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

NCT ID: NCT00333021

Last Updated: 2009-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-02-28

Brief Summary

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

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Fondaparinux sodium

Intervention Type DRUG

GSK576428

Intervention Type DRUG

Other Intervention Names

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Fondaparinux sodium

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hiroshima, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hyōgo, , Japan

Site Status

GSK Investigational Site

Ibaraki, , Japan

Site Status

GSK Investigational Site

Kagawa, , Japan

Site Status

GSK Investigational Site

Kagoshima, , Japan

Site Status

GSK Investigational Site

Kagoshima, , Japan

Site Status

GSK Investigational Site

Nara, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Saitama, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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AR3106116

Identifier Type: -

Identifier Source: org_study_id

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