Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
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ClinicalTrials.gov Identifier: NCT01390883 |
Recruitment Status
:
Completed
First Posted
: July 11, 2011
Last Update Posted
: March 27, 2015
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Condition or disease | Intervention/treatment |
---|---|
Cardiovascular Disease | Drug: Fondaparinux Sodium |
Study Type : | Observational |
Actual Enrollment : | 475 participants |
Time Perspective: | Prospective |
Official Title: | Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology) |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2013 |
Group/Cohort | Intervention/treatment |
---|---|
Patients prescribed fondaparinux
Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period
|
Drug: Fondaparinux Sodium |
- The number of adverse events in Japanese patients treated with fondaparinux [ Time Frame: 4 months at maximum ]
- Presence or absence of venous thromboembolism after treatment of fondaparinux [ Time Frame: 4 months at maximum ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390883
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01390883 History of Changes |
Other Study ID Numbers: |
112721 |
First Posted: | July 11, 2011 Key Record Dates |
Last Update Posted: | March 27, 2015 |
Last Verified: | March 2015 |
Additional relevant MeSH terms:
Cardiovascular Diseases Fondaparinux PENTA Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |