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

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ClinicalTrials.gov Identifier: NCT00333021
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Fondaparinux sodium Drug: GSK576428 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery
Study Start Date : May 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Fondaparinux sodium Drug: GSK576428
    Other Name: Fondaparinux sodium


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

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


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00333021


Locations
Japan
GSK Investigational Site
Hiroshima, Japan, 737-0811
GSK Investigational Site
Hokkaido, Japan, 060-0061
GSK Investigational Site
Hokkaido, Japan, 060-8543
GSK Investigational Site
Hokkaido, Japan, 073-0164
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, 890-0061
GSK Investigational Site
Kagoshima, Japan, 892-8580
GSK Investigational Site
Nara, Japan, 630-0227
GSK Investigational Site
Osaka, Japan, 540-0006
GSK Investigational Site
Osaka, Japan, 560-0055
GSK Investigational Site
Osaka, Japan, 565-0871
GSK Investigational Site
Osaka, Japan, 589-8511
GSK Investigational Site
Osaka, Japan, 590-0132
GSK Investigational Site
Osaka, Japan, 598-0048
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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00333021     History of Changes
Other Study ID Numbers: AR3106116
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009

Keywords provided by GlaxoSmithKline:
Fondaparinux Abdominal surgery Japanese VTE

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
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