INFORMACIÓN DE FÁRMACOS USADOS:
FÁRMACO 1:
Función del fármaco :
Test
Nombre comercial :
innohep
Nombre laboratorio farmacéutico:
LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A
Nombre del producto-fármaco(s):
innohep
Código del producto-fármaco:
Forma farmacéutica:
Injection*
Vía de administración:
Subcutaneous use
Detalles del Fármaco (Principio Activo):
Código promotor:
Otra información sobre tipo de fármaco:
Concentración del fármaco:
Unidades :
IU/ml internati
Tipo:
equal
Dosis:
20000
Contenido del fármaco
Principio Activo de origen químico:
No
Principio Activo de origen biológico / biotecnológico (otro de Terapia Avanzada):
Si
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:
Information no disponible en EudraCT
Producto extractivo:
Information no disponible en EudraCT
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 :
Comparator
Nombre comercial :
Heparin LEO
Nombre laboratorio farmacéutico:
LEO Pharma A/S (LEO Pharmaceutical Products Ltd. A
Nombre del producto-fármaco(s):
Heparin
Código del producto-fármaco:
Forma farmacéutica:
Injection*
Vía de administración:
Subcutaneous useIntravenous bolus use (Noncurrent)
Detalles del Fármaco (Principio Activo):
Código promotor:
Otra información sobre tipo de fármaco:
Concentración del fármaco:
Unidades :
IU/ml internati
Tipo:
equal
Dosis:
25000
Contenido del fármaco
Principio Activo de origen químico:
No
Principio Activo de origen biológico / biotecnológico (otro de Terapia Avanzada):
Si
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:
Information no disponible en EudraCT
Producto extractivo:
Information no disponible en EudraCT
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:
No hay placebos asignados al ensayo
Indicaciones:
Enfermedad de investigación:
Enfermedad Trombótica
Treatment of acute deep vein thrombosis in elderly patients with impaired renal function
Objetivo principal del ensayo:
The primary objective of this study is to compare the safety of innohep and unfractionated heparin (UFH) in terms of Clinically Relevant Bleedings in elderly patients with impaired renal function for initial treatment of acute deep vein thrombosis (DVT).
Objetivos secundarios del ensayo:
A secondary objective of this study is to verify that innohep in elderly patients with impaired renal function is effective in terms of prevention of recurrences of venous thromboembolism (VTE).Other secondary and tertiary objectives are to evaluate other safety endpoints under parallel treatment with innohep or unfractionated heparin (UFH) and oral anticoagulants (OAC) and to evaluate interactions between various baseline parameters in relation to secondary and tertiary response criteria.
El ensayo contiene un sub-estudio:
Information no disponible en EudraCT
Título completo, fecha y versión de cada sub-estudio y la relación de sus objetivos:
Criterios de Inclusión:
1. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out2. Patients with a symptomatic DVT (distal or proximal) with or without PE objectively confirmed by a positive ultrasonography or venography (performed within 48 hours prior to randomisation)3. Patients with an indication for DVT treatment with SC LMWH or UFH followed by OAC for at least 90 Days 4. Hospitalised patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in hospital or in an out-patient setting5. Patients with a creatinine clearance ? 60 mL/min calculated according to the Cockcroft-Gault formula6. Age equal to or more than 75 years7. Male or female8. Any ethnic origin
Criterios de exclusión:
1. Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation2. Patients on oral anticoagulant treatment at or within last 1 week prior to randomisation3. Patients with a symptomatic VTE requiring thrombolytic therapy or invasive intervention4. End Stage Renal Disease patients requiring dialysis5. Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period6. Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period7. Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)8. Patients with a platelet count < 100.000.000.000/L9. Patients with a known history of heparin-induced thrombocytopenia10. Patients with known severe hepatic insufficiency manifested in a INR ? 1,511. Patients with an uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg at at least 2 measurements within 24 hours prior to randomisation12. Patients with ischaemic stroke at or within the last 1 week prior to randomisation 13. Patients with a known haemorrhagic stroke within 3 months prior to randomisation14. Patients with a known bacterial endocarditis within 3 months prior to randomisation15. Known or suspected hypersensitivity to component(s) of Investigational Products.16. Current participation in any other interventional clinical trial17. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 1 month18. Patients previously randomised in this trial19. Patients known or suspected of not being able to comply with the trial protocol (e.g. cognitive impairment, alcoholism, drug dependency or psychotic state).
Criterios de valoración:
Clinically Relevant Bleedings prior to day 90 +/-5.
Fases:
Fase IV
