Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
Phase 2
Completed
- Conditions
- Fibrillation, AtrialAtrial Fibrillation
- Registration Number
- NCT00240643
- Lead Sponsor
- GlaxoSmithKline
- 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 640
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Relationship between anti IIa (a biomarker)and the dose of SB424323.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧York, United Kingdom