Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00320424

First received: May 1, 2006

Last updated: October 1, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 1, 2006

Last Updated Date

October 1, 2010

Start Date ^ICMJE

February 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rate of adjudicated VTE (venous thromboembolism) [DVT (deep vein thrombosis) or PE] based on the assessment of venograms.

Original Primary Outcome Measures ^ICMJE

Rate of adjudicated VTE (DVT or PE) based on the assessment of venograms.

Change History

Complete list of historical versions of study NCT00320424 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of PE, DVT, proximal DVT, distal only DVT

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

Official Title ^ICMJE

Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery

Brief Summary

This study is requested by PMDA to confirm the efficacy and the safety for HFS.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hip Fracture
Surgery

Intervention ^ICMJE

Drug: Fondaparinux

Other Name: Fondaparinux

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).

Exclusion Criteria:

Active, clinically significant bleeding (excluding drainage).

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00320424

Other Study ID Numbers ^ICMJE

AR3106335

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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