A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
NCT ID: NCT00902928
Last Updated: 2015-10-27
Study Results
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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COMPLETED
PHASE2/PHASE3
1992 participants
INTERVENTIONAL
2009-04-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1. YM150, Dose X, twice daily
YM150
oral
2, YM150, Dose X, once daily
YM150
oral
3. YM150, Dose Y, twice daily
YM150
oral
4. YM150, Dose Y, once daily
YM150
oral
5. Enoxaparin
enoxaparin
SC injection
Interventions
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YM150
oral
enoxaparin
SC injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
* Subject has had an MI or stroke within 3 months before planned hip replacement surgery
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tuscon, Arizona, United States
Little Rock, Arkansas, United States
Long Beach, California, United States
Torrance, California, United States
Aurora, Colorado, United States
DeLand, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
Tamarac, Florida, United States
Meridian, Idaho, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Box Hill, Victoria, Australia
Ringwood East, Victoria, Australia
Windsor, Victoria, Australia
Perth, Western Australia, Australia
Kogarah, , Australia
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Vienna, , Austria
Foča, , Bosnia and Herzegovina
Curitiba, Puerto Rico, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, So Paulo, Brazil
Red Deer, Alberta, Canada
Burlington, Ontario, Canada
Guelph, Ontario, Canada
Newmarket, Ontario, Canada
Thunder Bay, Ontario, Canada
Waterloo, Ontario, Canada
Medellín, Antioquia, Colombia
Bogota, Cundinamarca, Colombia
Floridablanca, Santander Department, Colombia
Barranquilla, , Colombia
Brno, , Czechia
Chomutov, , Czechia
Havlíčkův Brod, , Czechia
Jihlava, , Czechia
Jindřichův Hradec, , Czechia
Klatovy, , Czechia
Liberec, , Czechia
Prague, , Czechia
Třebíč, , Czechia
Copenhagen, , Denmark
Copenhagen, , Denmark
Frederiksberg, , Denmark
Herlev, , Denmark
Hørsholm, , Denmark
Silkeborg, , Denmark
Kohtla-Järve, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Jyväskylä, , Finland
Oulu, , Finland
Mainz, , Germany
Marburg, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Kecskemét, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Hyderabaad, Andhra Pradesh, India
Secunderabad, Andhra Pradesh, India
Secunderabad, Andhra Prasdesh, India
Vadodara, Gujarat, India
Gurgaon, Haryana, India
Jamshedpur, Jharkhand, India
Bangalore, Karnataka, India
Kormangala, Karnataka, India
Mangalore, Karnataka, India
Bhopal, Madhya Pradesh, India
Jaipur, Rajasthan, India
Afula, , Israel
Haifa, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Bologna, , Italy
Milan, , Italy
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
Valmiera, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Gjøvik, , Norway
Kongsvinger, , Norway
Lillehammer, , Norway
Tynset, , Norway
Tønsberg, , Norway
Gmina Końskie, , Poland
Głogów Małopolski, , Poland
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Lublin, , Poland
Opole, , Poland
Otwock, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Timișoara, Timiș County, Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Iași, , Romania
Kazan', , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Yaroslavl, , Russia
Banska Bysterica, , Slovakia
Kosice Saca, , Slovakia
Prešov, , Slovakia
Worcester, Cape Town, South Africa
Benoni, , South Africa
Bryanston, , South Africa
Port Elizabeth, , South Africa
Pretoria, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Castelló, , Spain
Madrid, , Spain
Palma Mallorca, , Spain
Kalmar, , Sweden
Motala, , Sweden
Mölndal, , Sweden
Stockholm, , Sweden
Varberg, , Sweden
Cherkassy, , Ukraine
Ivano-Frankivsk, , Ukraine
Lviv, , Ukraine
Sevastopol, , Ukraine
Epsom, Surrey, United Kingdom
London, , United Kingdom
Northampton, , United Kingdom
Countries
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References
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Eriksson BI, Agnelli G, Gallus AS, Lassen MR, Prins MH, Renfurm RW, Kashiwa M, Turpie AG. Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a randomised phase IIb dose confirmation study (ONYX-3). Thromb Haemost. 2014 Feb;111(2):213-25. doi: 10.1160/TH13-04-0296. Epub 2013 Oct 17.
Other Identifiers
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2008-004416-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
150-CL-040
Identifier Type: -
Identifier Source: org_study_id
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