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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-001446-14
    Sponsor's Protocol Code Number:N/GF-TORAFIC-06
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2006-001446-14
    A.3Full title of the trial
    Multicenter parallel-group, concealed and randomized allocation and blinded-endpoint study, to evaluate the effects of Torasemide PR versus furosemide on a biochemical marker of collagen synthesis and deposition, in hypertensive patients with heart failure
    Ensayo clínico multicéntrico, paralelo, con asignación oculta y aleatorizada, y evaluación enmascarada, para estudiar los efectos sobre un marcador sérico de síntesis y depósito miocárdico de fibras de colágeno, de torasemida LP versus furosemida en pacientes con insuficiencia cardíaca crónica de origen hipertensivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter parallel-group, concealed and randomized allocation and blinded-endpoint study, to evaluate the effects of Torasemide PR versus furosemide on a biochemical marker of collagen synthesis and deposition, in hypertensive patients with heart failure
    Ensayo clínico multicéntrico, paralelo, con asignación oculta y aleatorizada, y evaluación enmascarada, para estudiar los efectos sobre un marcador sérico de síntesis y depósito miocárdico de fibras de colágeno, de torasemida LP versus furosemida en pacientes con insuficiencia cardíaca crónica de origen hipertensivo
    A.3.2Name or abbreviated title of the trial where available
    TORAFIC
    TORAFIC
    A.4.1Sponsor's protocol code numberN/GF-TORAFIC-06
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNOVAG S.A., FERRER GRUPO
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNOVAG S.A., FERRER GRUPO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVAG S.A., FERRER GRUPO
    B.5.2Functional name of contact pointMedical Advisor, Dpto. Médico
    B.5.3 Address:
    B.5.3.1Street AddressGRAN VÍA CARLOS III, 94
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number3493600 37 28
    B.5.5Fax number3493490 70 78
    B.5.6E-mailefernandez@ferrergrupo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SUTRILNEO
    D.2.1.1.2Name of the Marketing Authorisation holderNOVAG, S.A. FERRER GRUPO
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTorasemida
    D.3.9.1CAS number 56211-04-6
    D.3.9.2Current sponsor codeAC4464
    D.3.9.3Other descriptive nameBM02015,JDL464,N-(((metiletil) amino)carbonil)-4-((3-metilfenil)-amino)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SEGURIL
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSEGURIL
    D.3.2Product code NO PROCEDE
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFurosemida
    D.3.9.1CAS number C03CA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heart failure
    Insuficiencia cardíaca
    E.1.1.1Medical condition in easily understood language
    Heart failure
    Insuficiencia cardíaca
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10007582
    E.1.2Term Cardiac insufficiency
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar la superioridad de Torasemida-LP respecto Furosemida en la reducción de la fibrosis miocárdica en pacientes con insuficiencia cardíaca, en grados II, III y IV, según clasificación de la New York Heart Association (NYHA).
    E.2.2Secondary objectives of the trial
    - Valorar eficacia de Torasemida LP versus furosemida en pacientes con insuficiencia cardíaca mediante la medida de los cambios en los signos y síntomas de la patología en estudio.
    - Valorar incidencia de eventos cardiovasculares durante el seguimiento del tratamiento en estudio.
    - Valorar incidencia de ingresos hospitalarios y/o atenciones en urgencias (estancias <24 horas) y/o atenciones domiciliarias por causa cardiovascular vinculada a la patología en estudio durante el seguimiento.
    - Valorar seguridad y tolerabilidad de Torasemida LP versus furosemida en el tratamiento de la insuficiencia cardíaca.
    - Valorar los cambios en la Calidad de Vida (CV) mediante el Test de Minnesota en pacientes con insuficiencia cardiaca que estén recibiendo Torasemida LP versus furosemida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Edad superior a 18 años.
    2. Pacientes con insuficiencia cardiaca grado II, II y IV, según criterios de ESC-2005 (ver anexo VIII), con fracción de eyección del ventrículo izquierdo preservada (FE >40%) o deprimida.
    3. Pacientes con IC clínicamente estable (ver criterios en anexo IX), que precisen diuréticos para su tratamiento.
    4. Pacientes con hipertrofia ventricular izquierda diagnosticada por ecocardiograma (ver anexo VIII).
    5. Pacientes con diagnóstico establecido de hipertensión arterial (ver anexo VII).
    6. Pacientes sin cardiopatía isquémica o bien, con antecedentes de cardiopatía isquémica no reciente (infarto de miocardio previo hace más de 6 meses o síndrome coronario, accidente vascular cerebral o vasculopatía periférica acontecido hace más de 3 meses).
    7. Pacientes que cuyo estado psíquico, cognitivo y/o clínico no suponga un impedimento para comprender la naturaleza del estudio ni para completar el seguimiento.
    8. Pacientes que otorguen su consentimiento por escrito para participar en el estudio
    E.4Principal exclusion criteria
    1. Pacientes con diagnóstico de IC cuya etiología sea estenosis aórtica o miocardiopatía hipertrófica.
    2. Pacientes con antecedentes recientes de síndrome coronario, accidente vascular cerebral o de vasculopatía periférica, (acontecidos durante los últimos 3 meses).
    3. Pacientes con antecedentes recientes de infarto agudo de miocardio (que se produjo en los últimos 6 meses).
    4. Pacientes con angina de pecho inestable.
    5. Pacientes con arritmia cardiaca severa (taquicardia ventricular mantenida, fibrilación auricular, flutter auricular, bradicardia por debajo de 45 latidos por minuto).
    6. Mujeres embarazadas o en periodo de lactancia y mujeres en edad fértil que no estén utilizando un método anticonceptivo seguro o que no tengan intención de utilizarlo durante el desarrollo del ensayo. Se considera un método anticonceptivo seguro, los tratamientos anticonceptivos orales o parenterales, o los métodos de barrera: preservativo masculinos o femeninos, diafragma y/o DIU.
    7. Pacientes en tratamiento con fármacos antialdosterónicos, en los 6 meses previos al inicio del ensayo.
    8. Pacientes con antecedentes de hipersensibilidad conocida al compuesto en estudio o a las sulfonilureas
    9. Pacientes con insuficiencia hepática definida por los siguientes parámetros analíticos: SGPT (ALT) o SGOT (AST) más de dos veces por encima del límite superior de la normalidad.
    10. Pacientes con insuficiencia renal crónica definida por los siguientes parámetros analíticos:
    Creatinina sérica superior a 2,5 mg/dl
    Filtrado glomerular <30%
    11. Pacientes con diabetes mellitus insulino-dependiente no controlada
    12. Pacientes en los que se detecten contraindicaciones a partir de los datos obtenidos durante la selección en la exploración física, hematología, bioquímica, análisis de orina y ECG de 12 derivaciones
    13. Participación simultánea en otro ensayo clínico o tratamiento con cualquier fármaco en fase de investigación dentro de los 30 días previos a la firma del consentimiento informado
    14. Pacientes con intolerancia a la lactosa.
    15. Pacientes con tratamiento concomitante con litio
    16. Pacientes que precisen tratamientos crónicos (tratamiento > a 7 días) con anti-inflamatorios no esteroideos, inclusive aspirina.
    17. Pacientes con tratamiento concomitante con antibióticos amino glucósidos, ácido etacrínico.
    18. Pacientes en tratamiento con antiarrítmicos del grupo 1a, 1b o 2.
    19. Historia de dependencia a drogas o alcohol dentro de los 6 meses previos al inicio del ensayo
    20. Cualquier circunstancia o condición clínica que, en opinión del investigador, no permitiría completar con seguridad el protocolo y la administración de Torasemida LP o Furosemida.
    21. Pacientes que se encuentren controlados a dosis superiores de torasemida 10mg/día o furosemida 40mg/día o que hayan precisado dosis más altas a las mencionadas para mantener la estabilidad de la insuficiencia cardíaca en el mes anterior al inicio del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Concentraciones séricas del péptido carboxiterminal del procolágeno tipo I (PIP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 meses
    E.5.2Secondary end point(s)
    - Valorar eficacia de Torasemida LP versus furosemida en pacientes con insuficiencia cardíaca mediante la medida de los cambios en los signos y síntomas de la patología en estudio.
    - Valorar incidencia de eventos cardiovasculares durante el seguimiento del tratamiento en estudio.
    - Valorar incidencia de ingresos hospitalarios y/o atenciones en urgencias (estancias <24 horas) y/o atenciones domiciliarias por causa cardiovascular vinculada a la patología en estudio durante el seguimiento.
    - Valorar seguridad y tolerabilidad de Torasemida LP versus furosemida en el tratamiento de la insuficiencia cardíaca.
    - Valorar los cambios en la Calidad de Vida (CV) mediante el Test de Minnesota en pacientes con insuficiencia cardiaca que estén recibiendo Torasemida LP versus Furosemida
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned19
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 142
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state142
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    no aplica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
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