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    Summary
    EudraCT Number:2009-016498-13
    Sponsor's Protocol Code Number:TIC-0911
    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:2010-07-02
    Trial 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 number2009-016498-13
    A.3Full title of the trial
    Estudio aleatorizado y doble-ciego para valorar el beneficio del tratamiento con testosterona en pacientes deficientes con IC avanzada (TIC)
    A.4.1Sponsor's protocol code numberTIC-0911
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación para la Formación en Investigación Sanitarias de la Región de Murcia
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 REANDRON 1000 mg/4 ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HISPANIA, S.L.
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONA UNDECANOATO
    D.3.9.3Other descriptive nameTESTOSTERONA UNDECANOATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Deficiencia de testorena en varones con insuficiencia cardiaca.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10007554
    E.1.2Term Cardiac failure
    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
    Estudiar si la administración de testosterona se asocia a una mejoría de la evolución clínica, en términos de menor necesidad de reingresos hospitalarios por IC, menor número de descompensaciones que requieran medicación intravenosa y menor mortalidad por cualquier causa.
    E.2.2Secondary objectives of the trial
    - Estudiar si la administración de testosterona se asocia a una mejoría del estatus clínico (score acumulado de Framinghan)
    - Estudiar si la administración de testosterona se asocia a una mejoría de los parámetros de función cardiaca. Se estudiaran los cambios en la concentración plasmática de NT-proBNP y los cambios en la función cardiaca sistólica y remodelado geométrico ventricular y auricular, izquierdo y derecho, por ecocardiografía.
    - Estudiar si la administración de testosterona se asocia a una mejoría de la capacidad funcional, manifestada en una reducción de la clase funcional NYHA y un aumento de la distancia recorrida en el test de los seis minutos.
    - Estudiar si la administración intermitente de testosterona en esta población es bien tolerada, sin eventos clínicos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Al menos un ingreso hospitalario por IC.
    2. Situación clínica ambulatoria y estable, en clase funcional NYHA II-IV.
    3. Fracción de eyección ventricular izquierda menor del 40%, medida en los últimos 3 meses.
    4. Concentración de NT-proBNP mayor de 1000 pg/ml.
    5. Déficit objetivo de testosterona total y de testosterona libre según la ecuación validada de Vermulen, medida en el último mes.
    6. Edad mayor de 18 años.
    7. Pacientes que hayan otorgado su consentimiento informado por escrito.
    E.4Principal exclusion criteria
    _ Ausencia de consentimiento informado
    _Toma de anticoagulantes orales
    _Enfermedad valvular severa con indicación de reparación quirúrgica.
    _Enfermedad extracardiaca con pronóstico vital estimado menor de 1 año.
    _Antecedente de carcinoma prostático dependiente de andrógenos, hiperplasia benigna de próstata en tratamiento o antígeno prostático específico > 3 ng/ml.
    _Antecedente de carcinoma de glándula mamaria o tumor hepático
    _Insuficiencia renal grave (tasa de filtrado glomerular <30 ml/kg/min)
    _Síndrome coronario agudo en el último año
    _Insuficiencia renal o hepática graves
    _Hipertensión arterial no controlada
    _Eritrocitosis (hematocrito mayor del 50%)
    _Hipersensibilidad conocida al principio activo o cualquiera de los excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    -La variable primaria de resultado del ensayo es la combinada de muerte por cualquier causa, ingreso hospitalario por IC o descompensación de IC que requiera fármacos intravenosos para su estabilización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months, 1 year
    E.5.2Secondary end point(s)
    _Mortalidad de causa cardiovascular, por IC y por otras causas.
    _Reingreso hospitalario por cualquier causa.
    _Número de descompensacones de IC que hayan requerido medicación intravenosa para su estabilización.
    _Mejoría de los síntomas: cambios en capacidad funcional (NYHA, distancia recorrida en el test de los 6 minutos), cambios en test de calidad de vida (Minnessota Living Heart Failure) y en el score clínico modificado de Framingham.
    _Cambios en la función cardiaca evaluada por parámetros ecocardiográficos y concentración de NT-proBNP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    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 No
    E.6.5Efficacy No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state126
    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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
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