Completed
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
What is being tested
Data Collection
Who is being recruted
Arrhythmias, Cardiac+9
+ Atrial Fibrillation
+ Brain Diseases
From 18 to 75 Years
+10 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 2
Interventional
Study Start: November 2005
Summary
Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2005
Actual date on which the first participant was enrolled.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
Official TitleA 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
Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
640 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Arrhythmias, CardiacAtrial FibrillationBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersHeart DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesStroke
Criteria
5 inclusion criteria required to participate
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.
Show More Criteria
5 exclusion criteria prevent from participating
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.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 116 locations
Suspended
Suspended
GSK Investigational Site
Troy, United StatesSuspended
GSK Investigational Site
Akron, United StatesSuspended
GSK Investigational Site
Cincinnati, United StatesCompleted116 Study Centers