Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/14/2017 |
| Start Date: | November 2005 |
| End Date: | December 2006 |
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
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.
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
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
Inclusion Criteria:
- Patients with non valvular atrial fibrillation and any of the following:
-
- 60 years old with heart disease but no risk factors.
- >/=60 years old and
- 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.
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