Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
This study is requested by PMDA to confirm the efficacy and the safety for HFS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2006
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2006
CompletedFirst Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2006
CompletedResults Posted
Study results publicly available
October 11, 2017
CompletedSeptember 4, 2018
August 1, 2018
8 months
May 1, 2006
May 12, 2017
August 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Major Bleeding During Treatment Period
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
From the first study drug injection up to Day 17
Secondary Outcomes (10)
Rate of PE During Treatment Period
Up to Day 17
Rate of DVT During Treatment Period
Up to Day 17
Rate of Proximal DVT During Treatment Period
Up to Day 17
Rate of Distal Only DVT During Treatment Period
Up to Day 17
Number of Participants With Major Bleeding During Treatment Period
From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Active, clinically significant bleeding (excluding drainage).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
February 16, 2006
Primary Completion
October 26, 2006
Study Completion
October 26, 2006
Last Updated
September 4, 2018
Results First Posted
October 11, 2017
Record last verified: 2018-08