Hemotrial Un proyecto de SEHH

Ensayo clínico

A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with half dose (i.e. 75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

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Resumen

2017-03-15 03:55:46
2004-001988-21
1160.48
A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with half dose (i.e. 75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.
RE-NOVATE (Extended thromboembolism prevention after hip surgery)
1160.48

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 Clexane 40 mg
Aventis Pharma dabigatran etexilate
BIBR 1048 MS Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

75

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

Information no disponible en EudraCT
  FÁRMACO 2:
Test
dabigatran etexilate
BIBR 1048 MS Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

110

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

Information no disponible en EudraCT
  FÁRMACO 3:
Comparator
Solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

40

Contenido del fármaco


Information no disponible en EudraCT
Si

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

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

Si
Capsule, hard

Oral use
  PLACEBO 2:

Si
Solution for injection

Subcutaneous use

Información General



Enfermedad Trombótica

Prevention of venous thromboembolism following primary elective total hip replacement surgery


To determine the comparative efficacy of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

To determine the comparative safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Information no disponible en EudraCT


1. Patients scheduled to undergo a primary, unilateral elective total hip replacement 2. Male or female being 18 years or older 3. Patients weighing at least 40 kg4. Written informed consent for study participation

1. History of bleeding diathesis2. Constitutional or acquired coagulation disorders that in the investigator’s judgement puts the patient at excessive risk for bleeding3. Major surgery or trauma (e.g. hip fracture) within the last 3 months4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrolment (investigator’s judgement) or history of myocardial infarction within the last 3 months5. Spinal or epidural anaesthesia, for which more than 3 attempts at placement were made (sticks), or the placement was traumatic6. Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm 7. History of VTE still requiring specific treatment8. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months9. Gastric or duodenal ulcer within the last year10. Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert’s syndrome or hepatitis A with complete recovery)11. Elevated AST or ALT > 2x upper limit of normal, based on central lab results or local lab results within 1 month before enrolment12. Known severe renal insufficiency (CrCl < 30 ml/min)13. Elevated creatinine, which in the investigator’s opinion contraindicates venography14. Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin > 160 mg/day or NSAID with t½ > 12 hours within 7 days prior to hip replacement surgery or anticipated need during the study treatment period (COX-2 selective inihibitors are allowed)15. Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb16. Pre-menopausal women (last menstruation ?1 year prior to signing informed consent) who: are pregnant, nursing or are of child-bearing potential and are NOT practising acceptable methods of birth control, or do NOT plan to continue practising an acceptable method throughout the study 17. Known allergy to radio opaque contrast media18. History of thrombocytopenia (incl. heparin induced thrombocytopenia) or a platelet count < 100,000 cells/microliter at visit 119. Allergy to heparins or dabigatran20. Active malignant disease or current cytostatic treatment21. Participation in a clinical trial during the last 30 days22. Leg amputee23. Known alcohol or drug abuse which would interfere with completion of the study24. Contraindications to enoxaparin25. Previous participation in this study or RE-MODEL or RE-MOBILIZE

Composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period.Total VTE includes deep vein thrombosis [DVT] (proximal and distal) as detected by routine venography performed within 24 hours of the last dose of oral study medication; symptomatic DVT, confirmed by venous duplex ultrasound, venography or by autopsy; and pulmonary embolism confirmed by pulmonary ventilation-perfusion (V-Q) scintigraphy and chest X-ray or pulmonary angiography or spiral CT.

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:

1
3
  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:


192

Para estudios internacionales:



3330

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha