Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
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|ClinicalTrials.gov Identifier: NCT00240643|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : January 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibrillation, Atrial Atrial Fibrillation||Drug: SB424323||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|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|
- Relationship between anti IIa (a biomarker)and the dose of SB424323.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00240643
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|