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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00938730
First received: July 1, 2009
Last updated: January 18, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Drug: YM150
Drug: Warfarin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1280
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. YM150, Dose W, twice daily Drug: YM150
oral
Experimental: 2. YM150, Dose X, once daily Drug: YM150
oral
Experimental: 3. YM150, Dose X, twice daily Drug: YM150
oral
Experimental: 4. YM150, Dose Y once daily Drug: YM150
oral
Experimental: 5. YM150, Dose Y twice daily Drug: YM150
oral
Experimental: 6. YM150, Dose Z, once daily Drug: YM150
oral
Active Comparator: 7. Warfarin Drug: Warfarin
oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938730

  Show 170 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe BV
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00938730     History of Changes
Other Study ID Numbers: 150-CL-021, 2007-001150-87
Study First Received: July 1, 2009
Last Updated: January 18, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Indonesia: National Agency of Drug and Food Control
Israel: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: Ministry of Health

Keywords provided by Astellas Pharma Inc:
Nonvalvular Atrial Fibrillation (NVAF)
Factor Xa Inhibitor
Stroke
Thromboembolism
Transient Ischemic attack
 Anticoagulants
Prevention
YM150
Warfarin

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013