NCT00240643

Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke

A Randomized, Double Blind, Double Dummy, Parallel Group, Placebo Controlled Study to Evaluate the Pharmacodynamic and Pharmacokinetic Response and Safety and Tolerability of SB424323 (250mg, 375mg and 500 mg) Administered Twice Daily for 16 Weeks, on Top of Asprin (325mg, qd) in Men and Women With Non Valvular Atrial Fibrillation at a Low or Intermediate Risk for Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 640 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Fibrillation, Atrial
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	SB424323

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-10-18
• Last updated: 2017-01-16

Locations

116 sites across 25 countries: United States, Argentina, Belgium, Brazil, Canada, Denmark, Estonia, France, Germany, Greece, Hungary, India, Italy, Latvia, Mexico, Netherlands, New Zealand, Norway, Romania, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom