Dose Ranging Study in Elective Total Hip Replacement Surgery (DRIVE)
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|ClinicalTrials.gov Identifier: NCT00338897|
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : December 10, 2008
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1090 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
- The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.
- Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
- 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.
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
|San Isidro, Buenos Aires, Argentina, 1642|
|Sofia, Bulgaria, 1715|
|Providencia, Santiago, Chile|
|Santafe de Bogota, Colombia|
|Praha, Czech Republic, 160 00|
|Mexico, Mexico, 04000|
|Bucuresti, Romania, 70334|
|Moscow, Russian Federation, 101000|
|Istanbul, Turkey, 34394|
|Study Chair:||Michael Rud Lassen, MD||Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark|