NCT00443053

Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,002 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Detailed description

Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

Conditions

• Thrombosis, Venous

Interventions

Type	Name	Description
DRUG	Fondaparinux 2.5mg or placebo	Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-03-05
• Last updated: 2017-03-06
• Results posted: 2010-08-02

Locations

227 sites across 17 countries: Bulgaria, Czechia, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Netherlands, Poland, Russia, Slovakia, Spain, Switzerland, Ukraine