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.
Phase of Trial: Phase II
Latest Information Update: 19 Jan 2017
At a glance
- Drugs Odiparcil (Primary)
- Indications Stroke; Thromboembolism; Transient ischaemic attacks
- Focus Biomarker; Pharmacodynamics
- Sponsors GlaxoSmithKline
- 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.
- 20 May 2009 Additional locations (USA, Canada) identified as reported by ClinicalTrials.gov.