Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Wednesday 29th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00938730
Ethics application status
Date submitted
1/07/2009
Date registered
13/07/2009
Date last updated
18/01/2011

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
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
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 -

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

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)
Primary outcome [2] 0 0
Incidence of major and clinically relevant non-major bleeding events
Timepoint [2] 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)
Secondary outcome [6] 0 0
Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths
Timepoint [6] 0 0
Double-blind treatment period (variable, up to 16 months)
Secondary outcome [7] 0 0
Incidence of bleeding events
Timepoint [7] 0 0
Double-blind treatment period (variable, up to 16 months)
Secondary outcome [8] 0 0
Assessment of other safety variables
Timepoint [8] 0 0
Double blind treatment period (variable, up to 16 months)
Secondary outcome [9] 0 0
Assessment of PK/PD variables
Timepoint [9] 0 0
Double-blind treatment period (up to week 12)
Secondary outcome [10] 0 0
Patient Reported Outcomes
Timepoint [10] 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sofia
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Besenov
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Havirov-mesto
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Prague
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Tabor
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Usti Nad Labem
Country [10] 0 0
Estonia
State/province [10] 0 0
Narva
Country [11] 0 0
Estonia
State/province [11] 0 0
Tallinn
Country [12] 0 0
Estonia
State/province [12] 0 0
Tartu
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
Germany
State/province [14] 0 0
Bad Nauheim
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Darmstadt
Country [17] 0 0
Germany
State/province [17] 0 0
Dresden
Country [18] 0 0
Germany
State/province [18] 0 0
Hagen
Country [19] 0 0
Germany
State/province [19] 0 0
Kassel
Country [20] 0 0
Germany
State/province [20] 0 0
Mainz
Country [21] 0 0
Germany
State/province [21] 0 0
Mannheim
Country [22] 0 0
Germany
State/province [22] 0 0
Markkleeberg
Country [23] 0 0
Hungary
State/province [23] 0 0
Balatonfured
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Debrecen
Country [26] 0 0
Hungary
State/province [26] 0 0
Mosonmagyarovar
Country [27] 0 0
Hungary
State/province [27] 0 0
Nyiregyhaza
Country [28] 0 0
Hungary
State/province [28] 0 0
Szekesfehervar
Country [29] 0 0
India
State/province [29] 0 0
Ahmedabad
Country [30] 0 0
India
State/province [30] 0 0
Bangalore
Country [31] 0 0
India
State/province [31] 0 0
Hyderabaad
Country [32] 0 0
India
State/province [32] 0 0
Kolkatta
Country [33] 0 0
India
State/province [33] 0 0
Madurai
Country [34] 0 0
India
State/province [34] 0 0
Nagpur
Country [35] 0 0
India
State/province [35] 0 0
Nashik
Country [36] 0 0
India
State/province [36] 0 0
Nellore
Country [37] 0 0
India
State/province [37] 0 0
Pune
Country [38] 0 0
Israel
State/province [38] 0 0
Nahariya
Country [39] 0 0
Israel
State/province [39] 0 0
Nazareth
Country [40] 0 0
Israel
State/province [40] 0 0
Rehovot
Country [41] 0 0
Japan
State/province [41] 0 0
Asahikawa
Country [42] 0 0
Japan
State/province [42] 0 0
Atsugi
Country [43] 0 0
Japan
State/province [43] 0 0
Bunkyo-ku
Country [44] 0 0
Japan
State/province [44] 0 0
Daito
Country [45] 0 0
Japan
State/province [45] 0 0
Fujisawa
Country [46] 0 0
Japan
State/province [46] 0 0
Funabashi
Country [47] 0 0
Japan
State/province [47] 0 0
Hachioji
Country [48] 0 0
Japan
State/province [48] 0 0
Higashiibaraki-gun
Country [49] 0 0
Japan
State/province [49] 0 0
Hiroshima
Country [50] 0 0
Japan
State/province [50] 0 0
Kanazawa
Country [51] 0 0
Japan
State/province [51] 0 0
Kasaoka
Country [52] 0 0
Japan
State/province [52] 0 0
Kishiwada
Country [53] 0 0
Japan
State/province [53] 0 0
Kitamoto
Country [54] 0 0
Japan
State/province [54] 0 0
Kiyose
Country [55] 0 0
Japan
State/province [55] 0 0
Kobe
Country [56] 0 0
Japan
State/province [56] 0 0
Meguro-ku
Country [57] 0 0
Japan
State/province [57] 0 0
Morioka
Country [58] 0 0
Japan
State/province [58] 0 0
Nankoku
Country [59] 0 0
Japan
State/province [59] 0 0
Sapporo
Country [60] 0 0
Japan
State/province [60] 0 0
Sendai
Country [61] 0 0
Japan
State/province [61] 0 0
Shimajiri-gun
Country [62] 0 0
Japan
State/province [62] 0 0
Shinjyuku-ku
Country [63] 0 0
Japan
State/province [63] 0 0
Shizuoka
Country [64] 0 0
Japan
State/province [64] 0 0
Toyama
Country [65] 0 0
Japan
State/province [65] 0 0
Wako
Country [66] 0 0
Japan
State/province [66] 0 0
Yokohama
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Busan
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Gwangju
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
In Cheon
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Seoul
Country [71] 0 0
Malaysia
State/province [71] 0 0
Kuala Lumpur
Country [72] 0 0
Malaysia
State/province [72] 0 0
Selangor Darul Ehsan
Country [73] 0 0
Netherlands
State/province [73] 0 0
AD Delft
Country [74] 0 0
Netherlands
State/province [74] 0 0
AE Roosendaal
Country [75] 0 0
Netherlands
State/province [75] 0 0
BC Amsterdam
Country [76] 0 0
Philippines
State/province [76] 0 0
Iloilo
Country [77] 0 0
Poland
State/province [77] 0 0
Bytom
Country [78] 0 0
Poland
State/province [78] 0 0
Gdynia
Country [79] 0 0
Poland
State/province [79] 0 0
Katowice
Country [80] 0 0
Poland
State/province [80] 0 0
Kielce
Country [81] 0 0
Poland
State/province [81] 0 0
Krakow
Country [82] 0 0
Poland
State/province [82] 0 0
Lodz
Country [83] 0 0
Poland
State/province [83] 0 0
Lublin
Country [84] 0 0
Poland
State/province [84] 0 0
Torun
Country [85] 0 0
Poland
State/province [85] 0 0
Warsaw
Country [86] 0 0
Poland
State/province [86] 0 0
Wroclaw
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Arkhangelsk
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Chelyabinsk
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Moscow
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Novosibirsk
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Omsk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Saratov
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Smolensk
Country [94] 0 0
Russian Federation
State/province [94] 0 0
St Petersburg
Country [95] 0 0
Russian Federation
State/province [95] 0 0
St. Petersburg
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Tomsk
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Tula
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Tyumen
Country [99] 0 0
Slovakia
State/province [99] 0 0
Bardejov
Country [100] 0 0
Slovakia
State/province [100] 0 0
Dolny Kubin
Country [101] 0 0
Slovakia
State/province [101] 0 0
Komarno
Country [102] 0 0
Slovakia
State/province [102] 0 0
Kosice
Country [103] 0 0
Slovakia
State/province [103] 0 0
Liptovsky Hradok
Country [104] 0 0
Slovakia
State/province [104] 0 0
Martin
Country [105] 0 0
South Africa
State/province [105] 0 0
Bellville
Country [106] 0 0
South Africa
State/province [106] 0 0
Benoni
Country [107] 0 0
South Africa
State/province [107] 0 0
Centurion
Country [108] 0 0
South Africa
State/province [108] 0 0
Chatsworth
Country [109] 0 0
South Africa
State/province [109] 0 0
Moreletta Park
Country [110] 0 0
South Africa
State/province [110] 0 0
Somerset West
Country [111] 0 0
South Africa
State/province [111] 0 0
Tongaat
Country [112] 0 0
South Africa
State/province [112] 0 0
Umhlanga
Country [113] 0 0
South Africa
State/province [113] 0 0
Worcester
Country [114] 0 0
Spain
State/province [114] 0 0
Murcia
Country [115] 0 0
Spain
State/province [115] 0 0
Sevilla
Country [116] 0 0
Spain
State/province [116] 0 0
Viladecans
Country [117] 0 0
Thailand
State/province [117] 0 0
Bangkok
Country [118] 0 0
Thailand
State/province [118] 0 0
Chiang Mai
Country [119] 0 0
Ukraine
State/province [119] 0 0
Cherkassy
Country [120] 0 0
Ukraine
State/province [120] 0 0
Donetsk
Country [121] 0 0
Ukraine
State/province [121] 0 0
Ivano Frankivsk
Country [122] 0 0
Ukraine
State/province [122] 0 0
Kharkiv
Country [123] 0 0
Ukraine
State/province [123] 0 0
Kyiv
Country [124] 0 0
Ukraine
State/province [124] 0 0
Lutsk
Country [125] 0 0
Ukraine
State/province [125] 0 0
Lviv
Country [126] 0 0
Ukraine
State/province [126] 0 0
Odessa
Country [127] 0 0
Ukraine
State/province [127] 0 0
Ternopil
Country [128] 0 0
Ukraine
State/province [128] 0 0
Vinnytsya
Country [129] 0 0
Ukraine
State/province [129] 0 0
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
State/province [132] 0 0
Birmingham
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Dundee
Country [134] 0 0
United Kingdom
State/province [134] 0 0
East Horsley
Country [135] 0 0
United Kingdom
State/province [135] 0 0
London
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Soham
Country [137] 0 0
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/show/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
Other publications