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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00353678
First received: July 18, 2006
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Thromboembolism
Drug: YM150
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 1141
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353678

  Hide Study Locations
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, 20123
Milano, Italy, 20162
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, 117869
Moscow, Russian Federation, 129327
Moscow, Russian Federation, 119049
Moscow, Russian Federation, 111539
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, 28035
Madrid, Spain, 28040
Madrid, Spain, 28046
Madrid, Spain, 28006
Valencia, Spain, 46010
Sweden
Falkoping, Sweden, 52185
Goteborg, Sweden, 41685
Kalmar, Sweden, 39185
Motala, Sweden, 59185
Stockholm, Sweden, 11883
Sponsors and Collaborators
Astellas Pharma Inc
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
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00353678     History of Changes
Other Study ID Numbers: 150-CL-008
Study First Received: July 18, 2006
Last Updated: March 19, 2013
Health Authority: Austria: Ethikkommission
Bosnia: Ministry of Health and Social Security
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Astellas Pharma Inc:
Hip replacement
Arthroplasty
Prevention
Thromboembolism
Treatment outcomes
Arthroplasty, replacement, hip

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on July 24, 2014