Trials / Completed
CompletedNCT00041509
ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 343 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SB-424323 | 500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days |
| DRUG | Placebo | matching placebo, oral, BID for 28 days |
Timeline
- Start date
- 2002-01-01
- Primary completion
- 2003-05-01
- Completion
- 2003-05-01
- First posted
- 2002-07-12
- Last updated
- 2017-05-30
Source: ClinicalTrials.gov record NCT00041509. Inclusion in this directory is not an endorsement.