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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00338897
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : December 10, 2008
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: SR123781A Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1090 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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

Secondary Outcome Measures :
  1. Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00338897

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San Isidro, Buenos Aires, Argentina, 1642
Sofia, Bulgaria, 1715
Providencia, Santiago, Chile
Santafe de Bogota, Colombia
Czech Republic
Praha, Czech Republic, 160 00
Denmark, Denmark
Helsinki, Finland
Mexico, Mexico, 04000
Oslo, Norway
Warszawa, Poland
Bucuresti, Romania, 70334
Russian Federation
Moscow, Russian Federation, 101000
Bromma, Sweden
Istanbul, Turkey, 34394
Sponsors and Collaborators
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Study Chair: Michael Rud Lassen, MD Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00338897    
Other Study ID Numbers: DRI5664
EudraCT : 2006-000152-41
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: December 10, 2008
Last Verified: December 2008
Keywords provided by Sanofi:
Venous Thromboembolism
orthopedic surgery
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases