Phase 3 N=48 Prevention

Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

Thromboembolism

Bottom Line

View on ClinicalTrials.gov: NCT00320424 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Oct 2017

Primary outcome: Primary: Rate of Major Bleeding During Treatment Period — 21.6 % of normalized events per participant

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fondaparinux (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Oct 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Major Bleeding During Treatment Period	21.6	—
SECONDARY Rate of PE During Treatment Period	—	—
SECONDARY Rate of DVT During Treatment Period	21.6	—
SECONDARY Rate of Proximal DVT During Treatment Period	2.6	—
SECONDARY Rate of Distal Only DVT During Treatment Period	21.6	—
SECONDARY Number of Participants With Major Bleeding During Treatment Period	—	—
SECONDARY Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)	0; 0	—
SECONDARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death	37; 2; 0	—
SECONDARY Number of Transfused Participants	1	—
SECONDARY Summary of Units Transfused	280	—
SECONDARY Rate of Symptomatic DVT	—	—

Summary

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

Eligibility 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00320424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.