NCT01499953

Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: GWT-TUD GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).

Detailed description

Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment

Conditions

• Superficial Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
DRUG	Fondaparinux	Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2011-12-26
• Last updated: 2023-05-15
• Results posted: 2023-05-15

Locations

23 sites across 1 country: Germany