Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)

NCT ID: NCT00353678

Last Updated: 2013-03-21

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.

Detailed Description

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Conditions

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Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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YM150

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scheduled for elective primary hip replacement
* Age 18 years or over
* Written informed consent obtained

Exclusion Criteria

* Documented history or considered at increased risk of venous thromboembolism
* Subjects considered at increased risk of bleeding
* Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
* Concomitant use of anticoagulants/ antiplatelet agents
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astellas Pharma Europe B.V., Medical Clinical Development

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden

Locations

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Innsbruck, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Foča, , Bosnia and Herzegovina

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Sarajevo, , Bosnia and Herzegovina

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Tuzla, , Bosnia and Herzegovina

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Brno, , Czechia

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Kladno, , Czechia

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Prague, , Czechia

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Třebíč, , Czechia

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Copenhagen, , Denmark

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Herlev, , Denmark

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Hørsholm, , Denmark

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Silkeborg, , Denmark

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Jyväskylä, , Finland

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Oulu, , Finland

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Berlin, , Germany

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Frankfurt am Main, , Germany

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Halle, , Germany

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Kremmen OT Somerfeld, , Germany

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Markgröningen, , Germany

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Schwandorf in Bayern, , Germany

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Athens, , Greece

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Melíssia, , Greece

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Bologna, , Italy

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Milan, , Italy

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Milan, , Italy

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Parma, , Italy

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Pavia, , Italy

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Pietra Ligure, , Italy

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Reggio Emilia, , Italy

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Rozzano, , Italy

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S. Donato Milanese, , Italy

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Udine, , Italy

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Riga, , Latvia

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Riga, , Latvia

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Valmiera, , Latvia

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Elverum, , Norway

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Trondheim, , Norway

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Tynset, , Norway

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Bialystok, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Chelyabinsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Orenburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Volgograd, , Russia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Subotica, , Serbia

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Banska Bysterica, , Slovakia

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Ružomberok, , Slovakia

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Cantoria, , Spain

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Castellon, , Spain

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Cáceres, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Falköping, , Sweden

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Gothenburg, , Sweden

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Kalmar, , Sweden

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Motala, , Sweden

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Stockholm, , Sweden

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Countries

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Austria Bosnia and Herzegovina Czechia Denmark Finland Germany Greece Italy Latvia Lithuania Norway Poland Russia Serbia Slovakia Spain Sweden

References

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Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kalebo P, Wetherill G, Wilpshaar JW, Meems L; ONYX-2 STUDY GROUP. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2). J Thromb Haemost. 2010 Apr;8(4):714-21. doi: 10.1111/j.1538-7836.2010.03748.x. Epub 2010 Jan 17.

Reference Type BACKGROUND
PMID: 20088935 (View on PubMed)

Other Identifiers

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150-CL-008

Identifier Type: -

Identifier Source: org_study_id

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