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

NCT ID: NCT00206089

Last Updated: 2010-11-15

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thromboembolism

Keywords

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Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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EXANTA

Intervention Type DRUG

Other Intervention Names

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Melagatran/Ximelagatran

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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Argentina Brazil Taiwan Turkey (Türkiye) Austria Belgium Denmark Finland France Germany Hungary Mexico Netherlands Norway Poland Portugal South Africa Spain Sweden Switzerland

References

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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.

Reference Type DERIVED
PMID: 18485453 (View on PubMed)

Other Identifiers

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D4003C00030

Identifier Type: -

Identifier Source: org_study_id