A Phase 2 interventional study of YM150 and Warfarin in Atrial Fibrillation, sponsored by Astellas Pharma Inc. Completed at 170 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-20.
Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Prevention
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 1,280 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: YM150
Drug: YM150
Drug: YM150
Drug: YM150
Drug: YM150
Drug: YM150
Drug: Warfarin
oral
oral
Incidence of major and clinically relevant non-major bleeding events
Time frame: Double-blind treatment period (variable, up to 16 months)
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)
Showing the first 100 of 170 sites across 23 countries.
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc