Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

Completed

Phase 2 Results N/A

Trial Description

To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Oral
    ARM 1: Kind: Experimental
    Label: 4
  • YM150 Drug
    Intervention Desc: Oral
    ARM 1: Kind: Experimental
    Label: 1
    Description: Low dose
    ARM 2: Kind: Experimental
    Label: 2
    Description: Middle dose
    ARM 3: Kind: Experimental
    Label: 3
    Description: High dose

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 All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)" 16 Weeks Yes
Secondary Incidence of symptomatic stroke 16 Weeks Yes
Secondary Incidence of transient ischemic attack (TIA) 16 Weeks Yes
Secondary Incidence of systemic thromboembolic event 16 Weeks Yes
Secondary Incidence of the bleeding rates 16 Weeks Yes
Secondary Other safety assessments 16 Weeks No
Secondary PK, PD variables 16 Weeks No

Sponsors