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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.
 
ClinicalTrials.gov Identifier: NCT00338897
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : December 10, 2008
Sponsor:
Information provided by:
Sanofi

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00338897


Locations
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Argentina
Sanofi-Aventis
San Isidro, Buenos Aires, Argentina, 1642
Bulgaria
Sanofi-Aventis
Sofia, Bulgaria, 1715
Chile
Sanofi-Aventis
Providencia, Santiago, Chile
Colombia
Sanofi-Aventis
Santafe de Bogota, Colombia
Czech Republic
Sanofi-Aventis
Praha, Czech Republic, 160 00
Denmark
Sanofi-Aventis
Denmark, Denmark
Finland
Sanofi-Aventis
Helsinki, Finland
Mexico
Sanofi-Aventis
Mexico, Mexico, 04000
Norway
Sanofi-Aventis
Oslo, Norway
Poland
Sanofi-Aventis
Warszawa, Poland
Romania
Sanofi-Aventis
Bucuresti, Romania, 70334
Russian Federation
Sanofi-Aventis
Moscow, Russian Federation, 101000
Sweden
Sanofi-Aventis
Bromma, Sweden
Turkey
Sanofi-Aventis
Istanbul, Turkey, 34394
Sponsors and Collaborators
Sanofi
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00338897     History of Changes
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
Prevention
Arthroplasty
Replacement
Hip
orthopedic surgery
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases