A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation
NCT ID: NCT00938730
Last Updated: 2011-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1280 participants
INTERVENTIONAL
2009-06-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1. YM150, Dose W, twice daily
YM150
oral
2. YM150, Dose X, once daily
YM150
oral
3. YM150, Dose X, twice daily
YM150
oral
4. YM150, Dose Y once daily
YM150
oral
5. YM150, Dose Y twice daily
YM150
oral
6. YM150, Dose Z, once daily
YM150
oral
7. Warfarin
Warfarin
oral
Interventions
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YM150
oral
Warfarin
oral
Eligibility Criteria
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Inclusion Criteria
* Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Europe BV
Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Auchenflower, , Australia
Caboolture, , Australia
Kippa-Ring, , Australia
Victoria, , Australia
Vienna, , Austria
Vienna, , Austria
Dimitrovgrad, , Bulgaria
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Besenov, , Czechia
Havirov-mesto, , Czechia
Prague, , Czechia
Tábor, , Czechia
Ústí nad Labem, , Czechia
Narva, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Paris, , France
Bad Nauheim, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Darmstadt, , Germany
Dresden, , Germany
Hagen, , Germany
Kassel, , Germany
Mainz, , Germany
Mannheim, , Germany
Markkleeberg, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Mosonmagyaróvár, , Hungary
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
Ahmedabad, , India
Bangalore, , India
Bangalore, , India
Bangalore, , India
Hyderabaad, , India
Kolkata, , India
Madurai, , India
Nagpur, , India
Nashik, , India
Nellore, , India
Pune, , India
Pune, , India
Nahariya, , Israel
Nazareth, , Israel
Rehovot, , Israel
Asahikawa, , Japan
Atsugi, , Japan
Bunkyō City, , Japan
Daitō, , Japan
Fujisawa, , Japan
Funabashi, , Japan
Hachiōji, , Japan
Higashiibaraki-gun, , Japan
Hiroshima, , Japan
Kanazawa, , Japan
Kasaoka, , Japan
Kishiwada, , Japan
Kitamoto, , Japan
Kiyose, , Japan
Kobe, , Japan
Meguro-ku, , Japan
Morioka, , Japan
Nankoku, , Japan
Sapporo, , Japan
Sapporo, , Japan
Sendai, , Japan
Shimajiri-gun, , Japan
Shinjyuku-ku, , Japan
Shizuoka, , Japan
Toyama, , Japan
Wako, , Japan
Yokohama, , Japan
Kuala Lumpur, , Malaysia
Selangor Darul Ehsan, , Malaysia
AD Delft, , Netherlands
AE Roosendaal, , Netherlands
BC Amsterdam, , Netherlands
Iloilo City, , Philippines
Bytom, , Poland
Gdynia, , Poland
Gdynia, , Poland
Katowice, , Poland
Kielce, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Torun, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Arkhangelsk, , Russia
Chelyabinsk, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Smolensk, , Russia
Tomsk, , Russia
Tula, , Russia
Tyumen, , Russia
Bardejov, , Slovakia
Dolný Kubín, , Slovakia
Komárno, , Slovakia
Košice, , Slovakia
Liptovský Hrádok, , Slovakia
Martin, , Slovakia
Bellville, , South Africa
Benoni, , South Africa
Centurion, , South Africa
Chatsworth, , South Africa
Moreletapark, , South Africa
Somerset West, , South Africa
Tongaat, , South Africa
Umhlanga, , South Africa
Worcester, , South Africa
Busan, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Murcia, , Spain
Seville, , Spain
Viladecans, , Spain
Bangkok, , Thailand
Chiang Mai, , Thailand
Cherkassy, , Ukraine
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Ternopil, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Addlestone, , United Kingdom
Bath, , United Kingdom
Birmingham, , United Kingdom
Dundee, , United Kingdom
East Horsley, , United Kingdom
London, , United Kingdom
Soham, , United Kingdom
Southampton, , United Kingdom
Countries
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Other Identifiers
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2007-001150-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
150-CL-021
Identifier Type: -
Identifier Source: org_study_id
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