Last updated: 11/04/2018 04:42:03
Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese patients
Clinicaltrials.gov ID
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 (VTE) after Abdominal Surgery
Trial description: This study is phase 3 study for prevention of VTE in patients with abdominal surgery.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Incidence of Venous thromboembolism and Major bleeding
Timeframe: Throughout entire study
Secondary outcomes:
Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism
Timeframe: Throughout entire study
Interventions:
Drug: Fondaparinux sodium
Drug: GSK576428
Enrollment:
127
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Venous thromboembolism
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
May 2006 to February 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
- General or urologic surgery
- Active, clinically significant bleeding
- Thrombocytopenia
Inclusion and exclusion criteria
Inclusion criteria:
- Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
- General or urologic surgery
- Cancer surgery
- Gynecologic surgery
- Radical surgery for pelvic malignancy
Exclusion criteria:
- Active, clinically significant bleeding Thrombocytopenia Body weight <40kg
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-16-02
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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Access to clinical trial data by researchers
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