A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safetyand Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely IllMedical Subjects During and Following Hospitalization.ADOPT: Apixaban Dosing to Optimize Protection from ThrombosisAnd Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date 27-Feb-2007).Estudio multicéntrico, fase III, aleatorizado, doble ciego, de brazos paralelos para evaluar la eficacia y seguridad de apixaban para la profilaxis de tromboembolismo venoso en pacientes médicos con enfermedad aguda durante y después de la hospitalizaciónADOPT: tratamiento con apixaban para optimizar la protección contra la trombosisEnmienda 01 para estudio farmacogenético en sangre específica de centro, versión 2.0 de fecha 27-Feb-2007 - ADOPT

Bristol Myers Squibb0 sites7,502 target enrollmentMarch 5, 2010

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Total Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT.Una Enfermedad Tromboembólica Venosa (ETV) total se define como una combinación de embolismo pulmonar mortal y no-mortal, Trombosis Venosa Profunda (TVP) sintomática y TVP proximal asintomática
Sponsor: Bristol Myers Squibb
Enrollment: 7502
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

March 5, 2010

End Date

May 18, 2011

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Subjects must be willing and able to give written informed consent. Consent to participate in the study must be obtained prior to screening.
•2\) Subjects hospitalized due to congestive heart failure, acute respiratory failure or with infection (without septic shock), acute rheumatic disorder, or inflammatory bowel
•3\) Except for subjects with congestive heart failure or respiratory failure, subjects must have one additional factor including:
•a) age \= 75
•b) previous documented VTE or history of VTE for which they received anticoagulation for at least 6 weeks
•d) BMI \= 30 (See Appendix 4 for BMI chart)
•e) estrogenic hormone therapy
•f) chronic heart or respiratory failure
•4\) Expected hospitalization of \= 3 days after randomization
•5\) Severely or moderately restricted mobility (i.e. bedridden or limited to chair, walking to bathroom or within room; see section 6\.9\.1\)

•1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
•pregnancy for the entire study period
•2\) WOCBP using a prohibited contraceptive method
•3\) Women who are pregnant or breastfeeding
•4\) Women with a positive pregnancy test on enrollment or prior to investigational
•product administration
•5\) Subjects with a confirmed VTE
•6\) Subjects with diseases requiring ongoing treatment with a parenteral or oral
•anticoagulant, e.g. subjects with mechanical valves, warfarin eligible atrial fibrillation
•7\) Subjects with conditions requiring treatment with parenteral or oral antiplatelet agents other than aspirin \= 165 mg/day