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GSK576428

Phase 3

Venous Thromboembolism | Small molecule | Cardiovascular |GSK plc|Last Updated: Jul 10, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment127

FDA Designations

No designations recorded

Clinical trial landscape

GSK576428 · 1 trial · 1 indication

Phase 3 1
NCT00333021Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese PatientsVenous Thromboembolism
COMPLETED127 Analytics
PHASE3COMPLETED
Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients
Venous Thromboembolism
NCT00333021127
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Study Endpoints

Primary Endpoints

Incidence of Venous thromboembolism and Major bleeding
Throughout entire study

Secondary Endpoints

Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism
Throughout entire study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Fondaparinux sodiumDRUG -
GSK576428DRUG -
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion criteria: * Patients aged \>=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes. * General or urologic surgery * Cancer surgery * Gynecologic surgery * Radical surgery for pelvic malignancy Exclusion crite...

Countries:Japan
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