Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

Cardiovascular Disease Clinical Trial

Official title:

Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390883
• Other study ID #: 112721
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: March 26, 2015
• Start date: December 2008
• Est. completion date: October 2013

Study information

• Verified date: March 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 study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments

Exclusion Criteria:

• Patients with a history of hypersensitivity to the ingredients of fondaparinux

• Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)

• Patients with acute bacterial endocarditis

• Patients with severe renal impairment

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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	The number of adverse events in Japanese patients treated with fondaparinux		4 months at maximum	Yes
Primary	Presence or absence of venous thromboembolism after treatment of fondaparinux		4 months at maximum	Yes