Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio aleatorizado en fase III, doble ciego, en grupos paralelos, de la eficacia y la seguridad de etexilato de dabigatrán (150 mg bid) por vía oral, en comparación con warfarina (INR 2,0-3,0) para el tratamiento durante 6 meses del tromboembolismo venoso sintomático agudo, después del tratamiento inicial (5-10 días) con un anticoagulante parenteral aprobado para esta indicación. RE-COVER

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Resumen

2017-03-15 03:57:20
2005-001999-12
1160.53
Estudio aleatorizado en fase III, doble ciego, en grupos paralelos, de la eficacia y la seguridad de etexilato de dabigatrán (150 mg bid) por vía oral, en comparación con warfarina (INR 2,0-3,0) para el tratamiento durante 6 meses del tromboembolismo venoso sintomático agudo, después del tratamiento inicial (5-10 días) con un anticoagulante parenteral aprobado para esta indicación. RE-COVER
RE-COVER
1160.53

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Boehringer Ingelheim España, S.A. Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Warfarin tablets BP 1mg
Norton Pharmaceuticals Limited dabigatrane etexilate
BIBR 1048 MS Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

BIBR 1048 MS

Concentración del fármaco:

mg milligram(s) equal

150

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Comparator Warfarin tablets BP 3mg
Norton Pharmaceuticals Limited Warfarin tablets BP 1mg
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

1

Contenido del fármaco


Si
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
  FÁRMACO 3:
Comparator Warfarin tablets BP 5 mg
Norton Pharmaceuticals Limited Warfarin tablets BP 3 mg
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

3

Contenido del fármaco


Si
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
  FÁRMACO 4:
Comparator
Warfarin tablets BP 5 mg
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

5

Contenido del fármaco


Si
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Capsule, hard

Oral use
  PLACEBO 2:

Si
Tablet

Oral use

Información General



Enfermedad Trombótica

Acute symptomatic venous thromboembolism (VTE), i.e. uni- or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) confirmed by definitive objective clinical test


To determine the comparative efficacy of dabigatran etexilate (150 mg bid), compared to warfarin (INR of 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism (VTE).

To determine the comparative safety of dabigatran etexilate (150 mg bid), compared to warfarin (INR of 2.0-3.0) for 6 month treatment of acute symptomatic venous thromboembolism (VTE).

Information no disponible en EudraCT


1. Acute symptomatic uni- or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) confirmed by definitive objective clinical test in patients for whom at least 6 months of anticoagulant therapy is considered appropriate by the investigator2. Male or female, being 18 years of age or older3. Written informed consent for study participation

1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment2. PE satisfying at least one of the following criteria:? Haemodynamic instability? Embolectomy is indicated or performed? Thrombolytic therapy is indicated or performed? Suspected source of PE is other than the legs3. Actual or anticipated use of vena cava filter4. Contraindications to anticoagulant therapy including contraindications to heparins or other alternate approved therapy used for initial treatment, and warfarin5. Patients who in the investigator’s opinion should not be treated with warfarin6. Allergy to heparins (including history of heparin induced thrombocytopenia) or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications7. Patients who in the investigator’s judgement are perceived as having an excessive risk of bleeding, for example because of:? Hemorrhagic disorder or bleeding diathesis? Trauma or major surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned major surgery? Any of the following intracranial pathologies: neoplasm, arteriovenous malformation or aneurysm? History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra articular bleeding? Gastrointestinal haemorrhage within the past 3 months? Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days? Treatment with thrombolytic agents within 14 days before enrolment? Anticipated need of restricted medication during the treatment period(see CTP Section 4.2.2)? Known thrombocytopenia (platelet count < 100•109•L-1)8. Known anaemia (haemoglobin < 100 g•L-1)9. Need of anticoagulant treatment for disorders other than VTE10. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrolment (investigator’s judgement), acute bacterial endocarditis or history of myocardial infarction within the last 3 months11. Elevated AST or ALT > 2x ULN based on the local lab results obtained at screening and prior to randomisation (or central screening lab if available on time)12. Liver disease expected to have any potential impact on survival (e.g. acute hepatitis, possibly active hepatitis B, hepatitis C or cirrhosis, but not Gilbert’s syndrome or hepatitis A with complete recovery)13. Patients who have developed transaminase elevations upon exposure to ximelagatran14. Severe renal impairment (estimated creatinine clearance ? 30 ml/min)15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (NOTE: A negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study)16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study17. Patients considered unsuitable for inclusion by the investigator, e.g. because considered unreliable to comply with the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)18. In case of anticipated study related diagnostic procedures requiring contrast medium (e.g. contrast venography or pulmonary angiography):? Elevated serum creatinine, which in the investigator’s opinion contraindicates these examinations? Known allergy to radio opaque contrast media or iodine, which in the investigator’s opinion contraindicates these examinations

Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE within 6 months. (VTE is defined as the composite incidence of DVT and PE.)

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

2
7
  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:


80

Para estudios internacionales:


1275
2550

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha