Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB-424323 · 1 trial · 1 indication
Incidence of VTE during the 28-day treatment period, including death due to VTE
| Arm | Type | Description |
|---|---|---|
| SB424323, 500 mg BID | EXPERIMENTAL | - |
| SB424323, 125 mg BID | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SB-424323 | DRUG | 500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days |
| Placebo | DRUG | matching placebo, oral, BID for 28 days |
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 contraindicatio...
SB-424323 is an investigational small molecule being studied for use in arthroplasty and in non-valvular atrial fibrillation in patients at low or intermediate risk for stroke. It is being developed by GSK plc and is currently in Phase 2 clinical development.
SB-424323 is a small molecule being studied for its potential to prevent thromboembolism. It is being evaluated in patients undergoing arthroplasty and in patients with non-valvular atrial fibrillation, where it is being tested in combination with aspirin.
SB-424323 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical development.
SB-424323 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one in arthroplasty and one in atrial fibrillation.
SB-424323 has been studied in two completed Phase 2 trials. The ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST, NCT00041509) enrolled 343 patients undergoing arthroplasty. A second trial (NCT00240643) enrolled 640 patients with non-valvular atrial fibrillation and evaluated SB-424323 in combination with aspirin.
No, SB-424323 is the drug being studied, while TEMPEST is the name of one of its clinical trials. The ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST, NCT00041509) is a Phase 2 study of SB-424323 in patients undergoing arthroplasty.