Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Thromboembolism Clinical Trial

Official title:

Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420809
• Other study ID #: 112285
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: May 15, 2017
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.

(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

Exclusion Criteria:

Related Conditions & MeSH terms

• Thromboembolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb		3 months
Primary	Occurrence of adverse events of bleeding		3 months
Primary	Presence or absence of venous thromboembolism after treatment of fondaparinux		3 months