Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events (EXTEND)

November 11, 2010 updated by: AstraZeneca

The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.

This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

3300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Leoben, Austria
        • Research Site
      • Neunkirchen, Austria
        • Research Site
      • Neustadt, Austria
        • Research Site
      • St Johann in Tirol, Austria
        • Research Site
      • Viborg, Austria
        • Research Site
      • Wels, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
  • Denmark
      • Arhus, Denmark
        • Research Site
      • Glostrup, Denmark
        • Research Site
      • Hellerup, Denmark
        • Research Site
      • Herlev, Denmark
        • Research Site
      • Hillerod, Denmark
        • Research Site
      • Holstebro, Denmark
        • Research Site
      • Horsholm, Denmark
        • Research Site
      • Hvidovre, Denmark
        • Research Site
      • Silkeborg, Denmark
        • Research Site
      • Vejle, Denmark
        • Research Site
  • Finland
      • Hus, Finland
        • Research Site
      • Jyvaskyla, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Oys, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • France
      • Amiens, France
        • Research Site
      • Annecy, France
        • Research Site
      • Caen, France
        • Research Site
      • Creteil, France
        • Research Site
      • Le Kremlin Bicetre, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Nice Cedex 1, France
        • Research Site
      • Paris, France
        • Research Site
      • Saint Etienne, France
        • Research Site
  • Germany
      • Bad Mergentheim, Germany
        • Research Site
      • Dusseldorf, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Garmisch-Partenkirchen, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Rheinfelden, Germany
        • Research Site
      • Sommerfeld, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Gyzr, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Székesthérvár, Hungary
        • Research Site
  • Mexico
      • Estado de Mexico, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • Mexico Distrito Federal, Mexico
        • Research Site
  • Netherlands
      • Assen, Netherlands
        • Research Site
      • Breda, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Hilversum, Netherlands
        • Research Site
      • Leeuwarden, Netherlands
        • Research Site
      • Sittard, Netherlands
        • Research Site
      • Zaandam, Netherlands
        • Research Site
      • Zwolle, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Bodo, Norway
        • Research Site
      • Drammen, Norway
        • Research Site
      • Elverum, Norway
        • Research Site
      • Gjettum, Norway
        • Research Site
      • Hagavik, Norway
        • Research Site
      • Kongsberg, Norway
        • Research Site
      • Kongsvinger, Norway
        • Research Site
      • Larvik, Norway
        • Research Site
      • Levanger, Norway
        • Research Site
      • Lillehammer, Norway
        • Research Site
      • Nordbyhagen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Skien, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
      • Ålesund, Norway
        • Research Site
  • Poland
      • Biaystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Chojnice, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Od, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wrocraw, Poland
        • Research Site
  • Portugal
      • Barreiro, Portugal
        • Research Site
      • Cascais, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Parede, Portugal
        • Research Site
      • Setúbal, Portugal
        • Research Site
      • Torres Vedras, Portugal
        • Research Site
      • Vila Franca de Xira, Portugal
        • Research Site
  • South Africa
      • Durban, South Africa
        • Research Site
      • Gauteng, South Africa
        • Research Site
      • Sandton, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Orense, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
  • Sweden
      • Boras, Sweden
        • Research Site
      • Falköping, Sweden
        • Research Site
      • Falun, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Jönköping, Sweden
        • Research Site
      • Kalmar, Sweden
        • Research Site
      • Kungalv, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Mölndal, Sweden
        • Research Site
      • Skövde, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uddevalla, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Örebro, Sweden
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
      • Bern, Switzerland
        • Research Site
      • Genève, Switzerland
        • Research Site
      • Lugano, Switzerland
        • Research Site
      • Luzem, Switzerland
        • Research Site
      • Zurich, Switzerland
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent,
  • Female or male aged 18 years and over
  • Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture.

Exclusion Criteria:

  • History of heparin-induced thrombocytopenia
  • Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency.
  • Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Non-inferiority for the prevention of VTE or VTE related death

Secondary Outcome Measures

Outcome Measure
Safety
Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 11, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4003C00030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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