A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Phase 3
40 Years
N/A
40 Years
N/A
Not Enrolling
Both
Venous Thrombosis, Pulmonary Embolism
Both
Venous Thrombosis, Pulmonary Embolism
Trial Information
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Inclusion Criteria:
- men and non-pregnant, non-breastfeeding women
- 40 years or older
- hospitalized with congestive heart failure or acute respiratory failure
- infection (without septic shock)
- acute rheumatic disorder
- inflammatory bowel disease
Exclusion Criteria:
- patients with VTE
- active bleeding or at high risk of bleeding
- unable to take oral medication
- with diseases requiring ongoing treatment with anticoagulants or antiplatelets other
than aspirin at a dose ≤ 165 mg/day.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Composite of venous thromboembolism (VTE) and VTE-related death
Outcome Time Frame:
during 30 days of double-blind treatment
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CV185-036
NCT ID:
NCT00457002
Start Date:
June 2007
Completion Date:
May 2011
Related Keywords:
- Venous Thrombosis
- Pulmonary Embolism
- Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients
- Embolism
- Pulmonary Embolism
- Thrombosis
- Venous Thrombosis
- Venous Thromboembolism
Name | Location |
|---|---|
| Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
| Stanford University | Stanford, California 94305 |
| Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Staten Island University Hospital | Staten Island, New York 10305 |
| Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
| Johns Hopkins University School of Medicine | Baltimore, Maryland 21205 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
| George Washington University | Washington, District of Columbia 20037 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| McGuire VA Medical Center | Richmond, Virginia 23249 |
| Norwalk Hospital | Norwalk, Connecticut 06856 |
| Franklin Square Hospital | Baltimore, Maryland 21237 |
| Jacksonville Center for Clinical Research | Jacksonville, Florida 32216 |
| Intermountain Medical Center | Murray, Utah 84157 |
| Univ. Of Southern Calif. /Norris Comprehensive Cancer Center | Los Angeles, California 90033 |
| University of Utah Medical Center | Salt Lake City, Utah 84132 |
| Atlanta Institute For Medical Research, Inc | Decatur, Georgia 30030 |
| South Oklahoma Heart Research | Oklahoma City, Oklahoma 73135 |
| Palmetto Nephrology Pa | Orangeburg, South Carolina 29118 |
| S. Carolina Pharmaceutical Research | Spartanburg, South Carolina 29303 |
| University Of Alabama At Birmingham Hospital | Birmingham, Alabama 35294 |
| Heart Center Research, Llc | Huntsville, Alabama 35801 |
| Arizona Pulmonary Specialists, Ltd. | Phoenix, Arizona 85013 |
| Az Pulmonary Specialists Ltd | Scottsdale, Arizona 85258 |
| Fort Smith Lung Center | Fort Smith, Arkansas 72901 |
| Scripps Clinic/Scripps Health And Green Hospital | La Jolla, California 92037 |
| Va Long Beach Healthcare System | Long Beach, California 90822 |
| Dr. Felt Medical Office | Oakland, California 94609 |
| Florida Hospital Celebration Health | Celebration, Florida 34747 |
| Research Alliance, Inc. | Clearwater, Florida 33756 |
| Pensacola Lung Group | Pensacola, Florida 32504 |
| Indian River Med. Ctr. | Vero Beach, Florida 32960 |
| Pulmonary & Critical Care Of Atlanta | Atlanta, Georgia 30342 |
| Idaho Falls Infectious Diseases, Pllc | Idaho Falls, Idaho 83404 |
| West Suburban Hospital | Oak Park, Illinois 60302 |
| Infectious Disease Of Indiana Psc | Carmel, Indiana 46032 |
| Cotton-O-Neil Clinical Research Center | Topeka, Kansas 66604 |
| Louisiana State University Health Sciences Center-Shreveport | Shreveport, Louisiana 71103 |
| Henry Ford Hospital, Transplant Institute | Detriot, Michigan 48202 |
| University Of Missouri-Columbia | Columbia, Missouri 65212 |
| Mercury Street Medical Group, Pllc | Butte, Montana 59701 |
| Mission Hospital, Inc | Asheville, North Carolina 28801 |
| The Milton S Hershey Medical Center Of Penn. State Univ. | Hershey, Pennsylvania 17033 |
| Texas Health Presbyterian Dallas | Dallas, Texas 75231 |
| Michael E. De Bakey Veteran Affairs Medical Center | Houston, Texas 77030 |
| Sonterra Clinical Research | San Antonio, Texas 78205 |
