Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Tracking Information
Start Date ICMJE | December 2007 |
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Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: June 30, 2008) | Composite of VTE (DVT and/or PE) and Death [ Time Frame: up to day 35 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: December 11, 2007) | Composite of VTE (DVT and/or PE) and Death [ Time Frame: +/- 4 days ] |
Change History | Complete list of historical versions of study NCT00571649 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 21, 2007) | Individual components of the composite endpoint and other cardiovascular events. [ Time Frame: 90 + 7 days ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: December 11, 2007) | Individual components of the composite endpoint and other cardiovascular events. [ Time Frame: +/- 4 days ] |
Descriptive Information
Brief Title ICMJE | Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients |
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Official Title ICMJE | MAGELLAN - Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin |
Brief Summary | This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied. |
Detailed Description | Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Venous Thromboembolism |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 8000 | ||||||||
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Estimated Completion Date | July 2010 | ||||||||
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 40 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00571649 | ||||
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Responsible Party | Therapeutic Area Head, Bayer HealthCare AG | ||||
Study ID Numbers ICMJE | 12839, MAGELLAN, EudraCT: 2007-004614-14 | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Investigators ICMJE |
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Information Provided By | Bayer |
Source: http://clinicaltrials.gov/