Status:
COMPLETED
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
Lead Sponsor:
GlaxoSmithKline
Conditions:
Fibrillation, Atrial
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- Patients with non valvular atrial fibrillation and any of the following:
- \</= 60 years old with no heart disease.
- 60 years old with heart disease but no risk factors.
- \>/=60 years old and \</=75 years old with no risk factors and no heart disease.
- Must be able to take aspirin.
Exclusion
- Previous heart attack or stroke.
- History of high blood pressure, diabetes or a prior blood clot.
- Liver or kidney disease.
- Need for anti-thrombotic or anti-platelet drugs.
- Need for cardiovascular medicines.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT00240643
Start Date
November 1 2005
End Date
December 1 2006
Last Update
January 16 2017
Active Locations (116)
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1
GSK Investigational Site
Mobile, Alabama, United States, 36608
2
GSK Investigational Site
Troy, Michigan, United States, 48098
3
GSK Investigational Site
Akron, Ohio, United States, 44313
4
GSK Investigational Site
Cincinnati, Ohio, United States, 45224