ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

Arthroplasty Clinical Trial

— TEMPEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041509
• Other study ID #: 424323/025
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2002
• Last updated: May 24, 2017
• Start date: January 2002
• Est. completion date: May 2003

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty
• Thromboembolism

Intervention

Drug:
• SB-424323
500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
• Placebo
matching placebo, oral, BID for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE	Incidence of VTE during the 28-day treatment period, including death due to VTE	28 day treatment period
Secondary	types of VTE	The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity	28 day treatment period