NCT00981409

The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.

Conditions

• Embolism, Pulmonary

Interventions

Type	Name	Description
DRUG	Fondaparinux sodium	The dose of Fondaparinux will be determined based on a subject's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection.
DRUG	unfractionated heparin (UFH)	UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT) to maintain aPTT 1.5 to 2.5 times control.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2009-09-22
• Last updated: 2016-12-16
• Results posted: 2009-12-10

Locations

27 sites across 1 country: Japan