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    Summary
    EudraCT Number:2007-003059-36
    Sponsor's Protocol Code Number:Bay 58-2667/12480
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-02-13
    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 number2007-003059-36
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico y multinacional de fase IIb para evaluar la eficacia y la tolerabilidad de BAY 58 2667 administrado por vía intravenosa en pacientes con insuficiencia cardiaca congestiva crónica descompensada
    A.4.1Sponsor's protocol code numberBay 58-2667/12480
    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 SponsorBayer Healthcare AG
    B.1.3.4CountryGermany
    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 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 No
    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 nameBAY 58-2667
    D.3.2Product code BAY 58-2667
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcinaciguat
    D.3.9.1CAS number 329773-35-5
    D.3.9.2Current sponsor codeBAY 58-2667
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.005
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pacientes con una insuficienca cardiaca congestiva crónica descompensada
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064653
    E.1.2Term Acute decompensated heart failure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El principal objetivo del estudio es investigar la seguridad y la eficacia de una fase de ajuste de la dosis (8 horas) y de una fase de mantenimiento (40 horas máximo) de BAY 58-2667 en sujetos con insuficiencia cardíaca congestiva crónica descompensada que necesitan farmacoterapia parenteral y monitorización hemodinámica invasiva (es decir, catéter de Swan Ganz permanente en la arteria pulmonar) y cuya PCWP (presión de enclavamiento pulmonar) es ≥ 18mmHg.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Deben cumplirse los siguientes criterios de inclusión:
    • Sujetos con insuficiencia cardíaca congestiva crónica y descompensada, clase III-IV de la NYHA, tanto isquémica como no isquémica, que necesiten hospitalización, y con indicación clínica de farmacoterapia parenteral y monitorización hemodinámica invasiva (es decir, catéter de Swan Ganz permanente en la arteria pulmonar) y PCWP ≥ 18 mmHg.
    • Los sujetos deben presentar diagnóstico clínico de ICC desde al menos 3 meses antes de su inclusión en el estudio.
    • Los sujetos (hombres y mujeres), deben tener 18 años o más de edad.
    • Los sujetos deben experimentar un empeoramiento en al menos uno de los síntomas que aparecen a continuación, que provoque su hospitalización en el momento de su inclusión en el estudio:
    • Síntomas de disnea como:
    Disnea (dificultad o fatiga respiratoria) en reposo,
    Disnea (dificultad o fatiga respiratoria) con un esfuerzo mínimo,
    Ortopnea (dificultades respiratorias excepto en posición erguida),
    Disnea nocturna (despertarse del sueño debido a molestias respiratorias).
    o
    • Signos clínicos de hipervolemia como:
    Edema periférico,
    Congestión hepática con ascitis,
    Congestión/crepitar pulmonar o derrame pleural (radiografía torácica),
    Distensión venosa yugular.
    • Fracción de eyección ventricular izquierda < 40% durante los últimos 6 meses.
    • Antecedentes de hospitalización por insuficiencia cardíaca o necesidad de tratamiento diurético IV durante los últimos 12 meses.
    • Capacidad para entender y disposición para firmar un consentimiento informado.
    E.4Principal exclusion criteria
    • Mujeres en edad fértil.
    • Insuficiencia cardíaca aguda recurrente.
    • Infarto agudo de miocardio y/o infarto de miocardio en los últimos 30 días.
    • Cardiopatía valvular con necesidad de intervención quirúrgica durante el transcurso del estudio.
    • Insuficiencia cardíaca debida a, o asociada con, una valvulopatía primaria no compensada, el funcionamiento deficiente de una válvula cardíaca artificial o a una cardiopatía congénita no compensada.
    • Miocardiopatía hipertrófica primaria.
    • Cardiopatía inflamatoria aguda, p.ej. miocarditis aguda.
    • Angina de pecho inestable que requiera angiografía.
    • Choque cardiogénico.
    • Sujetos que necesiten cualquiera de los siguientes fármacos: Nitratos, p.ej. nitroprusiato, nitroglicerina, nesitiride, levosimendán o cualquier tipo de fármaco inotrópico positivo durante las últimas 3 horas (se permite dobutamina hasta 4 µg/kg/minuto).
    • Necesidad de intubación endotraqueal y ventilación mecánica.
    • Sujetos con paro cardíaco o sujetos con antecedentes de paro cardíaco en los últimos 3 meses, a menos que fuera precipitado por un episodio del tipo de un infarto agudo de miocardio, inducido por la colocación de un catéter, por una anomalía electrolítica transitoria grave, un procedimiento electrofisiológico o por la colocación de un desfibrilador cardioversor implantable automático.
    • Sujetos con un riesgo elevado de paro cardíaco (p.ej. QTc > 450 mseg, bloqueo auriculoventricular II o III, etc.).
    • Fibrilación ventricular en los últimos 30 días (duración > 15 segundos).
    • Sujetos que muestren trastornos no controlados del ritmo ventricular durante la monitorización ECG.
    • Fibrilación o aleteo auricular no controlado o cualquier tipo de taquicardia supraventricular.
    • Cirugía cardíaca durante el último mes (como cirugía de revascularización coronaria, cirugía valvular, procedimiento de resincronización biventricular, cirugía de reducción ventricular o mioplasia cardíaca, implantación de un dispositivo mecánico de asistencia ventricular).
    • Presión arterial sistólica < 100 mmHg o > 180 mmHg.
    • Embolia pulmonar durante los 30 días previos a la inclusión en el estudio.
    • Administración de inhibidor PDE5 durante las 48 horas previas a la infusión del fármaco en estudio.
    • Inhibidores de CYP2C8 fuertes como el gemfibrozil (interrumpir al menos 24 horas antes de la infusión del fármaco en estudio).
    • Insuficiencia cardíaca secundaria a una enfermedad pulmonar con hipertensión arterial pulmonar primaria e hipertensión pulmonar tromboembólica crónica.
    • Antecedentes de signos clínicamente significativos de cualquier enfermedad grave distinta de una insuficiencia cardíaca que impida la participación.
    • Hepatopatía significativa (p.ej. hepatitis clínica aguda, hepatitis activa crónica, cirrosis).
    • Aclaramiento de creatinina calculado < 30ml/min. usando el algoritmo MDRD o la ecuación de Cockroft Gault.
    • BMI (índice de masa corporal) < 20 kg/m2 (se acepta BMI igual a 20).
    • Abuso de alcohol o drogas.
    • Participación simultánea en otro ensayo o estudio.
    • Tratamiento con otro producto en fase de investigación durante los 30 días anteriores al comienzo del estudio.
    • Cualquier otra afección o terapia, que, en opinión del investigador principal, hiciera que el sujeto no fuera adecuado para este estudio y que, presumiblemente, no permitiriera su participación durante todo el período planificado para el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El principal criterio de valoración de la eficacia será un cambio en la presión de enclavamiento capilar pulmonar (PCWP) desde el momento basal hasta 8 horas después, respecto al placebo.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 210
    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 Decision2008-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-03-26
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