ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Arthroplasty

Treatments: Drug: SB-424323; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00041509

424323/025

Details and patient eligibility

About

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).

Enrollment: 343 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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343 participants in 3 patient groups, including a placebo group

SB424323, 500 mg BID

Experimental group

Treatment:

Drug: SB-424323

SB424323, 125 mg BID

Experimental group

Treatment:

Drug: SB-424323

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo