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Dose Ranging Study in Elective Total Hip Replacement Surgery

NCT00338897 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1090

Last updated 2008-12-10

No results posted yet for this study

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.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

SR123781A

Sponsors & Collaborators

Principal Investigators

  • Michael Rud Lassen, MD · Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

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

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338897 on ClinicalTrials.gov