Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||See Detailed Description|
- Relationship between anti IIa (a biomarker)and the dose of SB424323.
- Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.
|Study Start Date:||November 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (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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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|