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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation; Fibrillation, Atrial

Treatments: Drug: SB424323

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240643

101724

Details and patient eligibility

About

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.

Full 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

Enrollment: 640 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind