Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
NCT00643201
ABOUT THIS STUDY
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- Men and women ≥ 18 years of age
- Clinical diagnosis of DVT or PE
- Contraindications for enoxaparin or warfarin
- Active bleeding or high risk for serious bleeding
- Short life expectancy
- Uncontrolled high blood pressure
- Significantly impaired kidney or liver function
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism | |||
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 | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Venous Thrombosis | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 5614 | |||
Original Estimated Enrollment ICMJE | 5000 | |||
Actual Study Completion Date ICMJE | March 2013 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | 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 Africa, Spain, Ukraine, United Kingdom, United States | |||
Removed Location Countries | Taiwan, Turkey | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00643201 | |||
Other Study ID Numbers ICMJE | CV185-056 EUDRACT: 2007-007867-25 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Bristol-Myers Squibb | |||
Study Sponsor ICMJE | Bristol-Myers Squibb | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |