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 BV
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

July 18, 2006
March 19, 2013
June 2006
August 2007   (final data collection date for primary 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
Not Provided
Complete list of historical versions of study NCT00353678 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Thromboembolism
Drug: YM150
Not Provided
Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kälebo 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1141
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bosnia and Herzegovina,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Italy,   Latvia,   Lithuania,   Norway,   Poland,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden
 
NCT00353678
150-CL-008
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Europe BV
Principal Investigator: Astellas Pharma Europe B.V., Medical Clinical Development Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden
Astellas Pharma Inc
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP