Conditions: Embolism, Pulmonary
Keywords: Fondaparinux sodium contrast-enhanced MDCT Deep Vein Thrombosis Pulmonary thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Fondaparinux sodium intervention 2: unfractionated heparin (UFH)
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: