Last updated: 11/04/2018 04:42:19

Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

GSK study ID
AR3106335
See study documents
Clinicaltrials.gov ID
NCT00320424
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism after Hip Fracture Surgery
Trial description: This study is requested by PMDA to confirm the efficacy and the safety for HFS.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Rate of major bleeding during treatment period

Timeframe: From the first study drug injection up to Day 17

Secondary outcomes:

Rate of PE during treatment period

Timeframe: Up to Day 17

Rate of DVT during treatment period

Timeframe: Up to Day 17

Rate of proximal DVT during treatment period

Timeframe: Up to Day 17

Rate of distal only DVT during treatment period

Timeframe: Up to Day 17

Number of participants with major bleeding during treatment period

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Number of participants with minor bleeding and any bleeding (major and/or minor bleeding)

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Number of participants with adverse events (AE), serious adverse events (SAE) and death

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Number of transfused participants

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Summary of units transfused

Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Rate of symptomatic DVT

Timeframe: Up to Day 17

Interventions:
Drug: Fondaparinux
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
2006-26-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Thromboembolism
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
February 2006 to October 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
  • 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).
  • Active, clinically significant bleeding (excluding drainage).
Inclusion and exclusion criteria
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).

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Unknown, Japan
Status
Study Complete
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2006-26-10
Actual study completion date
2006-26-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website