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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240643
First received: October 14, 2005
Last updated: February 11, 2013
Last verified: February 2013
History of Changes

October 14, 2005
February 11, 2013
November 2005
December 2006   (final data collection date for primary outcome measure)
Relationship between anti IIa (a biomarker)and the dose of SB424323.
- relationship between anti IIa (a biomarker)and the dose of SB424323
Complete list of historical versions of study NCT00240643 on ClinicalTrials.gov Archive Site
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.
  • -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
Not Provided
Not Provided
 
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
See Detailed Description

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Fibrillation, Atrial
  • Atrial Fibrillation
Drug: SB424323
Other Name: SB424323
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
640
December 2006
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   Denmark,   Estonia,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Korea, Republic of,   Latvia,   Mexico,   Netherlands,   New Zealand,   Norway,   Romania,   Spain,   Sweden,   Taiwan,   Thailand,   United Kingdom
 
NCT00240643
101724
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP