Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
CALISTO: Arixtra in superficial thrombophlebitis
NCT00443053Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Jul 2009
- Countries
- 17
- Sponsor
- GSK
- Modality
- Allosteric Modulators
- Drugs
- fondaparinux
- Conditions
- superficial thrombophlebitis (SVT)
01
Overview
Phase 3, randomised, double-blind trial in superficial thrombophlebitis (SVT) comparing Fondaparinux 2.5mg with Placebo (2 arms). Primary endpoint: Composite of Venous Thromboembolism (VTE) and/or Death From Any Cause at Day 47. Started Mar 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Fondaparinux 2.5mg
Fondaparinux 2.5mg SC once daily
Placebo
Matching placebo SC once daily
03
Who it enrols
Adult patients with acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long. Excludes patients with DVT/PE, recent cancer treatment, recent major surgery, or severe renal impairment.
04
Endpoints
Primary
Composite of Venous Thromboembolism (VTE) and/or Death From Any Cause
Secondary
Composite of Venous Thromboembolism (VTE) and/or Death From Any Cause
Surgery to Treat Superficial Vein Thrombosis Recurrence
Major Bleeding Events
Non-Major Bleeding Events
05
Results
Primary endpoints met
Beyond the preview
Go deeper on NCT00443053.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00443053.