drugset / Trial / NCT00981409

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

NCT00981409

Phase 3 Completed 41 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-07
Primary completion
2008-12
Completion
2008-12

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

Indications