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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
  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
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

Resource links provided by NLM:


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) ]

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) ]
  • Incidence of bleeding events [ Time Frame: Double-blind treatment period (variable, up to 16 months) ]
  • Assessment of other safety variables [ Time Frame: Double blind treatment period (variable, up to 16 months) ]
  • Assessment of PK/PD variables [ Time Frame: Double-blind treatment period (up to week 12) ]
  • Patient Reported Outcomes [ Time Frame: Double-blind treatment period (up to week 24) ]

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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 )
Study First Received: July 1, 2009
Last Updated: January 18, 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

ClinicalTrials.gov processed this record on August 17, 2017