Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Tracking Information
Start Date ICMJE | May 2008 |
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Estimated Primary Completion Date | May 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 5, 2008) | Venous Thromboembolic Recurrence or Death [ Time Frame: upon occurrence during study treatment ] |
Change History | Complete list of historical versions of study NCT00633893 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 5, 2008) | Bleeding [ Time Frame: upon occurrence during study treatment ] |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety Study of Apixaban for Extended 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 for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism |
Brief Summary | The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for 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), Placebo 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 | 2430 | ||||||||
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Estimated Completion Date | April 2013 | ||||||||
Estimated Primary Completion Date | May 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, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Korea, Republic of, Mexico, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, South Africa, Spain, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00633893 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CV185-057, EUDRACT: 2007-004953-27 | ||||
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/