Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Ataxia Clinical Trial

Official title:

Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428531
• Other study ID #: 115489
• Status: Completed
• Phase: N/A
• First received: September 1, 2011
• Last updated: July 13, 2015
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).

("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with acute pulmonary thromboembolism or acute deep venous thrombosis

• Fondaparinux injection must be prescribed for the first time

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ataxia
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Fondaparinux Sodium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse drug reaction		3 months	Yes
Primary	Number of patients with any serious adverse event		3 months	Yes
Primary	Number of patients with any hemorrhagic adverse event		3 months	Yes
Primary	Presence or absence of reoccurrence of VTE		3 months	Yes