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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00938730
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : January 20, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: YM150 Drug: Warfarin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2009
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of major and clinically relevant non-major bleeding events [ Time Frame: Double-blind treatment period (variable, up to 16 months) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Incidence of bleeding events [ Time Frame: Double-blind treatment period (variable, up to 16 months) ]
  3. Assessment of other safety variables [ Time Frame: Double blind treatment period (variable, up to 16 months) ]
  4. Assessment of PK/PD variables [ Time Frame: Double-blind treatment period (up to week 12) ]
  5. Patient Reported Outcomes [ Time Frame: Double-blind treatment period (up to week 24) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938730


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

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 ( EudraCT Number )
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: January 2011

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
Darexaban
Warfarin
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action