Hemotrial Un proyecto de SEHH

Ensayo clínico

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

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Resumen

2017-03-15 04:00:58
2006-003674-96
CV185-036
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
CV185-036

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Bristol Myers Squibb Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Clexane
Sanofi-Aventis Deutschland GmbH Apixaban
BMS-562247-01 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

BMS-562247-01 (

Concentración del fármaco:

mg milligram(s) equal

2.5

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Comparator
Clexane
enoxaparin sodi Solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/ml milligram equal

40 mg/0.4ml

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Film-coated tablet

Oral use
  PLACEBO 2:

Si
Solution for injection

Subcutaneous use

Información General



Enfermedad Trombótica

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 d


To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared tostandard, subcutaneous administration of enoxaparin 40 mg QD for a recommendedminimum period of 6 days, in subjects with acute medical illness. Total VTE is definedas the combination of fatal or nonfatal pulmonary embolism, symptomatic deep veinthrombosis (DVT), and asymptomatic proximal DVT detected by bilateral compressionultrasound.

Efficacy:• To demonstrate that oral administration of apixaban 2.5 mg BID is not inferior tosubcutaneous administration of enoxaparin 40 mg QD for the prevention of total VTEand VTE-related death occurring up to the time of discontinuation of parenteraltherapy.• To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total VTE and all cause death compared to subcutaneous administration of enoxaparin 40 mg QD.• To assess the effect of orally-administered apixaban 2.5 mg BID on the incidence and time to occurrence of symptomatic PE and symptomatic DVT.• To assess the effect of orally-administered apixaban 2.5 mg BID on the rate ofall-cause mortality at 30 and 90 days after randomization.Safety• To demonstrate that orally administered apixaban 2.5 mg BID for 30 days is generally safe and well tolerated in this patient population.

No


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 boweldisease.3) Except for subjects with congestive heart failure or respiratory failure, subjects must have one additional factor including:a) age ? 75b) previous documented VTE or history of VTE for which they received anticoagulation for at least 6 weeksc) cancerd) BMI ? 30 (See Appendix 4 for BMI chart)e) estrogenic hormone therapyf) chronic heart or respiratory failure4) Expected hospitalization of ? 3 days after randomization5) Severely or moderately restricted mobility (i.e. bedridden or limited to chair, walking to bathroom or within room; see section 6.9.1)6) Men and women, of any race, at least 40 years of ageWomen of childbearing potential (WOCBP) must be using an adequate method ofcontraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.

1) WOCBP who are unwilling or unable to use an acceptable method to avoidpregnancy for the entire study period2) WOCBP using a prohibited contraceptive method3) Women who are pregnant or breastfeeding4) Women with a positive pregnancy test on enrollment or prior to investigationalproduct administration5) Subjects with a confirmed VTE6) Subjects with diseases requiring ongoing treatment with a parenteral or oralanticoagulant, e.g. subjects with mechanical valves, warfarin eligible atrial fibrillation7) Subjects with conditions requiring treatment with parenteral or oral antiplatelet agents other than aspirin ? 165 mg/day8) Active liver disease as evidenced by abnormal laboratory test findings (see physical and laboratory findings below)9) Anemia or thrombocytopenia as evidenced by abnormal laboratory test findings (see physical and laboratory findings below)10) Severe renal disease as evidenced by creatinine clearance < 30 mL/min as estimated by the method of Cockcroft and Gault (see Section 6.3.1.2)11) Subjects hospitalized more than 48 hours prior to randomization12) Subjects who are unable to take oral medications13) Subjects who have had surgery in the past 30 days that may be associated with a risk of bleeding14) Subjects who have received anticoagulant prophylaxis for VTE in the past 14 days consisting of more than two doses of enoxaparin or another low molecular weight heparin, more than four doses of unfractionated heparin, or more than two doses of an oral anticoagulant15) Subjects with active bleeding or high risk of bleeding16) Subjects with planned or scheduled invasive procedures during the treatment period17) Subjects in whom in the opinion of the Investigator it is not possible to obtain anadequate bilateral compression ultrasound evaluation18) Subjects with acute shock19) Subjects with a life expectancy < 1 month20) Abnormal hematological findings:• Hemoglobin < 10 g/dL• Platelet count < 100,000/mm21) Abnormal liver function tests:• ALT or AST > 2 X ULN or• bilirubin (direct or total) > 1.5 X ULN (unless in an alternative causative factor[e.g., Gilbert’s syndrome] is identified)22) Known or suspected allergies to enoxaparin or prior heparin-inducedthrombocytopenia23) Use of bevacizumab (Avastin®) therapy within the previous 6 months or planned use during the study period24) Presently receiving oral anticoagulant therapy25) Presently receiving oral antiplatelet therapy other than aspirin at a dose ? 165 mg.26) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study27) Administration of any investigational drug currently or within 30 days prior toplanned enrollment into this study28) Subjects unwilling or unable to comply with study medication instructions including the use of enoxaparin or matching placebo for the recommended minimum treatment duration of 6 days29) Subjects unwilling or unable to comply with study procedures (e.g., bilateralcompression ultrasound) specified in the protocol30) Subjects who have previously been randomized in an experimental study of apixaban

The primary efficacy outcome measure is a composite endpoint of adjudicated total VTE and VTE-related death during 30 days of double-blind treatment, in acutely ill medical subjects during and following hospitalization.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

1
9
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


281

Para estudios internacionales:


2793
7502

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha