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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
640
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.
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GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Troy, Michigan, United States
GSK Investigational Site
Akron, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Camp Hill, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Walla Walla, Washington, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina
...and 106 more locations