Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio multicéntrico en fase III, aleatorizado, doble ciego, de grupos paralelos y control activo, para evaluar la eficacia y la seguridad de dabigatran etexilato oral (150 mg bid) en comparación con warfarina (INR 2.0-3.0) para la prevención secundaria del tromboembolismo venoso. RE-MEDY.

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Estudio multicéntrico en fase III, aleatorizado, doble ciego, de grupos paralelos y control activo, para evaluar la eficacia y la seguridad de dabigatran etexilato oral (150 mg bid) en comparación con warfarina (INR 2.0-3.0) para la prevención secundaria del tromboembolismo venoso. RE-MEDY.


Resumen

2017-03-15 03:57:33
2005-002536-94
1160.47
Estudio multicéntrico en fase III, aleatorizado, doble ciego, de grupos paralelos y control activo, para evaluar la eficacia y la seguridad de dabigatran etexilato oral (150 mg bid) en comparación con warfarina (INR 2.0-3.0) para la prevención secundaria del tromboembolismo venoso. RE-MEDY.
RE-MEDY
1160.47

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 dabigatran 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

Confirmed Venous Thromboembolism (VTE) i.e. uni or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins and/or pulmonay embolism (PE) - treated with anticoagulant for 3 to 6 months


To determine the comparative efficacy of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to six months for confirmed acute symptomatic venous thromboembolism.

To determine the comparative safety of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment of venous thrombolembolism.

Information no disponible en EudraCT


1. Objectively confirmed symptomatic uni- or bilateral DVT of the leg involving proximal veins or PE, treated with approved anticoagulant therapy, or with study drug taken during participation in trial 1160.53, for 3 to 6 months at the time of screening, in patients considered at increased risk of recurrent VTE [proximal veins are: trifurcation area, popliteal, superficial femoral, deep femoral, common femoral and iliac vein]2. Male or female, being 18 years of age or older3. Written informed consent for study participation

1. Symptomatic DVT or PE at screening2. Patients with primary PE with suspected origin other that leg limbs (e.g. upper limbs, right heart).3. Actual or anticipated use of vena cava filter4. Interruption of anticoagulant therapy for 2 or more weeks during the 3-6 months of treatment for the prior VTE.5. Patients who in the investigator’s opinion should not be treated with warfarin6. Allergy to 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 bleeding8. 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, or 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, except for the RE-COVER trial, 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 examinationsKnown 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 during the treatment period. 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:

3
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:


64

Para estudios internacionales:


970
2000

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado