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

March 19, 2013 updated by: Astellas Pharma Inc

Direct Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement.---A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Enoxaparin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1141

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
      • Vienna, Austria, 1090
      • Vienna, Austria, 1130
  • Bosnia and Herzegovina
      • Foca, Bosnia and Herzegovina, 73300
      • Sarajevo, Bosnia and Herzegovina, 71000
      • Tuzla, Bosnia and Herzegovina, 75000
  • Czech Republic
      • Brno, Czech Republic, 66250
      • Kladno, Czech Republic, 27259
      • Praha, Czech Republic, 18000
      • Trebic, Czech Republic, 67401
  • Denmark
      • Copenhagen, Denmark, 2300
      • Herlev, Denmark, 2730
      • Horsholm, Denmark, 2970
      • Silkeborg, Denmark, 8600
  • Finland
      • Jyvaskyla, Finland, 40620
      • Oulu, Finland, 90220
  • Germany
      • Berlin, Germany, 12157
      • Frankfurt am Main, Germany, 60528
      • Halle, Germany, 06112
      • Kremmen OT Somerfeld, Germany, 16766
      • Markgroningen, Germany, 71706
      • Schwandorf, Germany, 92421
  • Greece
      • Athens, Greece, 166 73
      • Melissia, Greece, 151 27
  • Italy
      • Bologna, Italy, 40136
      • Milano, Italy, 20162
      • Milano, Italy, 20123
      • Parma, Italy, 43100
      • Pavia, Italy, 27100
      • Pietra Ligure, Italy, 17027
      • Reggio Emilia, Italy, 42100
      • Rozzano, Italy, 20089
      • S. Donato Milanese, Italy, 20097
      • Udine, Italy, 33100
  • Latvia
      • Riga, Latvia, LV 1004
      • Riga, Latvia, LV 1005
      • Valmiera, Latvia, 4201
  • Lithuania
      • Kaunas, Lithuania, LT-50009
      • Vilnius, Lithuania, LT-04130
  • Norway
      • Elverum, Norway, 2409
      • Trondheim, Norway, 7006
      • Tynset, Norway, 2500
  • Poland
      • Bialystok, Poland, 15-276
      • Katowice, Poland, 40-635
      • Krakow, Poland, 31-826
      • Lublin, Poland, 20-718
      • Lublin, Poland, 20-951
      • Warszawa, Poland, 00-909
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454026
      • Moscow, Russian Federation, 119049
      • Moscow, Russian Federation, 111539
      • Moscow, Russian Federation, 129327
      • Moscow, Russian Federation, 117869
      • Nizhniy Novgorod, Russian Federation, 603155
      • Orenburg, Russian Federation, 460000
      • Saint Petersburg, Russian Federation, 194291
      • Samara, Russian Federation, 443095
      • St Petersburg, Russian Federation, 195067
      • Volgograd, Russian Federation, 400040
  • Serbia
      • Belgrade, Serbia, 11000
      • Kragujevac, Serbia, 34000
      • Nis, Serbia, 18000
      • Novi Sad, Serbia, 21000
      • Subotica, Serbia, 24000
  • Slovakia
      • Banska Bysterica, Slovakia, 974 01
      • Ruzomberok, Slovakia, 034 26
  • Spain
      • Caceres, Spain, 10003
      • Cantoria, Spain, 39120
      • Castellon, Spain, 12004
      • Madrid, Spain, 28006
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28035
      • Valencia, Spain, 46010
  • Sweden
      • Falkoping, Sweden, 52185
      • Goteborg, Sweden, 41685
      • Kalmar, Sweden, 39185
      • Motala, Sweden, 59185
      • Stockholm, Sweden, 11883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of total venous thromboembolism (VTE) during hospitalization phase
Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major

Secondary Outcome Measures

Outcome Measure
Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
Symptomatic VTE
Rate of total VTE
Death due to any cause during treatment
Incidence of the bleeding types:
Major or clinically relevant non-major bleeding, Major bleeding,
Clinically relevant non-major bleeding, Minor bleeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Europe B.V.

Investigators

  • Principal Investigator: Astellas Pharma Europe B.V., Medical Clinical Development, Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (Estimate)

July 19, 2006

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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