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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
Not Enrolling
Both
Venous Thrombosis, Pulmonary Embolism

Thank you

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 HospitalMorristown, New Jersey  07962-1956
Stanford UniversityStanford, California  94305
Lehigh Valley HospitalAllentown, Pennsylvania  18103
North Shore University HospitalManhasset, New York  11030
Staten Island University HospitalStaten Island, New York  10305
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Johns Hopkins University School of MedicineBaltimore, Maryland  21205
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
George Washington UniversityWashington, District of Columbia  20037
Yale University School Of MedicineNew Haven, Connecticut  06520
McGuire VA Medical CenterRichmond, Virginia  23249
Norwalk HospitalNorwalk, Connecticut  06856
Franklin Square HospitalBaltimore, Maryland  21237
Jacksonville Center for Clinical ResearchJacksonville, Florida  32216
Intermountain Medical CenterMurray, Utah  84157
Univ. Of Southern Calif. /Norris Comprehensive Cancer CenterLos Angeles, California  90033
University of Utah Medical CenterSalt Lake City, Utah  84132
Atlanta Institute For Medical Research, IncDecatur, Georgia  30030
South Oklahoma Heart ResearchOklahoma City, Oklahoma  73135
Palmetto Nephrology PaOrangeburg, South Carolina  29118
S. Carolina Pharmaceutical ResearchSpartanburg, South Carolina  29303
University Of Alabama At Birmingham HospitalBirmingham, Alabama  35294
Heart Center Research, LlcHuntsville, Alabama  35801
Arizona Pulmonary Specialists, Ltd.Phoenix, Arizona  85013
Az Pulmonary Specialists LtdScottsdale, Arizona  85258
Fort Smith Lung CenterFort Smith, Arkansas  72901
Scripps Clinic/Scripps Health And Green HospitalLa Jolla, California  92037
Va Long Beach Healthcare SystemLong Beach, California  90822
Dr. Felt Medical OfficeOakland, California  94609
Florida Hospital Celebration HealthCelebration, Florida  34747
Research Alliance, Inc.Clearwater, Florida  33756
Pensacola Lung GroupPensacola, Florida  32504
Indian River Med. Ctr.Vero Beach, Florida  32960
Pulmonary & Critical Care Of AtlantaAtlanta, Georgia  30342
Idaho Falls Infectious Diseases, PllcIdaho Falls, Idaho  83404
West Suburban HospitalOak Park, Illinois  60302
Infectious Disease Of Indiana PscCarmel, Indiana  46032
Cotton-O-Neil Clinical Research CenterTopeka, Kansas  66604
Louisiana State University Health Sciences Center-ShreveportShreveport, Louisiana  71103
Henry Ford Hospital, Transplant InstituteDetriot, Michigan  48202
University Of Missouri-ColumbiaColumbia, Missouri  65212
Mercury Street Medical Group, PllcButte, Montana  59701
Mission Hospital, IncAsheville, North Carolina  28801
The Milton S Hershey Medical Center Of Penn. State Univ.Hershey, Pennsylvania  17033
Texas Health Presbyterian DallasDallas, Texas  75231
Michael E. De Bakey Veteran Affairs Medical CenterHouston, Texas  77030
Sonterra Clinical ResearchSan Antonio, Texas  78205