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


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2009)		Incidence of symptomatic Venous Thromboembolisms and death from all causes [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00902928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 14, 2009)
  • Incidence of all Venous Thromboembolic events [ Time Frame: Until day 12, during the treatment period, follow-up period and entire study period ] [ Designated as safety issue: No ]
  • Incidence of Bleeding events [ Time Frame: During the treatment period, follow-up period and entire study period ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Venous Thromboembolism
  • Arthroplasty, Replacement, Hip
Intervention  ICMJE
  • Drug: YM150
    oral
  • Drug: enoxaparin
    SC injection
Study Arms / Comparison Groups
  • 1. YM150, Dose X, twice daily: Experimental
    Intervention: Drug: YM150
  • 2, YM150, Dose X, once daily: Experimental
    Intervention: Drug: YM150
  • 3. YM150, Dose Y, twice daily: Experimental
    Intervention: Drug: YM150
  • 4. YM150, Dose Y, once daily: Experimental
    Intervention: Drug: YM150
  • 5. Enoxaparin: Active Comparator
    Intervention: Drug: enoxaparin

Recruitment Information

Estimated Enrollment  ICMJE2000
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Medical Clinical Development Department+ 31 (0)71 54 55878
Location Countries  ICMJEUnited States,   Australia,   Austria,   Bosnia and Herzegovina,   Brazil,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   Estonia,   Finland,   Germany,   Hungary,   India,   Israel,   Italy,   Latvia,   Lithuania,   Netherlands,   Norway,   Peru,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00902928
Responsible PartyDisclosure Office Europe, Astellas Pharma Europe BV
Study ID Numbers  ICMJE150-CL-040, EudraCT number: 2008-004416-13
Study Sponsor  ICMJEAstellas Pharma Inc
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Use Central ContactAstellas Pharma Europe BV
Information Provided ByAstellas Pharma Inc