A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation (OPAL-2) 


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2009)		Incidence of major and clinically relevant non-major bleeding events [ Time Frame: Double-blind treatment period (variable, up to 16 months) ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00938730 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: July 13, 2009)
  • 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) ] [ Designated as safety issue: No ]
  • Incidence of bleeding events [ Time Frame: Double-blind treatment period (variable, up to 16 months) ] [ Designated as safety issue: Yes ]
  • Assessment of other safety variables [ Time Frame: Double blind treatment period (variable, up to 16 months) ] [ Designated as safety issue: No ]
  • Assessment of PK/PD variables [ Time Frame: Double-blind treatment period (up to week 12) ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes [ Time Frame: Double-blind treatment period (up to week 24) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEAtrial Fibrillation
Intervention  ICMJE
  • Drug: YM150
    oral
  • Drug: Warfarin
    oral
Study Arms / Comparison Groups
  • 1. YM150, Dose W, twice daily: Experimental
    Intervention: Drug: YM150
  • 2. YM150, Dose X, once daily: Experimental
    Intervention: Drug: YM150
  • 3. YM150, Dose X, twice daily: Experimental
    Intervention: Drug: YM150
  • 4. YM150, Dose Y once daily: Experimental
    Intervention: Drug: YM150
  • 5. YM150, Dose Y twice daily: Experimental
    Intervention: Drug: YM150
  • 6. YM150, Dose Z, once daily: Experimental
    Intervention: Drug: YM150
  • 7. Warfarin: Active Comparator
    Intervention: Drug: Warfarin

Recruitment Information

Estimated Enrollment  ICMJE1280
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Astellas Pharma Europe BV Medical Clinical Development Department+ 31 (0)71 54 55878
Location Countries  ICMJEAustralia,   Austria,   Bulgaria,   Czech Republic,   Estonia,   France,   Germany,   Hungary,   India,   Indonesia,   Israel,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Philippines,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Thailand,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00938730
Responsible PartyDisclosure Office Europe, Astellas Pharma Europe BV
Study ID Numbers  ICMJE150-CL-021, EudraCT number: 2007-001150-87
Study Sponsor  ICMJEAstellas Pharma Inc
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Use Central ContactAstellas Pharma Europe BV
Information Provided ByAstellas Pharma Inc