DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation

Completed

Phase 2 Results

Trial Description

This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).

Conditions

Interventions

  • DU-176b tablets Drug
    Intervention Desc: DU-176b tablets taken once daily for up to 3 months
    ARM 1: Kind: Experimental
    Label: 1
    Description: DU-176b tablets: low-dose
    ARM 2: Kind: Experimental
    Label: 2
    Description: DU-176b tablets: high-dose
  • Warfarin tablets Drug
    Intervention Desc: Warfarin tablets taken once daily for up to 3 months
    ARM 1: Kind: Experimental
    Label: 3
    Description: Warfarin tablets

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF. 6 months Yes
Secondary Evaluation of incidence of major adverse cardiovascular events: stroke, systemic embolic event, myocardial infarction, cardiovascular death, and hospitalization for any cardiac condition 6 months Yes
Secondary Evaluation of effects on biomarkers of thrombus formation 6 months Yes
Secondary Evaluation of plasma concentration of DU-176 6 months No
Secondary Evaluation of effects on pharmacodynamic biomarkers 6 months No
Secondary Evaluation of all clinical and laboratory safety data. 6 months Yes
Primary Incidence of All Bleeding 6 months Yes

Sponsors