CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Fondaparinux sodium +1 moredrug
Likely dose
Fondaparinux sodium 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00981409
NCT00981409Phase 3Completed
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Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE)

GlaxoSmithKline·interventional·Posted Sep 22, 2009·Updated Dec 16, 2016

In Brief

A Phase 3 clinical trial evaluating Fondaparinux sodium and unfractionated heparin (UFH) for Embolism, Pulmonary. Completed, enrolled 41 participants across 27 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEmbolism, Pulmonary
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2009
Enrollment StartJul 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.8 years ago

Interventions

Fondaparinux sodiumdrug

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.

unfractionated heparin (UFH)drug

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.