Last updated: 11/04/2018 04:42:11
Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism after Elective Total Hip Replacement Surgery
Trial description: This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Percentage of participants with venous thromboembolism (VTE) during efficacy period
Timeframe: Up to Day 17
Percentage of participants with Major bleeding
Timeframe: Up to Day 17
Secondary outcomes:
Percentage of participants with minor bleeding
Timeframe: Up to Day 17
Percentage of participants with all deep vein thrombosis (DVT)
Timeframe: Up to Day 17
Percentage of participants with proximal DVT
Timeframe: Up to Day 17
Percentage of participants with distal only DVT
Timeframe: Up to Day 17
Percentage of participants with symptomatic DVT during main efficacy period
Timeframe: Up to Day 17
Percentage of participants with pulmonary embolism during efficacy period
Timeframe: Up to Day 17
Number of participants with adverse events (AEs), serious adverse events (SAEs) and deaths
Timeframe: From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.
Number of transfused participants
Timeframe: Up to Day 17.
Volume of transfusion
Timeframe: Up to Day 17
Interventions:
Drug: Fondaparinux
Enrollment:
114
Observational study model:
Not applicable
Primary completion date:
2006-18-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Thrombosis, Venous
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
January 2006 to July 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
- Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.
- Active, clinically significant bleeding (excluding drainage).
Inclusion and exclusion 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).
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
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
2006-18-07
Actual study completion date
2006-18-07
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
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