Dose Ranging Study in Elective Total Hip Replacement Surgery
NCT ID: NCT00338897
Last Updated: 2008-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
1090 participants
INTERVENTIONAL
2006-05-31
2007-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
NCT00331838
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
NCT00168818
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
NCT00423319
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery
NCT00697099
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
NCT01203098
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SR123781A
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
sanofi-aventis
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Rud Lassen, MD
Role: STUDY_CHAIR
Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sanofi-Aventis
San Isidro, Buenos Aires, Argentina
Sanofi-Aventis
Sofia, , Bulgaria
Sanofi-Aventis
Providencia, Santiago Metropolitan, Chile
Sanofi-Aventis
Bogotá, , Colombia
Sanofi-Aventis
Prague, , Czechia
Sanofi-Aventis
Denmark, , Denmark
Sanofi-Aventis
Helsinki, , Finland
Sanofi-Aventis
México, , Mexico
Sanofi-Aventis
Oslo, , Norway
Sanofi-Aventis
Warsaw, , Poland
Sanofi-Aventis
Bucharest, , Romania
Sanofi-Aventis
Moscow, , Russia
Sanofi-Aventis
Bromma, , Sweden
Sanofi-Aventis
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lassen MR, Dahl O, Mismetti P, Zielske D, Turpie AG. SR123781A: a new once-daily synthetic oligosaccharide anticoagulant for thromboprophylaxis after total hip replacement surgery: the DRIVE (Dose Ranging Study in Elective Total Hip Replacement Surgery) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1498-504. doi: 10.1016/j.jacc.2008.03.007.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT : 2006-000152-41
Identifier Type: -
Identifier Source: secondary_id
DRI5664
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.