10 countries.
Trial summary
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- YM150 and warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 18 sitesin 10 countries
- Study dates
- Mar 2007to Oct 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible for the study if all of the following apply:
- Subject has paroxysmal permanent or persistent NVAF
- Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
- Legal minimum age requirement (country-specific).
- Written informed consent has been obtained.
Who cannot join
- History of heart valve disorders
- History of rheumatic fever.
- History of stroke and/or systemic embolism (including TIA).
- History of Acute Coronary Syndrome (ACS).
- Indication for warfarin other than NVAF.
- Known hemorrhagic disorder and/or coagulation disorder.
- Active bleeding or any condition associated with increased risk of bleeding.
Trial locations and contacts
18 sites in 10 countries.
18 sites in 10 countries
Japan6 sites
Study site
Hokkaido
Study site
Kansai
Study site
Kanto
Study site
Kyusyu
Study site
Shikoku
Study site
Tōhoku
Thailand3 sites
Study site
Bangkok
Study site
Chiang Mai
Study site
Nakhon Ratchasima
About this study
Official title: Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
- Conditions
- Atrial Fibrillation
- Being tested
- YM150, warfarin
- Keywords
- Factor Xa inhibitor, Atrial fibrillation, Stroke, Ischemic attack, thromboembolism, Prevention and control
- Medical subject headings
- Atrial Fibrillation, Stroke, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
Oral
warfarinDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low dose Receives: Drug: YM150 |
| 2 | Experimental | Middle dose Receives: Drug: YM150 |
| 3 | Experimental | High dose Receives: Drug: YM150 |
| 4 | Active comparator | Not described Receives: Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
Measured: 16 Weeks
Secondary outcomes (6)
Incidence of symptomatic stroke
Measured: 16 Weeks
Incidence of transient ischemic attack (TIA)
Measured: 16 Weeks
Incidence of systemic thromboembolic event
Measured: 16 Weeks
Incidence of the bleeding rates
Measured: 16 Weeks
Other safety assessments
Measured: 16 Weeks
PK, PD variables
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448214
- Sponsor's protocol ID
- 150-CL-030
- Status last verified
- Dec 2011
- First submitted
- 15 Mar 2007
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin
- ClinicalTrials.gov ID
- NCT00448214
- Acronym / sponsor ID
- 150-CL-030
- Conditions
- Atrial Fibrillation
- Keywords
- Factor Xa inhibitor, Atrial fibrillation, Stroke, Ischemic attack, thromboembolism, Prevention and control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Mar 2007 (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.
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: YM150Low dose |
| 2 | Experimental | Drug: YM150Middle dose |
| 3 | Experimental | Drug: YM150High dose |
| 4 | Active comparator | Drug: warfarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has paroxysmal permanent or persistent NVAF
- Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
- Legal minimum age requirement (country-specific).
- Written informed consent has been obtained.
Key exclusion criteria (7 listed)
- History of heart valve disorders
- History of rheumatic fever.
- History of stroke and/or systemic embolism (including TIA).
- History of Acute Coronary Syndrome (ACS).
- Indication for warfarin other than NVAF.
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 |
|---|---|---|
| YM150Oral | Drug | 1, 2, 3 |
| warfarinOral | Drug | 4 |
Primary outcome
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
Time frame: 16 Weeks
6 secondary outcomes
Incidence of symptomatic stroke
Time frame: 16 Weeks
Incidence of transient ischemic attack (TIA)
Time frame: 16 Weeks
Incidence of systemic thromboembolic event
Time frame: 16 Weeks
Incidence of the bleeding rates
Time frame: 16 Weeks
Other safety assessments
Time frame: 16 Weeks
PK, PD variables
Time frame: 16 Weeks
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 19 Dec 2011.
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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.
Central Contact study chair
Astellas Pharma Inc
18 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM150 and warfarin in people with Atrial Fibrillation, run by Astellas Pharma Inc at 18 sites in 10 countries.
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 5 inclusion and 7 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan, Thailand, Hong Kong, Australia, Malaysia and 5 more countries. 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?
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)" (time frame: 16 Weeks). 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 19 Dec 2011.