Hemotrial Un proyecto de SEHH

Ensayo clínico

Ensayo clínico controlado, doble ciego y aleatorizado de BAY 59-7939 en la prevención del tromboembolismo venoso en pacientes con cirugía electiva de sustitución total de cadera. Estudio RECORD 1RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement

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Resumen

2017-03-15 03:57:56
2005-004351-35
BAY 59-7939/11354
Ensayo clínico controlado, doble ciego y aleatorizado de BAY 59-7939 en la prevención del tromboembolismo venoso en pacientes con cirugía electiva de sustitución total de cadera. Estudio RECORD 1RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement
RECORD 1
BAY 59-7939/11354

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Bayer HealthCare AG Germany

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Clexane 40 mg Aventis Pharma Spin
Aventis Pharma Spain Enoxaparin
BAY 59-7939 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

BAY 59-7939 5-Chloro-N-({(5

Concentración del fármaco:

mg milligram(s) equal

10

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
Solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

40

Contenido del fármaco


No
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

Si
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Film-coated tablet

Oral use
  PLACEBO 2:

Si
Solution for injection

Subcutaneous use

Información General



Enfermedad Trombótica

Prevención del tromboembolismo venosoPrevention of venous thromboembolism


The objective of this trial is to assess the efficacy and safety of BAY 59-7939 10 mg once daily dosing in extended prevention of VTE in men and women aged 18 years or above undergoing elective total hip replacement.


Information no disponible en EudraCT


Male and female patients aged 18 years or above.Patients scheduled for elective total hip replacement.Patients’ written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures.

1. Planned, staged total bilateral hip replacement.2. Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin.3. Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin.4. Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media).5. Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. (Note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible both partners should use adequate barrier birth control).6. Drug- or alcohol abuse.7. Concomitant use of HIV-protease inhibitors.8. Therapy with another investigational product within 30 days prior start of study.9. Planned intermittent pneumatic compression during active treatment period.10. Concomitant participation in another trial or study.11. Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator (see section 4.5.7 of the study protocol)12. For other concomitant medication not allowed see section 4.5.7 of the study protocol

The primary efficacy endpoint is defined as a composite endpoint of:• Any DVT (proximal and/or distal) and• Non fatal PE and• Death from all causes.The analysis of the primary efficacy endpoint will be solely based on the assessments made by the Venography and the VTE Adjudication Committees.Secondary efficacy endpoints are:•Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE-related death (referred to as ‘major VTE’)•Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death (composite of any DVT and nonfatal PE and VTE-related death)•Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE related death (composite of proximal DVT and nonfatal PE and death from all causes )•Incidence of symptomatic VTE (DVT, PE)•Incidence of DVT (total, proximal, distal)•Incidence of symptomatic VTE during follow-up (i.e. after the end of the time window for primary efficacy assessment).The analysis of the secondary efficacy endpoints related to VTE will be solely based on the assessments made by the Venography and VTE Adjudication committees.A further study endpoint is health care resource utilization, assessed by duration of hospitalization, any re-hospitalization during the entire study period, and rehabilitation center stay following hospital discharge.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

1
0
  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:


350

Para estudios internacionales:


3500
4200

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha