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NCT00902928
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery (ONYX-3)
Tracking Information
Start Date ICMJE | April 2009 |
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Estimated Primary Completion Date | August 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 ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00902928 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 14, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery |
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Official Title ICMJE | 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 |
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 Phase | Phase II, Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 2000 | ||||
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Estimated Completion Date | August 2010 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United 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 ICMJE | NCT00902928 | ||||
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Responsible Party | Disclosure Office Europe, Astellas Pharma Europe BV | ||||
Study ID Numbers ICMJE | 150-CL-040, EudraCT number: 2008-004416-13 | ||||
Study Sponsor ICMJE | Astellas Pharma Inc | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Astellas Pharma Inc |
Source: http://clinicaltrials.gov/