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Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00333021
First received: June 1, 2006
Last updated: July 9, 2009
Last verified: July 2009
  Purpose

This study is phase 3 study for prevention of VTE in patients with abdominal surgery.


Condition Intervention Phase
Venous Thromboembolism
Drug: Fondaparinux sodium
Drug: GSK576428
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of Venous thromboembolism and Major bleeding [ Time Frame: Throughout entire study ]

Secondary Outcome Measures:
  • Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism [ Time Frame: Throughout entire study ]

Enrollment: 127
Study Start Date: May 2006
Study Completion Date: February 2007
Intervention Details:
    Drug: Fondaparinux sodium Drug: GSK576428
    Other Names:
    • Fondaparinux sodium
    • GSK576428
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
  • General or urologic surgery
  • Cancer surgery
  • Gynecologic surgery
  • Radical surgery for pelvic malignancy

Exclusion criteria:

  • Active, clinically significant bleeding Thrombocytopenia Body weight <40kg
  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: NCT00333021

Locations
Japan
GSK Investigational Site
Hiroshima, Japan, 737-0811
GSK Investigational Site
Hokkaido, Japan, 060-0061
GSK Investigational Site
Hokkaido, Japan, 073-0164
GSK Investigational Site
Hokkaido, Japan, 060-8543
GSK Investigational Site
Hyogo, Japan, 655-0004
GSK Investigational Site
Ibaraki, Japan, 300-0053
GSK Investigational Site
Kagawa, Japan, 760-0017
GSK Investigational Site
Kagoshima, Japan, 892-8580
GSK Investigational Site
Kagoshima, Japan, 890-0061
GSK Investigational Site
Nara, Japan, 630-0227
GSK Investigational Site
Osaka, Japan, 560-0055
GSK Investigational Site
Osaka, Japan, 589-8511
GSK Investigational Site
Osaka, Japan, 565-0871
GSK Investigational Site
Osaka, Japan, 590-0132
GSK Investigational Site
Osaka, Japan, 598-0048
GSK Investigational Site
Osaka, Japan, 540-0006
GSK Investigational Site
Saitama, Japan, 351-0102
GSK Investigational Site
Tokyo, Japan, 152-0021
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00333021     History of Changes
Other Study ID Numbers: AR3106116
Study First Received: June 1, 2006
Last Updated: July 9, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Fondaparinux Abdominal surgery Japanese VTE

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

ClinicalTrials.gov processed this record on November 24, 2014