Recent Updates
Recently added Catalysts

GSK576428

Phase 4

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

GSK576428 development status

Highest phase Phase 4 run by National Medical Research Center for Therapy and Preventive Medicine (NCT05001776)
Phase scored for GSKPhase 3
Registered trials 11 across 2 sponsors since Jun 2002

GSK576428 target and mechanism

ModalitySmall molecule

Also known as Fondaparinux sodium

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment127

FDA Designations

No designations recorded

GSK576428 clinical trials

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 ThromboembolismUnlock trial analytics

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Fondaparinux sodiumDRUG -
GSK576428DRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about GSK576428

What is GSK576428?

GSK576428 is an investigational small molecule developed by GSK plc for the prevention of venous thromboembolism. It has been studied in a Phase 3 trial in Japanese patients undergoing abdominal surgery. GSK576428 is also known as fondaparinux sodium.

What is GSK576428 used for?

GSK576428 is being developed for venous thromboembolism, a condition involving blood clots in the veins. Its Phase 3 study evaluated the drug in Japanese patients undergoing abdominal surgery, a setting where clot prevention is a clinical concern.

Who makes GSK576428?

GSK576428 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 3 abdominal surgery study of the drug in Japanese patients.

What phase is GSK576428 in?

GSK576428 has completed a Phase 3 clinical trial. It is an investigational agent and is not described as approved by the FDA. The completed Phase 3 study enrolled 127 patients in Japan.

What clinical trials is GSK576428 in?

GSK576428 has been studied in one Phase 3 trial, NCT00333021, titled Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium) In Japanese Patients. The trial enrolled 127 patients with venous thromboembolism in Japan and is completed.

Is GSK576428 the same as fondaparinux sodium?

Yes, GSK576428 is also known as fondaparinux sodium. The Phase 3 trial NCT00333021 lists the drug under both names in its title, studying it in Japanese patients undergoing abdominal surgery for venous thromboembolism.