CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 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/NCT00911157
NCT00911157Phase 3Completed
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Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT)

GlaxoSmithKline·interventional·Posted Jun 1, 2009·Updated Nov 23, 2016

In Brief

A Phase 3 clinical trial evaluating Fondaparinux sodium and unfractionated heparin (UFH) for Thrombosis, Venous. Completed, enrolled 39 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombosis, Venous
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 1, 2009
Enrollment StartJun 1, 2008
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.1 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.