Study Stopped
Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.
Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
EXTEND
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.
1 other identifier
interventional
3,300
16 countries
125
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2005
Shorter than P25 for phase_3
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedNovember 15, 2010
November 1, 2010
11 months
September 13, 2005
November 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-inferiority for the prevention of VTE or VTE related death
Secondary Outcomes (2)
Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
Safety
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (125)
Research Site
Graz, Austria
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Innsbruck, Austria
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Leoben, Austria
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Neunkirchen, Austria
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Neustadt, Austria
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Sankt Johann in Tirol, Austria
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Viborg, Austria
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Vienna, Austria
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Wels, Austria
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Aarhus, Denmark
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Glostrup Municipality, Denmark
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Hellerup, Denmark
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Herlev, Denmark
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Hillerød, Denmark
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Holstebro, Denmark
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Hvidovre, Denmark
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Hørsholm, Denmark
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Silkeborg, Denmark
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Vejle, Denmark
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Hus, Finland
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Jyväskylä, Finland
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Kuopio, Finland
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Oys, Finland
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Tampere, Finland
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Turku, Finland
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Amiens, France
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Annecy, France
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Caen, France
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Créteil, France
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Le Kremlin-Bicêtre, France
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Montpellier, France
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Nice, France
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Paris, France
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Saint-Etienne, France
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Bad Mergentheim, Germany
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Düsseldorf, Germany
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Essen, Germany
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Frankfurt, Germany
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Garmisch-Partenkirchen, Germany
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Halle, Germany
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Rheinfelden, Germany
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Sommerfeld, Germany
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Wiesbaden, Germany
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Budapest, Hungary
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Gyula, Hungary
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Gyzr, Hungary
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Kecskemét, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Székesthérvár, Hungary
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Estado de México, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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Assen, Netherlands
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Breda, Netherlands
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Groningen, Netherlands
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Hilversum, Netherlands
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Leeuwarden, Netherlands
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Sittard, Netherlands
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Zaandam, Netherlands
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Zwolle, Netherlands
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Ålesund, Norway
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Bergen, Norway
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Bodø, Norway
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Drammen, Norway
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Elverum, Norway
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Gjettum, Norway
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Hagavik, Norway
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Kongsberg, Norway
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Kongsvinger, Norway
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Larvik, Norway
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Levanger, Norway
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Lillehammer, Norway
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Nordbyhagen, Norway
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Oslo, Norway
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Skien, Norway
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Stavanger, Norway
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Trondheim, Norway
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Biaystok, Poland
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Bydgoszcz, Poland
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Chojnice, Poland
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Gdansk, Poland
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Lublin, Poland
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Od, Poland
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Warsaw, Poland
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Wrocraw, Poland
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Barreiro, Portugal
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Cascais, Portugal
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Lisbon, Portugal
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Parede, Portugal
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Setúbal, Portugal
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Torres Vedras, Portugal
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Vila Franca de Xira, Portugal
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Durban, South Africa
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Gauteng, South Africa
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Sandton, South Africa
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Barcelona, Spain
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Madrid, Spain
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Ourense, Spain
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Santander, Spain
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Valencia, Spain
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Borås, Sweden
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Falköping, Sweden
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Falun, Sweden
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Gothenburg, Sweden
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Jönköping, Sweden
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Kalmar, Sweden
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Kungälv, Sweden
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Linköping, Sweden
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Lund, Sweden
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Mölndal, Sweden
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Örebro, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Uddevalla, Sweden
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Uppsala, Sweden
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Basel, Switzerland
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Bern, Switzerland
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Geneva, Switzerland
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Lugano, Switzerland
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Luzem, Switzerland
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Zurich, Switzerland
Related Publications (1)
Agnelli G, Eriksson BI, Cohen AT, Bergqvist D, Dahl OE, Lassen MR, Mouret P, Rosencher N, Andersson M, Bylock A, Jensen E, Boberg B; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res. 2009;123(3):488-97. doi: 10.1016/j.thromres.2008.02.017. Epub 2008 May 15.
PMID: 18485453DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
September 1, 2005
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
November 15, 2010
Record last verified: 2010-11