NCT00911157

The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study 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 symptomatic DVT in an open-label design.

Conditions

• Thrombosis, Venous

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: 2008-06-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-06-01
• Last updated: 2016-11-23
• Results posted: 2010-06-10

Locations

24 sites across 1 country: Japan