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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00041509

Acronym

TEMPEST

Enrollment

343

Registered

2002-07-12

Start date

2002-01-31

Completion date

2003-05-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty

Keywords

venous thromboembolism, thromboembolism, pulmonary embolism, deep vein thrombosis

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).

Interventions

DRUGSB-424323

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

DRUGPlacebo

matching placebo, oral, BID for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
VTE	28 day treatment period	Incidence of VTE during the 28-day treatment period, including death due to VTE

Secondary

Measure	Time frame	Description
types of VTE	28 day treatment period	The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE\] and anti-IIa activity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026