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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
  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:


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 ]
  • Presence or absence of venous thromboembolism after treatment of fondaparinux [ Time Frame: 4 months at maximum ]

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
Sexes Eligible for Study:   All
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

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 June 23, 2017