Hemotrial Un proyecto de SEHH

Ensayo clínico

Controlled, Double-Blind, Randomized, Dose-ranging Study of once-daily regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement-ODIXaHIP-OD Study

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Controlled, Double-Blind, Randomized, Dose-ranging Study of once-daily regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement-ODIXaHIP-OD Study


Resumen

2017-03-15 03:55:32
2004-001341-14
BAY 59-7939 / 11527
Controlled, Double-Blind, Randomized, Dose-ranging Study of once-daily regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement-ODIXaHIP-OD Study
ODIXaHIP-OD
BAY 59-7939 / 11527

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 España N/A
BAY 59-7939 Tablet
Oral use

Detalles del Fármaco (Principio Activo):

2-Thiophenecarb

Concentración del fármaco:

mg milligram(s) equal

10
2-Thiophenecarb

Concentración del fármaco:

mg milligram(s) equal

20

Concentración del fármaco:

mg milligram(s) equal

30

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
Clexane
N/A Solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg/l milligram( 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
Tablet

Oral use
  PLACEBO 2:

Si
Solution for injection

Subcutaneous use

Información General



Enfermedad Trombótica

Deep Venous Thrombosis prophlaxis


The objective of this dose-ranging trial is to assess the efficacy and safety of BAY 59-7939 10 mg – 40 mg once daily dosing in prevention of VTE in men and in postmenopausal women aged 18 years or above undergoing elective primary total hip replacement. Population pharmacokinetics and pharmacodynamics (Factor Xa activity, PT, PT INR, aPTT and HepTest) will also be assessed.


Information no disponible en EudraCT


- Male patients aged 18 years or above and postmenopausal female patients.- Patients scheduled for elective primary total hip replacement (cemented or non-cemented prosthesis).- Patients’ written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures.Related to medical history- Any VTE prior to randomization.- Myocardial infarction (MI) or TIA or ischaemic stroke within the last 6 months prior to randomisation.- History of heparin-induced thrombocytopenia, allergy to heparins.- Intracerebral or intraocular bleeding within the last 6 months prior to randomisation.- History of gastrointestinal disease with gastrointestinal bleeding within the last 6 months prior to the study .- History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug (e.g. severe active inflammatory bowel disease, short gut syndrome).- Amputation of one leg.Related to current symptoms or findings- Heart insufficiency NYHA class III-IV.- Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits) including patients with acquired or congenital thrombopathy.- Thrombocytopenia (platelets < 100.000/µl).- Macroscopic haematuria.- Allergy to contrast media.- Severe hypertension (SBP > 200mmHg, DBP > 100 mmHg).- Impaired liver function (transaminases > 2 x ULN).- Impaired renal function (serum creatinine > 1.5 x ULN or creatinine clearance < 30 ml/min).- Active malignant disease - Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding.- Body weight < 45 kg.- Drug- or alcohol abuse.Related to current treatment- Patients who cannot stop therapy (in the opinion of the investigator/physician) with anticoagulants (eg phenprocoumon, warfarin-sodium, heparins and factor Xa inhibitors other than study medication) should be excluded from the study.- Fibrinolytic therapy.- Therapy with acetylic salicylic acid or other platelet aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrolment. Patients not able to stop ASA therapy will be excluded. - All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs) will be not allowed during the study treatment period.- Systemic and topical treatment with azole compounds (e.g. ketoconazol, fluconazol, itraconazol) and otherstrong CYP3A4-inhibitors eg HIV-protease inhibitors. Azole compounds and other strong CYP3A4-inhibitors eg HIV-protease should be stopped at least four days before enrolment.- Therapy with another investigational product within 30 days prior start of study.Miscellaneous- Planned intermittent pneumatic compression during active treatment period.- Planned epidural anaesthesia with indwelling epidural catheter (spinal or epidural anaesthesia without indwelling catheter are allowed).- If traumatic or repeated epidural and spinal puncture occur the patient should be excluded from study.- Concomitant participation in another trial or study.


The primary efficacy endpoint is a composite endpoint of:- Any DVT (proximal and/or distal) and- Non fatal PE and- Death from all causes.- The primary endpoint will be evaluated 6 - 10 days after surgery (or in case of symptoms indicating VTE). 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 DVTs (total, proximal, distal)- Incidence of symptomatic VTEs- Incidence of major VTE (ie. Proximal DVT, PE or VTE-related death)- The composite endpoint that results from the primary endpoint by substituting VTE related death for all death- Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug.- 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.Safety Variables- The main safety endpoint is the incidence of major bleeding observed after the first post-operative intake of study drug and not later than 2 days after last intake of study drug. Major bleeding observed before or after this period will be considered separately.- The analysis of the primary safety endpoint will solely be based on the classification made by the Bleeding Adjudication Committee.Other safety variables are:- Incidence of non-major bleeding (clinically significant and minor bleeding)- Treatment-emergent adverse events- Treatment-emergent serious adverse events- Deaths- Adverse events starting more than 7 days after stop of treatment- Incidence of (prolonged) hospitalisation- Transfusion requirements (heterologous and autologous transfusions).- Amount of blood loss (intraoperative blood loss)- Post-operative volume in drainage- Laboratory parameters.

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

Information no disponible en EudraCT
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Si

Centros participantes:


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

0
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:


40

Para estudios internacionales:


630
670

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha