Atrial FibrillationPhase 2OPAL-2NCT00938730
A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation
A Phase 2 study testing YM150 and Warfarin in people with Atrial Fibrillation, run by Astellas Pharma Inc at 170 sites in 23 countries.
Trial summary
The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data. 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
- 1,280 participants
- Where
- 170 sitesin 23 countries
- Study dates
- Jun 2009to Sep 2010
- 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
- Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
- Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit
Who cannot join
- Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
- Subject has active bleeding or any condition associated with increased risk of bleeding
- Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
- Subject has an indication for warfarin other than AF (including planned cardioversion)
- Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
- Subject has a diagnosis of left ventricular aneurysm or atrial myxoma
Show all 11Show fewer
- Subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics [such as tissue Plasminogen Activator (tPA), streptokinase], antiplatelet agents [such as cilostazol, clopidogrel, ticlopidine, dipyridamole], anticoagulants [such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors] and chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs] or acetylsalicylic acid use of >100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
- Subject has active infective endocarditis
- Subject is planned for invasive procedures with potential for bleeding
- Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
- Subject has participated in any YM150 clinical trials
Trial locations and contacts
170 sites in 23 countries.
170 sites in 23 countries
Japan27 sites
Study site
Asahikawa, 078-8214
Study site
Atsugi, 243-8550
Study site
Bunkyō City, 113-8603
Study site
Daitō, 574-0074
Study site
Fujisawa, 251-8550
Study site
Funabashi, 274-8503
Study site
Hachiōji, 193-0098
Study site
Higashiibaraki-gun, 311 3193
Study site
Hiroshima
Study site
Kanazawa, 920 8650
Study site
Kasaoka, 714-0043
Study site
Kishiwada, 596-8522
Study site
Kitamoto, 364-8501
Study site
Kiyose, 204 8585
Study site
Kobe, 651-1145
Study site
Meguro-ku, 153-8515
Study site
Morioka, 020-8505
Study site
Nankoku, 783-8509
Study site
Sapporo, 060-0011
Study site
Sapporo, 063 0005
Study site
Sendai, 983 8520
Study site
Shimajiri-gun, 901-0496
Study site
Shinjyuku-ku, 162-8543
Study site
Shizuoka, 421-0117
Study site
Toyama, 939-8511
Study site
Wako, 351 0102
Study site
Yokohama, 227-0046
Ukraine19 sites
Study site
Cherkassy, 18009
Study site
Donetsk, 83114
Study site
Ivano-Frankivsk, 76075
Study site
Kharkiv, 61002
Study site
Kharkiv, 61018
Study site
Kharkiv, 61037
Study site
Kharkiv, 61039
Study site
Kharkiv, 61178
Study site
Kyiv, 02038
Study site
Kyiv, 02660
Study site
Kyiv, 03680
Study site
Kyiv, 3680
Study site
Kyiv, 4050
Study site
Lutsk, 43024
Study site
Lviv, 79013
Study site
Odesa, 65059
Study site
Ternopil, 46002
Study site
Vinnytsia, 21005
Study site
Zaporizhzhya, 69118
Russia15 sites
Study site
Arkhangelsk, 163045
Study site
Chelyabinsk, 454021
Study site
Moscow, 101990
Study site
Moscow, 117485
Study site
Novosibirsk, 630008
Study site
Novosibirsk, 630012
Study site
Novosibirsk, 630117
Study site
Omsk, 644046
Study site
Saint Petersburg, 194156
Study site
Saint Petersburg, 199106
Study site
Saratov, 410028
Study site
Smolensk, 214018
Study site
Tomsk, 643063
Study site
Tula, 300035
Study site
Tyumen, 625026
Poland13 sites
Study site
Bytom, 41-902
Study site
Gdynia, 81-423
Study site
Gdynia, 81-472
Study site
Katowice, 40-635
Study site
Kielce, 25-735
Study site
Krakow, 30-082
Study site
Lodz, 91-425
Study site
Lublin, 20-954
Study site
Torun, 87-100
Study site
Warsaw, 00-909
Study site
Warsaw, 02-057
Study site
Warsaw, 02-097
Study site
Wroclaw, 50-981
India12 sites
Study site
Ahmedabad, 380054
Study site
Bangalore, 560034
Study site
Bangalore, 560052
Study site
Bangalore, 560053
Study site
Hyderabaad, 500036
Study site
Kolkata, 700054
Study site
Madurai, 625107
Study site
Nagpur, 440012
Study site
Nashik, 42202
Study site
Nellore, 524003
Study site
Pune, 411001
Study site
Pune, 411004
Germany11 sites
Study site
Bad Nauheim, 61231
Study site
Berlin, 10115
Study site
Berlin, 10117
Study site
Berlin, 10367
Study site
Darmstadt, 64283
Study site
Dresden, 1307
Study site
Hagen, 58099
Study site
Kassel, 34121
Study site
Mainz, 55116
Study site
Mannheim, 68169
Study site
Markkleeberg, 04416
South Africa9 sites
Study site
Bellville, 7530
Study site
Benoni, 1500
Study site
Centurion, 0157
Study site
Chatsworth, 4092
Study site
Moreletapark, 0044
Study site
Somerset West, 7130
Study site
Tongaat, 4400
Study site
Umhlanga, 4320
Study site
Worcester, 6850
United Kingdom8 sites
Study site
Addlestone, KT 15 2BH
Study site
Bath, BA2 3HT
Study site
Birmingham, B18 7QH
Study site
Dundee, DD1 9SY
Study site
East Horsley, KT24 6QT
Study site
London, SE5 8AF
Study site
Soham, CB7 5JD
Study site
Southampton, SO16 6YD
Bulgaria7 sites
Study site
Dimitrovgrad, 6400
Study site
Pleven, 5800
Study site
Sofia, 1202
Study site
Sofia, 1309
Study site
Sofia, 1407
Study site
Sofia, 1505
Study site
Sofia, 1606
South Korea7 sites
Study site
Busan, 603-175
Study site
Gwangju, 501-757
Study site
Incheon, 405-760
Study site
Seoul, 120-752
Study site
Seoul, 137-701
Study site
Seoul, 138-736
Study site
Seoul, 158-710
Hungary6 sites
Study site
Balatonfüred, H-8230
Study site
Budapest, H-1134
Study site
Debrecen, H-4030
Study site
Mosonmagyaróvár, H-9200
Study site
Nyíregyháza, H-4400
Study site
Székesfehérvár, H-8000
Slovakia6 sites
Study site
Bardejov, 08501
Study site
Dolný Kubín, 02601
Study site
Komárno, 94501
Study site
Košice, 04022
Study site
Liptovský Hrádok, 03301
Study site
Martin, 03601
Czechia5 sites
Study site
Besenov, 25630
Study site
Havirov-mesto, 73601
Study site
Prague, 13
Study site
Tábor, 2000
Study site
Ústí nad Labem, 40113
Australia4 sites
Study site
Auchenflower, 4066
Study site
Caboolture, 4510
Study site
Kippa-Ring, 4021
Study site
Victoria, 3181
Estonia4 sites
Study site
Narva, 20307
Study site
Tallinn, 10138
Study site
Tallinn, 10617
Study site
Tartu, 51014
Israel3 sites
Study site
Nahariya, 22100
Study site
Nazareth, 16100
Study site
Rehovot, 76100
Netherlands3 sites
Study site
AD Delft, 2625
Study site
AE Roosendaal, 4708
Study site
BC Amsterdam, 1091
Spain3 sites
Study site
Murcia, 30008
Study site
Seville, 41009
Study site
Viladecans, 08840
Malaysia2 sites
Study site
Kuala Lumpur, 50586
Study site
Selangor Darul Ehsan, 47500
About this study
Official title: A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With Warfarin
The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.
- Conditions
- Atrial Fibrillation
- Being tested
- YM150, Warfarin
- Keywords
- Nonvalvular Atrial Fibrillation (NVAF), Factor Xa Inhibitor, Stroke, Thromboembolism, Transient Ischemic attack, Anticoagulants, Prevention, YM150, Warfarin
- Medical subject headings
- Atrial Fibrillation, Stroke, Thromboembolism, Ischemic Attack, Transient
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. YM150, Dose W, twice daily | Experimental | Not described Receives: Drug: YM150 |
| 2. YM150, Dose X, once daily | Experimental | Not described Receives: Drug: YM150 |
| 3. YM150, Dose X, twice daily | Experimental | Not described Receives: Drug: YM150 |
| 4. YM150, Dose Y once daily | Experimental | Not described Receives: Drug: YM150 |
| 5. YM150, Dose Y twice daily | Experimental | Not described Receives: Drug: YM150 |
| 6. YM150, Dose Z, once daily | Experimental | Not described Receives: Drug: YM150 |
| 7. Warfarin | Active comparator | Not described Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major and clinically relevant non-major bleeding events
Measured: Double-blind treatment period (variable, up to 16 months)
Secondary outcomes (5)
Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths
Measured: Double-blind treatment period (variable, up to 16 months)
Incidence of bleeding events
Measured: Double-blind treatment period (variable, up to 16 months)
Assessment of other safety variables
Measured: Double blind treatment period (variable, up to 16 months)
Assessment of PK/PD variables
Measured: Double-blind treatment period (up to week 12)
Patient Reported Outcomes
Measured: Double-blind treatment period (up to week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
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
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938730
- Sponsor's protocol ID
- 150-CL-021
- Other IDs
- 2007-001150-87
- Acronym
- OPAL-2
- Status last verified
- Jan 2011
- First submitted
- 1 Jul 2009
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With Warfarin
- ClinicalTrials.gov ID
- NCT00938730
- Acronym / sponsor ID
- OPAL-2 / 150-CL-021
- Conditions
- Atrial Fibrillation
- Keywords
- Nonvalvular Atrial Fibrillation (NVAF), Factor Xa Inhibitor, Stroke, Thromboembolism, Transient Ischemic attack, Anticoagulants, Prevention, YM150
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1. YM150, Dose W, twice daily | Experimental | Drug: YM150 |
| 2. YM150, Dose X, once daily | Experimental | Drug: YM150 |
| 3. YM150, Dose X, twice daily | Experimental | Drug: YM150 |
| 4. YM150, Dose Y once daily | Experimental | Drug: YM150 |
| 5. YM150, Dose Y twice daily | Experimental | Drug: YM150 |
| 6. YM150, Dose Z, once daily | Experimental | Drug: YM150 |
| 7. Warfarin | 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 (2 listed)
- Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
- Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit
Key exclusion criteria (11 listed)
- Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
- Subject has active bleeding or any condition associated with increased risk of bleeding
- Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
- Subject has an indication for warfarin other than AF (including planned cardioversion)
- Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
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. YM150, Dose W, twice daily, 2. YM150, Dose X, once daily, 3. YM150, Dose X, twice daily, 4. YM150, Dose Y once daily, 5. YM150, Dose Y twice daily, 6. YM150, Dose Z, once daily |
| Warfarinoral | Drug | 7. Warfarin |
Primary outcome
Incidence of major and clinically relevant non-major bleeding events
Time frame: Double-blind treatment period (variable, up to 16 months)
5 secondary outcomes
Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths
Time frame: Double-blind treatment period (variable, up to 16 months)
Incidence of bleeding events
Time frame: Double-blind treatment period (variable, up to 16 months)
Assessment of other safety variables
Time frame: Double blind treatment period (variable, up to 16 months)
Assessment of PK/PD variables
Time frame: Double-blind treatment period (up to week 12)
Patient Reported Outcomes
Time frame: Double-blind treatment period (up to week 24)
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 20 Jan 2011.
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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.
Use Central Contact study chair
Astellas Pharma Europe B.V.
170 sites in 23 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 170 sites in 23 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 2 inclusion and 11 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 20 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 170 sites in Japan, Ukraine, Russia, Poland, India and 18 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?
Incidence of major and clinically relevant non-major bleeding events (time frame: Double-blind treatment period (variable, up to 16 months)). 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 20 Jan 2011.