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

ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

Sponsors

Lead sponsor: GlaxoSmithKline

Source GlaxoSmithKline
Brief 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).

Overall Status Completed
Start Date January 2002
Completion Date May 2003
Primary Completion Date May 2003
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
VTE 28 day treatment period
Secondary Outcome
Measure Time Frame
types of VTE 28 day treatment period
Enrollment 343
Condition
Intervention

Intervention type: Drug

Intervention name: SB-424323

Description: 500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days

Intervention type: Drug

Intervention name: Placebo

Description: matching placebo, oral, BID for 28 days

Arm group label: Placebo

Eligibility

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.

Gender: All

Minimum age: 35 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Verification Date

May 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: SB424323, 500 mg BID

Arm group type: Experimental

Arm group label: SB424323, 125 mg BID

Arm group type: Experimental

Arm group label: Placebo

Arm group type: Placebo Comparator

Acronym TEMPEST
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov