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Completed

NCT Number: NCT00041509

ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

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).

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Key information

Conditions

Arthroplasty Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-424323

Drug

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

Placebo

Drug

matching placebo, oral, BID for 28 days

Primary outcomes

  1. VTE

    Time frame: 28 day treatment period

    Incidence of VTE during the 28-day treatment period, including death due to VTE

Secondary outcomes

  1. types of VTE

    Time frame: 28 day treatment period

    The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: TEMPEST

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Jul 12, 2002
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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