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

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ClinicalTrials.gov Identifier: NCT00902928
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Brief Summary:
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 or disease Intervention/treatment Phase
Venous Thromboembolism Arthroplasty, Replacement, Hip Drug: YM150 Drug: enoxaparin Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1992 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : April 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902928


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

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 )
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
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