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

  Show 79 Study Locations
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
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014