Phase 3
N=114
Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)
Thrombosis, Venous
Bottom Line
View on ClinicalTrials.gov: NCT00320398 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period — 8.3; 2.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fondaparinux (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period |
8.3; 2.2 | — |
| PRIMARY Percentage of Participants With Major Bleeding |
0; 0 | — |
| SECONDARY Percentage of Participants With Minor Bleeding |
1.7; 3.6 | — |
| SECONDARY Percentage of Participants With All Deep Vein Thrombosis (DVT) |
8.3; 2.2 | — |
| SECONDARY Percentage of Participants With Proximal DVT |
0; 0 | — |
| SECONDARY Percentage of Participants With Distal Only DVT |
4; 1 | — |
| SECONDARY Percentage of Participants With Symptomatic DVT During Main Efficacy Period |
0; 0 | — |
| SECONDARY Percentage of Participants With Pulmonary Embolism During Efficacy Period |
0; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths |
0; 0; 0; 0; 49; 45 | — |
| SECONDARY Number of Transfused Participants |
5; 2 | — |
| SECONDARY Volume of Transfusion |
400.0; 600.0 | — |
Summary
This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
Eligibility Criteria
Inclusion Criteria
- Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.
Exclusion Criteria
- Active, clinically significant bleeding (excluding drainage).
Data sourced from ClinicalTrials.gov (NCT00320398). 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.