At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,002 enrolled
Drug / intervention
Fondaparinux 2.5mg or placebodrug
Likely dose
Fondaparinux 2.5mg or placebofrom 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.
An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications
In Brief
A Phase 3 clinical trial evaluating Fondaparinux 2.5mg or placebo for Thrombosis, Venous. Completed, enrolled 3,002 participants across 227 sites in 17 countries.
Detailed Summary
To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombosis, Venous
CountriesBulgaria, Czechia, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Netherlands, Poland, Russia, Slovakia, Spain, Switzerland, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMar 2007
Primary CompletionJul 2009
TodayJul 2026
First PostedMar 5, 2007
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.3 years ago
Interventions
Fondaparinux 2.5mg or placebodrug
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day