drugset / Trial / NCT00911157

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

NCT00911157

Phase 3 Completed 39 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-06
Primary completion
2009-11
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fondaparinux Other / unclassified 5 mg Subcutaneous
Subject Fondaparinux Other / unclassified 7.5 mg Subcutaneous
Subject Fondaparinux Other / unclassified 10 mg Subcutaneous
Subject Heparin Other / unclassified