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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240643
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : January 16, 2017
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Fibrillation, Atrial Atrial Fibrillation Drug: SB424323 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Relationship between anti IIa (a biomarker)and the dose of SB424323.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240643

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Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00240643    
Other Study ID Numbers: 101724
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Keywords provided by GlaxoSmithKline:
non valvular atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes