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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00206089
Other study ID # D4003C00030
Secondary ID
Status Terminated
Phase Phase 3
First received September 13, 2005
Last updated November 11, 2010
Start date September 2005
Est. completion date August 2006

Study information

Verified date November 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
EXANTA


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Hungary,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  South Africa,  Spain,  Sweden,  Switzerland, 

Outcome

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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