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A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery (ONYX-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT00902928
First received: April 30, 2009
Last updated: October 5, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

Condition Intervention Phase
Venous Thromboembolism
Arthroplasty, Replacement, Hip
Drug: YM150
Drug: enoxaparin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of symptomatic Venous Thromboembolisms and death from all causes [ Time Frame: 12 days ]

Secondary Outcome Measures:
  • Incidence of all Venous Thromboembolic events [ Time Frame: Until day 12, during the treatment period, follow-up period and entire study period ]
  • Incidence of Bleeding events [ Time Frame: During the treatment period, follow-up period and entire study period ]

Enrollment: 1992
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. YM150, Dose X, twice daily Drug: YM150
oral
Experimental: 2, YM150, Dose X, once daily Drug: YM150
oral
Experimental: 3. YM150, Dose Y, twice daily Drug: YM150
oral
Experimental: 4. YM150, Dose Y, once daily Drug: YM150
oral
Active Comparator: 5. Enoxaparin Drug: enoxaparin
SC injection

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is scheduled for elective hip replacement surgery

Exclusion Criteria:

  • Subject has active bleeding or any condition associated with increased risk of bleeding
  • Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
  • Subject has had an MI or stroke within 3 months before planned hip replacement surgery
  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: NCT00902928

  Show 156 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT00902928     History of Changes
Other Study ID Numbers: 150-CL-040
2008-004416-13 ( EudraCT Number )
Study First Received: April 30, 2009
Last Updated: October 5, 2015

Keywords provided by Astellas Pharma Inc:
Elective hip replacement surgery
Factor Xa
Venous Thromboembolism
Thrombosis
Anticoagulants
Prevention
YM150

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Darexaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on April 27, 2017