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Dose Ranging Study in Elective Total Hip Replacement Surgery

NCT ID: NCT00338897

Last Updated: 2008-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1090 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism

Keywords

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Venous Thromboembolism Prevention Arthroplasty Replacement Hip orthopedic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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SR123781A

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Michael Rud Lassen, MD

Role: STUDY_CHAIR

Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark

Locations

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Sanofi-Aventis

San Isidro, Buenos Aires, Argentina

Site Status

Sanofi-Aventis

Sofia, , Bulgaria

Site Status

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Site Status

Sanofi-Aventis

Bogotá, , Colombia

Site Status

Sanofi-Aventis

Prague, , Czechia

Site Status

Sanofi-Aventis

Denmark, , Denmark

Site Status

Sanofi-Aventis

Helsinki, , Finland

Site Status

Sanofi-Aventis

México, , Mexico

Site Status

Sanofi-Aventis

Oslo, , Norway

Site Status

Sanofi-Aventis

Warsaw, , Poland

Site Status

Sanofi-Aventis

Bucharest, , Romania

Site Status

Sanofi-Aventis

Moscow, , Russia

Site Status

Sanofi-Aventis

Bromma, , Sweden

Site Status

Sanofi-Aventis

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Brazil Croatia Argentina Bulgaria Chile Colombia Czechia Denmark Finland Mexico Norway Poland Romania Russia Sweden Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 18402906 (View on PubMed)

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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EudraCT : 2006-000152-41

Identifier Type: -

Identifier Source: secondary_id

DRI5664

Identifier Type: -

Identifier Source: org_study_id