Clinical trial NCT00938730: A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: Nonvalvular Atrial Fibrillation (NVAF)
Factor Xa Inhibitor
Stroke
Thromboembolism
Transient Ischemic attack
Anticoagulants
Prevention
YM150
Warfarin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Incidence of major and clinically relevant non-major bleeding events
timeFrame: Double-blind treatment period (variable, up to 16 months)
Secondary outcomes:
measure: Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths
timeFrame: Double-blind treatment period (variable, up to 16 months)
measure: Incidence of bleeding events
timeFrame: Double-blind treatment period (variable, up to 16 months)
measure: Assessment of other safety variables
timeFrame: Double blind treatment period (variable, up to 16 months)
measure: Assessment of PK/PD variables
timeFrame: Double-blind treatment period (up to week 12)
measure: Patient Reported Outcomes
timeFrame: Double-blind treatment period (up to week 24)
Other outcomes:
Locations:
city: Auchenflower
country: Australia
city: Caboolture
country: Australia
city: Kippa Ring
country: Australia
city: Victoria
country: Australia
city: Wien
country: Austria
city: Wien
country: Austria
city: Dimitrovgrad
country: Bulgaria
city: Pleven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Besenov
country: Czech Republic
city: Havirov-mesto
country: Czech Republic
city: Prague
country: Czech Republic
city: Tabor
country: Czech Republic
city: Usti Nad Labem
country: Czech Republic
city: Narva
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Paris
country: France
city: Bad Nauheim
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Darmstadt
country: Germany
city: Dresden
country: Germany
city: Hagen
country: Germany
city: Kassel
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Markkleeberg
country: Germany
city: Balatonfured
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Mosonmagyarovar
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szekesfehervar
country: Hungary
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Bangalore
country: India
city: Bangalore
country: India
city: Hyderabaad
country: India
city: Kolkatta
country: India
city: Madurai
country: India
city: Nagpur
country: India
city: Nashik
country: India
city: Nellore
country: India
city: Pune
country: India
city: Pune
country: India
city: Nahariya
country: Israel
city: Nazareth
country: Israel
city: Rehovot
country: Israel
city: Asahikawa
country: Japan
city: Atsugi
country: Japan
city: Bunkyo-ku
country: Japan
city: Daito
country: Japan
city: Fujisawa
country: Japan
city: Funabashi
country: Japan
city: Hachioji
country: Japan
city: Higashiibaraki-gun
country: Japan
city: Hiroshima
country: Japan
city: Kanazawa
country: Japan
city: Kasaoka
country: Japan
city: Kishiwada
country: Japan
city: Kitamoto
country: Japan
city: Kiyose
country: Japan
city: Kobe
country: Japan
city: Meguro-ku
country: Japan
city: Morioka
country: Japan
city: Nankoku
country: Japan
city: Sapporo
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Shimajiri-gun
country: Japan
city: Shinjyuku-ku
country: Japan
city: Shizuoka
country: Japan
city: Toyama
country: Japan
city: Wako
country: Japan
city: Yokohama
country: Japan
city: Busan
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: In Cheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur
country: Malaysia
city: Selangor Darul Ehsan
country: Malaysia
city: AD Delft
country: Netherlands
city: AE Roosendaal
country: Netherlands
city: BC Amsterdam
country: Netherlands
city: Iloilo
country: Philippines
city: Bytom
country: Poland
city: Gdynia
country: Poland
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Torun
country: Poland
city: Warsaw
country: Poland
city: Warsaw
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Arkhangelsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Saratov
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tula
country: Russian Federation
city: Tyumen
country: Russian Federation
city: Bardejov
country: Slovakia
city: Dolny Kubin
country: Slovakia
city: Komarno
country: Slovakia
city: Kosice
country: Slovakia
city: Liptovsky Hradok
country: Slovakia
city: Martin
country: Slovakia
city: Bellville
country: South Africa
city: Benoni
country: South Africa
city: Centurion
country: South Africa
city: Chatsworth
country: South Africa
city: Moreletta Park
country: South Africa
city: Somerset West
country: South Africa
city: Tongaat
country: South Africa
city: Umhlanga
country: South Africa
city: Worcester
country: South Africa
city: Murcia
country: Spain
city: Sevilla
country: Spain
city: Viladecans
country: Spain
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Cherkassy
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Addlestone
country: United Kingdom
city: Bath
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Dundee
country: United Kingdom
city: East Horsley
country: United Kingdom
city: London
country: United Kingdom
city: Soham
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_CHAIR
References: