Dose Ranging Study in Elective Total Hip Replacement Surgery

Venous Thromboembolism Clinical Trial

— DRIVE  

Official title:

A Multicenter, Randomized, Double-Blind, Double Dummy, Parallel Group, Dose Ranging Study of Subcutaneous SR123781A With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338897
• Other study ID #: DRI5664
• Secondary ID: EudraCT : 2006-0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 19, 2006
• Last updated: December 9, 2008
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of HealthRomania: National Medicines AgencyTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1090
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• SR123781A

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	San Isidro	Buenos Aires
Bulgaria	Sanofi-Aventis	Sofia
Chile	Sanofi-Aventis	Providencia	Santiago
Colombia	Sanofi-Aventis	Santafe de Bogota
Czech Republic	Sanofi-Aventis	Praha
Denmark	Sanofi-Aventis	Denmark
Finland	Sanofi-Aventis	Helsinki
Mexico	Sanofi-Aventis	Mexico
Norway	Sanofi-Aventis	Oslo
Poland	Sanofi-Aventis	Warszawa
Romania	Sanofi-Aventis	Bucuresti
Russian Federation	Sanofi-Aventis	Moscow
Sweden	Sanofi-Aventis	Bromma
Turkey	Sanofi-Aventis	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Argentina,  Bulgaria,  Chile,  Colombia,  Czech Republic,  Denmark,  Finland,  Mexico,  Norway,  Poland,  Romania,  Russian Federation,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.
Secondary	Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
Secondary	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.

External Links

•   Link