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

Completed · Phase 2

Conditions studied: Fibrillation, Atrial, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00240643

Run by

GlaxoSmithKline

People needed

640

Starts

2005-11-01

Expected to finish

2006-12-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• GSK Investigational Site — Capital Federal, Buenos Aires, Argentina
• GSK Investigational Site — Capital Fefderal, Buenos Aires, Argentina
• GSK Investigational Site — Córdoba, Córdoba Province, Argentina
• GSK Investigational Site — Córdoba, Córdoba Province, Argentina
• GSK Investigational Site — Rosario, Santa Fe Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Moron-Provincia de Buenos Aires, Argentina
• GSK Investigational Site — Antwerp, Belgium
• GSK Investigational Site — Linkebeek, Belgium
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• GSK Investigational Site — São Paulo, São Paulo, Brazil
• GSK Investigational Site — Halifax, Nova Scotia, Canada
• GSK Investigational Site — Truro, Nova Scotia, Canada
• GSK Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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