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SB424323

Phase 2

Fibrillation, Atrial | Small molecule | Cardiovascular |GSK plc|Last Updated: Jan 16, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment640

FDA Designations

No designations recorded

Clinical trial landscape

SB424323 · 1 trial · 2 indications

Phase 2 1
NCT00240643Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For StrokeFibrillation, Atrial
COMPLETED640 Analytics
PHASE2COMPLETED
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
Fibrillation, AtrialUnlock trial analytics

Study Endpoints

Primary Endpoints

Relationship between anti IIa (a biomarker)and the dose of SB424323.

Secondary Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
SB424323DRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites116

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 ...

Countries:United StatesArgentinaBelgiumBrazilCanadaDenmarkEstoniaFranceGermanyGreeceHungaryIndiaItalyLatviaMexicoNetherlandsNew ZealandNorwayRomaniaSouth KoreaSpainSwedenTaiwanThailandUnited Kingdom
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Frequently asked questions about SB424323

What is SB-424323 used for?

SB-424323 is an investigational small molecule being studied for use in arthroplasty and in non-valvular atrial fibrillation in patients at low or intermediate risk for stroke. It is being developed by GSK plc and is currently in Phase 2 clinical development.

What does SB-424323 target?

SB-424323 is a small molecule being studied for its potential to prevent thromboembolism. It is being evaluated in patients undergoing arthroplasty and in patients with non-valvular atrial fibrillation, where it is being tested in combination with aspirin.

Who makes SB-424323?

SB-424323 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical development.

What phase is SB-424323 in?

SB-424323 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one in arthroplasty and one in atrial fibrillation.

What clinical trials is SB-424323 in?

SB-424323 has been studied in two completed Phase 2 trials. The ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST, NCT00041509) enrolled 343 patients undergoing arthroplasty. A second trial (NCT00240643) enrolled 640 patients with non-valvular atrial fibrillation and evaluated SB-424323 in combination with aspirin.

Is SB-424323 the same as TEMPEST?

No, SB-424323 is the drug being studied, while TEMPEST is the name of one of its clinical trials. The ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST, NCT00041509) is a Phase 2 study of SB-424323 in patients undergoing arthroplasty.