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Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD),Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixabanin Subjects Undergoing Elective Total Knee Replacement Surgery.And Pharmacogenetics Blood Sample Amendment 01 (Version 2.0, Date 31-Jan-2007)Revised Protocol 01: Incorporates Amendment 02 dated 18-Apr-2007Estudio multicéntrico, aleatorizado, doble ciego, con control activo (Enoxaparina 40 mg. una vez al día) y de grupos paralelos, fase III, para evaluar la eficacia y seguridad de Apixaban en pacientes sometidos a cirugía programada para la implantación de prótesis completa de rodillaY enmienda para muestras de sangre farmacogenéticas (Versión 2.0, de fecha 31-Ene-2007)Protocolo revisado 01: Incorpora enmienda 2 fechado 18- Apr-2007

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Resumen

2017-03-15 04:03:22
2006-006896-19
CV185-047
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD),Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixabanin Subjects Undergoing Elective Total Knee Replacement Surgery.And Pharmacogenetics Blood Sample Amendment 01 (Version 2.0, Date 31-Jan-2007)Revised Protocol 01: Incorporates Amendment 02 dated 18-Apr-2007Estudio multicéntrico, aleatorizado, doble ciego, con control activo (Enoxaparina 40 mg. una vez al día) y de grupos paralelos, fase III, para evaluar la eficacia y seguridad de Apixaban en pacientes sometidos a cirugía programada para la implantación de prótesis completa de rodillaY enmienda para muestras de sangre farmacogenéticas (Versión 2.0, de fecha 31-Ene-2007)Protocolo revisado 01: Incorpora enmienda 2 fechado 18- Apr-2007
The ADVANCE - 2 Study
CV185-047

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

Venous Thromboembolic EventsEventos Tromboembólicos Venosos


To demonstrate that oral apixaban 2.5 mg BID is superior to subcutaneous (SC)enoxaparin 40 mg QD in reducing the event rate on the composite endpoint ofadjudicated asymptomatic and symptomatic DVT, non-fatal PE and all cause deaththrough Day 12 of double-blind treatment in subjects undergoing elective unilateral or same day bilateral knee replacement surgery.

To demonstrate that oral apixaban 2.5 mg BID is non-inferior to subcutaneous (SC)enoxaparin 40 mg QD on the event rate on the composite of adjudicated proximal DVT, non-fatal PE and VTE-related death (see Section 6.4.2) through Day 12 of double-blind treatment.

No


1) Subjects must be willing and able to give written informed consent. Consent toparticipate in the study must be obtained prior to any screening procedures.2) Subjects undergoing elective unilateral or bilateral same day total knee replacement or a revision of at least one component of a total knee replacement.3) Subject must be willing and able to undergo bilateral ascending contrastvenography. 4) Men and women, of any race, at least 18 (or legal age of consent if greater) years of age5) Women of childbearing potential (WOCBP) must be using an adequate method ofcontraception. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 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 treatment period of the study2) Women who are pregnant or breastfeeding3) Women with a positive pregnancy test on enrollment or prior to investigationalproduct administration4) Known or suspected or acquired bleeding or coagulation disorder in the subject or a first degree relative5) Known or suspected history of heparin-induced thrombocytopenia6) Known coagulopathy7) Active bleeding or at high risk for bleeding8) Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days9) Active hepatobiliary disease10) Alcohol and/or substance abuse within the past year11) Any condition, in the opinion of the Investigator, for which surgery oradministration of an anticoagulant is contraindicated12) Two consecutive blood pressure readings within 15-30 minutes with supineSBP > 180 mm Hg or supine DBP > 105 mm Hg13) Hemoglobin < 10 g/dL14) Platelet count < 100,000/mm315) Creatinine clearance < 30 mL/min as estimated by the method of Cockcroft andGault (see Section 6.3.4)16) ALT or AST > 2 x ULN or a Total Bilirubin ? 1.5 x ULN (unless an alternativecausative factor [eg, Gilbert’s syndrome] is identified)17) Hypersensitivity to unfractionated heparin (UFH), low molecular weight heparin(LMWH), porcine products, or iodinated contrast medium (for venogram)18) Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)19) Current use of dextrans or fibrinolytics20) Treatment with medications affecting coagulation or platelet function unless theycan be withdrawn21) Planned indwelling intrathecal or epidural catheter that can not be removed at least 5 hours prior to first dose of post-operative study drug.

The primary endpoint is the composite of adjudicated asymptomatic and symptomaticDVT, non-fatal PE and all-cause death through Day 12 of double-blind treatment insubjects undergoing elective unilateral or same day bilateral knee replacement surgery.The secondary endpoint is the composite of adjudicated asymptomatic and symptomatic proximal DVT, non-fatal PE and all VTE related death through Day 12 of double-blind treatment in subjects undergoing elective total knee replacement surgery.

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:

2
0
  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:


144

Para estudios internacionales:


1284
3670

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha