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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00938730




Registration number
NCT00938730
Ethics application status
Date submitted
1/07/2009
Date registered
14/07/2009
Date last updated
20/01/2011

Titles & IDs
Public title
A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation
Scientific 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
Secondary ID [1] 0 0
2007-001150-87
Secondary ID [2] 0 0
150-CL-021
Universal Trial Number (UTN)
Trial acronym
OPAL-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YM150
Treatment: Drugs - Warfarin

Experimental: 1. YM150, Dose W, twice daily -

Experimental: 2. YM150, Dose X, once daily -

Experimental: 3. YM150, Dose X, twice daily -

Experimental: 4. YM150, Dose Y once daily -

Experimental: 5. YM150, Dose Y twice daily -

Experimental: 6. YM150, Dose Z, once daily -

Active comparator: 7. Warfarin -


Treatment: Drugs: YM150
oral

Treatment: Drugs: Warfarin
oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of major and clinically relevant non-major bleeding events
Timepoint [1] 0 0
Double-blind treatment period (variable, up to 16 months)
Secondary outcome [1] 0 0
Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths
Timepoint [1] 0 0
Double-blind treatment period (variable, up to 16 months)
Secondary outcome [2] 0 0
Incidence of bleeding events
Timepoint [2] 0 0
Double-blind treatment period (variable, up to 16 months)
Secondary outcome [3] 0 0
Assessment of other safety variables
Timepoint [3] 0 0
Double blind treatment period (variable, up to 16 months)
Secondary outcome [4] 0 0
Assessment of PK/PD variables
Timepoint [4] 0 0
Double-blind treatment period (up to week 12)
Secondary outcome [5] 0 0
Patient Reported Outcomes
Timepoint [5] 0 0
Double-blind treatment period (up to week 24)

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
1280
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Auchenflower
Recruitment hospital [2] 0 0
- Caboolture
Recruitment hospital [3] 0 0
- Kippa Ring
Recruitment hospital [4] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4510 - Caboolture
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
3181 - Victoria
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Dimitrovgrad
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Pleven
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Bulgaria
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Sofia
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Czech Republic
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Besenov
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Czech Republic
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Havirov-mesto
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Czech Republic
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Prague
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Czech Republic
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Tabor
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Czech Republic
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Usti Nad Labem
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Estonia
State/province [10] 0 0
Narva
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Paris
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Germany
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Bad Nauheim
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Germany
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Berlin
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Germany
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Darmstadt
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Germany
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Dresden
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Germany
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Hagen
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Germany
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Kassel
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Markkleeberg
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Hungary
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Balatonfured
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Mosonmagyarovar
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Hungary
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Nyiregyhaza
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Hungary
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Szekesfehervar
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India
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Ahmedabad
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India
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Bangalore
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India
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Hyderabaad
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India
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Kolkatta
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India
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Madurai
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India
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Nagpur
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India
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Nashik
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India
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Nellore
Country [37] 0 0
India
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Pune
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Israel
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Nahariya
Country [39] 0 0
Israel
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Nazareth
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Israel
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Rehovot
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Japan
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Asahikawa
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Japan
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Atsugi
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Japan
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Bunkyo-ku
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Japan
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Daito
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Japan
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Fujisawa
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Japan
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Funabashi
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Japan
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Hachioji
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Higashiibaraki-gun
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Japan
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Hiroshima
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Kanazawa
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Japan
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Kasaoka
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Kishiwada
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Kitamoto
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Kiyose
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Japan
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Kobe
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Japan
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Meguro-ku
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Japan
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Morioka
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Japan
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Nankoku
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Sapporo
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Sendai
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Shimajiri-gun
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Shinjyuku-ku
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Shizuoka
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Toyama
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Wako
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Yokohama
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Korea, Republic of
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Busan
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Gwangju
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In Cheon
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Seoul
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Kuala Lumpur
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Selangor Darul Ehsan
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Netherlands
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AD Delft
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AE Roosendaal
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BC Amsterdam
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Iloilo
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Bytom
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Torun
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Warsaw
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Wroclaw
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Chelyabinsk
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Omsk
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Saratov
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Smolensk
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tula
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Russian Federation
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Tyumen
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Slovakia
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Bardejov
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Dolny Kubin
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Komarno
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Kosice
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Slovakia
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Liptovsky Hradok
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Slovakia
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Martin
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South Africa
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Bellville
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Benoni
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Centurion
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Chatsworth
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Umhlanga
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Worcester
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Viladecans
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Ukraine
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Cherkassy
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Ukraine
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Donetsk
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Ukraine
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Ivano Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odessa
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Ukraine
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Ternopil
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhya
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Addlestone
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Bath
Country [132] 0 0
United Kingdom
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Birmingham
Country [133] 0 0
United Kingdom
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Dundee
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United Kingdom
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East Horsley
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United Kingdom
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London
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United Kingdom
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Soham
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United Kingdom
State/province [137] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00938730
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Use Central Contact
Address 0 0
Astellas Pharma Europe B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00938730