Thromboembolism Clinical Trial
— EXTENDOfficial title:
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.
Verified date | November 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3300 |
Est. completion date | August 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | Research Site | 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 | |
Belgium | Research Site | Brussels | |
Belgium | Research Site | Gent | |
Belgium | Research Site | Leuven | |
Denmark | Research Site | 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 | |
Finland | Research Site | Hus | |
Finland | Research Site | Jyvaskyla | |
Finland | Research Site | Kuopio | |
Finland | Research Site | Oys | |
Finland | Research Site | Tampere | |
Finland | Research Site | Turku | |
France | Research Site | 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 | |
Germany | Research Site | 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 | |
Hungary | Research Site | 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 | |
Mexico | Research Site | Estado de Mexico | |
Mexico | Research Site | Guadalajara | |
Mexico | Research Site | Mexico Distrito Federal | |
Netherlands | Research Site | 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 | |
Norway | Research Site | Ålesund | |
Norway | Research Site | 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 | |
Poland | Research Site | 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 | |
Portugal | Research Site | 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 | |
South Africa | Research Site | Durban | |
South Africa | Research Site | Gauteng | |
South Africa | Research Site | Sandton | |
Spain | Research Site | Barcelona | |
Spain | Research Site | Madrid | |
Spain | Research Site | Orense | |
Spain | Research Site | Santander | |
Spain | Research Site | Valencia | |
Sweden | Research Site | 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 | Örebro | |
Sweden | Research Site | Skövde | |
Sweden | Research Site | Stockholm | |
Sweden | Research Site | Uddevalla | |
Sweden | Research Site | Uppsala | |
Switzerland | Research Site | Basel | |
Switzerland | Research Site | Bern | |
Switzerland | Research Site | Genève | |
Switzerland | Research Site | Lugano | |
Switzerland | Research Site | Luzem | |
Switzerland | Research Site | Zurich |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Mexico, Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-inferiority for the prevention of VTE or VTE related death | |||
Secondary | Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion. | |||
Secondary | Safety |
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