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A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 [odiparcil] (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke.

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Trial Profile

A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 [odiparcil] (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Sep 2023

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At a glance

  • Drugs Odiparcil (Primary) ; Aspirin
  • Indications Stroke
  • Focus Biomarker; Pharmacodynamics
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 12 May 2019 This trial has been completed in Denmark as per European Clinical Trials Database record.
    • 13 Oct 2012 New source identified and integrated (European Clinical Trials Database record: EudraCT2005-001256-20).
    • 24 Jan 2011 Additional trial location (Australia) identified as reported by ClinicalTrials.gov.

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