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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01390883
First received: July 7, 2011
Last updated: July 14, 2011
Last verified: July 2011
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:

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
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (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

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

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01390883     History of Changes
Other Study ID Numbers: 112721
Study First Received: July 7, 2011
Last Updated: July 14, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Cardiovascular Diseases
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013