Last updated: 11/04/2018 02:40:57
ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)TEMPEST
GSK study ID
424323/025
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty
Trial description: The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
VTE
Timeframe: 28 day treatment period
Secondary outcomes:
types of VTE
Timeframe: 28 day treatment period
Interventions:
Drug: SB-424323
Drug: Placebo
Enrollment:
343
Observational study model:
Not applicable
Primary completion date:
2003-31-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Arthroplasty
Product
odiparcil
Collaborators
Not applicable
Study date(s)
January 2002 to May 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
- Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
- Patients who have given written informed consent to participate in this study.
- Patients with a contraindication to contrast venography
- Patients with an increased risk of bleeding.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
- Patients who have given written informed consent to participate in this study.
Exclusion criteria:
- Patients with a contraindication to contrast venography
- Patients with an increased risk of bleeding.
- Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
- Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2003-31-05
Actual study completion date
2003-31-05
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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