Trial | NCT00338897  Report issue

Title

Dose Ranging Study in Elective Total Hip Replacement Surgery
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    heparin ...

  • Study Participants

    1090
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 Started
May 31
2006
Primary Completion
May 31
2007
Study Completion
May 31
2007
Last Update
Dec 10
2008
Estimate

Drug SR123781A

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
No Results Posted