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CompletedNCT01428544

Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

Status
Completed
Phase
Study type
Observational
Enrollment
5 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day. ("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)

Conditions

Interventions

TypeNameDescription
DRUGFondaparinux sodiumFor patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.

Timeline

Start date
2012-03-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2011-09-05
Last updated
2015-07-15

Source: ClinicalTrials.gov record NCT01428544. Inclusion in this directory is not an endorsement.

Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg) (NCT01428544) · Clinical Trials Directory