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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00240643

Enrollment

640

Registered

2005-10-18

Start date

2005-11-30

Completion date

2006-12-31

Last updated

2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Fibrillation, Atrial

Keywords

non valvular atrial fibrillation, stroke, aspirin

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

Interventions

DRUGSB424323

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Relationship between anti IIa (a biomarker)and the dose of SB424323.	—

Secondary

Measure	Time frame
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.	—

Countries

Argentina, Belgium, Brazil, Canada, Denmark, Estonia, France, Germany, Greece, Hungary, India, Italy, Latvia, Mexico, Netherlands, New Zealand, Norway, Romania, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026