Dose Ranging Study in Elective Total Hip Replacement Surgery

Sanofi1,090 enrolled

Overview

The primary objective is to: * demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery. The secondary objectives are to: * evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and * to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,090

Conditions

Venous Thromboembolism

Interventions

SR123781ADRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry Exclusion Criteria: * Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization * Known progressive malignant disease * Ischemic stroke in the last 3 months * Myocardial infarction (MI) in the last 3 months * Any major orthopedic surgery in the 3 months prior to study start * Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments) * Treatment with other antithrombotic agents within 7 days prior to surgery

Locations (14)

Sanofi-Aventis

San Isidro, Buenos Aires, Argentina

Sanofi-Aventis

Sofia, Bulgaria

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Outcomes

Primary Outcomes

The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.

Secondary Outcomes

Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)

The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.