A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation (OPAL-2)
Tracking InformationStart Date ICMJE | June 2009 |
---|
Estimated Primary Completion Date | August 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 ICMJE | Same as current |
---|
Change History | Complete 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 ICMJE | Same as current |
---|
Descriptive InformationBrief Title ICMJE | A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation |
---|
Official Title ICMJE | 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 |
---|
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 Phase | Phase II |
---|
Study Type ICMJE | Interventional |
---|
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
---|
Condition ICMJE | Atrial 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 InformationEstimated Enrollment ICMJE | 1280 |
---|
Estimated Completion Date | August 2010 |
---|
Estimated Primary Completion Date | August 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
|
---|
Gender | Both |
---|
Ages | 18 Years and older |
---|
Accepts Healthy Volunteers | No |
---|
Contacts ICMJE | Contact: Astellas Pharma Europe BV Medical Clinical Development Department | + 31 (0)71 54 55878 | | |
|
---|
Location Countries ICMJE | Australia, 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 InformationNCT ID ICMJE | NCT00938730 |
---|
Responsible Party | Disclosure Office Europe, Astellas Pharma Europe BV |
---|
Study ID Numbers ICMJE | 150-CL-021, EudraCT number: 2007-001150-87 |
---|
Study Sponsor ICMJE | Astellas Pharma Inc |
---|
Collaborators ICMJE | |
---|
Investigators ICMJE | Study Chair: | Use Central Contact | Astellas Pharma Europe BV | |
|
---|
Information Provided By | Astellas Pharma Inc |
---|
|