Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Tracking Information
Start Date ICMJE | August 2008 |
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Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 25, 2008) | Venous thromboembolic recurrence or death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: March 20, 2008) | Venous thromboembolic recurrence or death [ Time Frame: upon occurrence during study treatment ] |
Change History | Complete list of historical versions of study NCT00643201 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 25, 2008) | Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE (submitted: March 20, 2008) | Bleeding [ Time Frame: upon occurrence during study treatment ] |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism |
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Official Title ICMJE | A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism |
Brief Summary | The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Venous Thrombosis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 4816 | ||||||||
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Estimated Completion Date | December 2012 | ||||||||
Estimated Primary Completion Date | July 2011 (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, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, South |
Administrative Information
NCT ID ICMJE | NCT00643201 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CV185-056, EUDRACT: 2007-007867-25 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/