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

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: oral
    ARM 1: Kind: Experimental
    Label: 7. Warfarin
  • YM150 Drug
    Intervention Desc: oral
    ARM 1: Kind: Experimental
    Label: 1. YM150, Dose W, twice daily
    ARM 2: Kind: Experimental
    Label: 2. YM150, Dose X, once daily
    ARM 3: Kind: Experimental
    Label: 3. YM150, Dose X, twice daily
    ARM 4: Kind: Experimental
    Label: 4. YM150, Dose Y once daily
    ARM 5: Kind: Experimental
    Label: 5. YM150, Dose Y twice daily
    ARM 6: Kind: Experimental
    Label: 6. YM150, Dose Z, once daily

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of major and clinically relevant non-major bleeding events Double-blind treatment period (variable, up to 16 months) Yes
Secondary Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths Double-blind treatment period (variable, up to 16 months) No
Secondary Incidence of bleeding events Double-blind treatment period (variable, up to 16 months) Yes
Secondary Assessment of other safety variables Double blind treatment period (variable, up to 16 months) No
Secondary Assessment of PK/PD variables Double-blind treatment period (up to week 12) No
Secondary Patient Reported Outcomes Double-blind treatment period (up to week 24) No

Sponsors