Dose Ranging Study in Elective Total Hip Replacement Surgery (DRIVE)

Sanofi

Status and phase

Completed

Phase 3

Phase 2

Conditions

Venous Thromboembolism

Treatments

Drug: SR123781A

Study type

Interventional

Funder types

Industry

Identifiers

EudraCT : 2006-000152-41

DRI5664

Details and patient eligibility

About

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.

Enrollment

1,090 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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