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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01390883

First received: July 7, 2011

Last updated: March 26, 2015

Last verified: March 2015

History of Changes

Purpose

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.

Condition	Intervention
Cardiovascular Disease	Drug: Fondaparinux Sodium


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

Resource links provided by NLM:

Drug Information available for: Fondaparinux Fondaparinux sodium

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The number of adverse events in Japanese patients treated with fondaparinux [ Time Frame: 4 months at maximum ] [ Designated as safety issue: Yes ]
Presence or absence of venous thromboembolism after treatment of fondaparinux [ Time Frame: 4 months at maximum ] [ Designated as safety issue: Yes ]


Enrollment:	475
Study Start Date:	December 2008
Study Completion Date:	October 2013
Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients prescribed fondaparinux Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period	Drug: Fondaparinux Sodium

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Japanese patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390883

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01390883 History of Changes
Other Study ID Numbers:	112721
Study First Received:	July 7, 2011
Last Updated:	March 26, 2015
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:


Cardiovascular Diseases Fondaparinux PENTA Anticoagulants	Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016

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