INFORMACIÓN DE FÁRMACOS USADOS:
FÁRMACO 1:
Función del fármaco :
Test
Nombre comercial :
Nombre laboratorio farmacéutico:
Nombre del producto-fármaco(s):
Apixaban
Código del producto-fármaco:
BMS-562247-01
Forma farmacéutica:
Film-coated tablet
Vía de administración:
Oral use
Detalles del Fármaco (Principio Activo):
Código promotor:
BMS-562247-01
Otra información sobre tipo de fármaco:
Apixaban
Concentración del fármaco:
Unidades :
mg milligram(s)
Tipo:
equal
Dosis:
2.5
Contenido del fármaco
Principio Activo de origen químico:
Si
Principio Activo de origen biológico / biotecnológico (otro de Terapia Avanzada):
No
Producto de terapia génica:
No
Producto combinado que incluye un dispositivo, pero no implica una Terápia Avanzada:
Information no disponible en EudraCT
Producto radiofarmacéutico:
No
Producto inmunológico (como vacuna, alergeno, suero inmune):
No
Producto derivado del plasma:
No
Producto extractivo:
No
Producto recombinante:
Information no disponible en EudraCT
Producto que contiene organismo genéticamente modificado:
No
Producto contiene plantas medicinales:
No
Producto contiene medicina homeopática:
No
Otro tipo de medicamento:
No
FÁRMACO 2:
Función del fármaco :
Test
Nombre comercial :
Nombre laboratorio farmacéutico:
Nombre del producto-fármaco(s):
Apixaban
Código del producto-fármaco:
BMS-562247-01
Forma farmacéutica:
Film-coated tablet
Vía de administración:
Oral use
Detalles del Fármaco (Principio Activo):
Código promotor:
BMS-562247-01
Otra información sobre tipo de fármaco:
Apixaban
Concentración del fármaco:
Unidades :
mg milligram(s)
Tipo:
equal
Dosis:
5
Contenido del fármaco
Principio Activo de origen químico:
Si
Principio Activo de origen biológico / biotecnológico (otro de Terapia Avanzada):
No
Producto de terapia génica:
No
Producto combinado que incluye un dispositivo, pero no implica una Terápia Avanzada:
Information no disponible en EudraCT
Producto radiofarmacéutico:
No
Producto inmunológico (como vacuna, alergeno, suero inmune):
No
Producto derivado del plasma:
No
Producto extractivo:
No
Producto recombinante:
Information no disponible en EudraCT
Producto que contiene organismo genéticamente modificado:
No
Producto contiene plantas medicinales:
No
Producto contiene medicina homeopática:
No
Otro tipo de medicamento:
No
INFORMACIÓN DE PLACEBOS USADOS:
PLACEBO 1:
¿Se ha usado un placebo en el ensayo?:
Si
Formato del placebo:
Film-coated tablet
Modo de administración del placebo:
Oral use
PLACEBO 2:
¿Se ha usado un placebo en el ensayo?:
Si
Formato del placebo:
Film-coated tablet
Modo de administración del placebo:
Oral use
Indicaciones:
Enfermedad de investigación:
Enfermedad Trombótica
Venous Thromboembolism (VTE)Tromboembolismo venoso (TEV)
Objetivo principal del ensayo:
To determine if at least one of the apixaban dose regimens is superior to placebo in the combined endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death in subjects who have an objectively documented index event of symptomatic proximal DVT or symptomatic PE, have completed approximately 6 to 12 months of standard anticoagulant therapy for the treatment of the index event, and have no objectively documented symptomatic recurrence of VTE after the index event.
Objetivos secundarios del ensayo:
To characterize treatment effects of the two apixaban doses relative to placebo for the following:• adjudicated composite of recurrent symptomatic VTE or VTE-related death• adjudicated composite of recurrent symptomatic VTE or CV-related death• adjudicated symptomatic nonfatal DVT• adjudicated symptomatic nonfatal PE• adjudicated VTE-related death• adjudicated CV-related death• all-cause death• adjudicated major bleeding• the adjudicated composite of major bleeding and clinically relevant non-major bleedingTo characterize the primary efficacy outcome in the subset of subjects with index events of DVT only and in the subset of subjects with index events of PE with or without DVT.
El ensayo contiene un sub-estudio:
No
Título completo, fecha y versión de cada sub-estudio y la relación de sus objetivos:
Criterios de Inclusión:
1) Signed Written Informed Consent2) Target Populationa) Subjects who have:• an objectively documented index event of symptomatic proximal DVT or symptomatic PE; (1) Symptomatic proximal DVT is defined as symptomatic DVT with evidence of thrombosis in a deep vein proximal to (above) the popliteal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography. (2) Symptomatic PE with evidence of thrombosis demonstrated by imaging as follows:? an intraluminal filling defect in segmental or more proximal branches on spiral CT scan; or? an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or? a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)• completed approximately 6 to 12 months of standard anticoagulant therapy for the treatment of the index event; and• no objectively documented symptomatic recurrence of VTE after the index event.b) Subjects should be randomized within approximately 7 days of the last dose of their initial 6-to 12-month treatment or when their INR is 2 or less, if a VKA was used. Every attempt should be made to randomize subjects as soon as possible after discontinuation of their initial treatment.The index DVT and/or PE will be adjudicated by the ICAC according to the adjudication manual. Investigators are encouraged to assemble and to submit imaging dossiers to the ICAC as soon as possible during the period that extends from the beginning of the screening period up to 2 weeks after randomization. 3) Age and Sexa) Men and women, ages 18 years or greater.Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
Criterios de exclusión:
1) Sex and Reproductive Statusa) WOCBP who are unwilling or unable to use an acceptable method of birthcontrol to avoid pregnancy for the entire studyb) Women who are pregnant or breastfeedingc) Women with a positive pregnancy test on enrollment or prior to investigational product administration2) Medical History and Concurrent Diseasesa) Subjects whose index and past DVT(s) and/or PE(s) have all been due solely to a transient (reversible) risk factor (ie, provoked event, eg, secondary to surgery), and who are not expected to have, for 12 months or longer after randomization, persistence of a risk factor (e.g., wheelchair-bound) for DVT and/or PE recurrence.b) More than 12 months of anticoagulation planned for the most recent DVT or PE (index event).c) Subjects with the following indications for long-term treatment with a VKA, such as:• Mechanical valve• Atrial fibrillation or atrial flutter with moderate to high risk of systemic thromboembolism• Multiple episodes of unprovoked DVT or PE• Documented anti-phospholipid antibodies, anti-thrombin III deficiency, protein C deficiency, protein S deficiency, homozygous factor V Leiden, or homozygous prothrombin gene mutation.d) Subjects with cancer who will be treated indefinitely with anticoagulation therapy;e) Serious bleeding prior to randomization (see table under Protocol section 4.2.2 for exact timing of occurence resulting in subject exclusion from the study);f) Active and clinically significant liver disease (eg, hepatorenal syndrome);g) Life expectancy < 12 months;h) Bacterial endocarditis;i) Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg.3) Physical and Laboratory Test Findingsa) Platelet count <100,000/mm3 or hemoglobin <9 g/dLb) Serum creatinine >2.5 mg/dL [221 umol/L] or a calculated creatinine clearance <25 ml/min.c) ALT or AST >2 times upper limit of normal, or a total bilirubin >1.5 times upper limit of normal (unless the latter has an alternative causative factor identified [eg, Gilbert’s syndrome]).4) Prohibited Treatments and/or Therapiesa) Subjects requiring ASA >165 mg/day at randomization.b) Subjects requiring dual anti-platelet therapy (such as ASA plus clopidogrel or ASA plus ticlopidine) at randomization. Subjects who transition from dual anti-platelet therapy to monotherapy prior to randomization will be eligible for the trial.5) Other Exclusion Criteriaa) Prisoners or subjects who are involuntarily incarceratedb) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illnessc) Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of study treatment (with the exception of approved medications being used for an approved indication, eg, investigating a new dosing regimen for an approved indication);d) Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study; ore) Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or successful completion of, the study protocol
Criterios de valoración:
- The primary efficacy outcome is the incidence of an adjudicated composite of recurrent symptomatic VTE (nonfatal DVT and/or nonfatal PE) or all-cause death.- The primary safety outcome is the incidence of adjudicated major bleeding during the treatment period.
Fases:
Fase III
