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    Summary
    EudraCT Number:2019-003098-24
    Sponsor's Protocol Code Number:CLCZ696I12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-02
    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 number2019-003098-24
    A.3Full title of the trial
    A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)
    Estudio multicéntrico, aleatorizado, doble ciego (paciente e investigador) y controlado con placebo para estudiar la eficacia de sacubitrilo/valsartán por vía oral en pacientes adultos con miocardiopatía hipertrófica no obstructiva (MCH no obstructiva).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy of oral sacubitril/valsartan adult patients with non-obstructive hypertrophic cardiomyopathy
    Estudio de la eficacia de sacubitrilo/valsartán por vía oral en pacientes adultos con miocardiopatía hipertrófica no obstructiva.
    A.4.1Sponsor's protocol code numberCLCZ696I12201
    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 SponsorNovartis Farmacéutica, S.A.
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 90 0353036
    B.5.5Fax number-
    B.5.6E-maileecc.novartis@novartis.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 Entresto
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLCZ696 50 mg
    D.3.2Product code LCZ696
    D.3.4Pharmaceutical form Film-coated 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 INNsacubitril/valsartan
    D.3.9.3Other descriptive nameSACUBITRIL VALSARTAN
    D.3.9.4EV Substance CodeSUB171905
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Entresto
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLCZ696 100 mg
    D.3.2Product code LCZ696
    D.3.4Pharmaceutical form Film-coated 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 INNsacubitril/valsartan
    D.3.9.3Other descriptive nameSACUBITRIL VALSARTAN
    D.3.9.4EV Substance CodeSUB171905
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 3
    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 Entresto
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLCZ696 200 mg
    D.3.2Product code LCZ696
    D.3.4Pharmaceutical form Film-coated 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 INNsacubitril/valsartan
    D.3.9.3Other descriptive nameSACUBITRIL VALSARTAN
    D.3.9.4EV Substance CodeSUB171905
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-obstructive hypertrophic cardiomyopathy
    miocardiopatía hipertrófica no obstructiva
    E.1.1.1Medical condition in easily understood language
    non-obstructive hypertrophic cardiomyopathy, a genetic condition that affects the heart
    miocardiopatía hipertrófica no obstructiva, una afección genética que afecta el corazón.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020871
    E.1.2Term Hypertrophic cardiomyopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of LCZ696 on cardiopulmonary exercise test (CPET) parameters in patients with non-obstructive HCM
    Evaluar la eficacia de LCZ696 en los parámetros de la prueba de esfuerzo cardiopulmonar (PECP) en pacientes con MCH no obstructiva
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of LCZ696 in patients with non-obstructive HCM
    Evaluar la seguridad y tolerabilidad de LCZ696 en pacientes con MCH no obstructiva
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosed with Hypertrophic Cardiomyopathy with a left ventricular wall thickness greater than or equal to 13mm as determined by the echocardiogram obtained during the screening/baseline period
    • Left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by echocardiogram obtained during the screening/baseline period
    • Symptoms consistent with New York Heart Association (NYHA) Class II-III heart failure by physician assessment, or asymptomatic/NYHA Class I patients with:
    o NT-proBNP blood sample levels above 250 pg/ml and
    o peak VO2 of <80% of predicted based on age and gender as determined by cardiopulmonary exercise testing
    • Diagnóstico de miocardiopatía hipertrófica (ventrículo izquierdo hipertrofiado y no dilatado sin causa sistémica aparente) con un grosor de la pared ventricular izquierda de >/= 13 mm mediante el ecocardiograma obtenido durante el periodo de selección/basal
    • Fracción de Eyección del Ventriculo Izquierdo (FEVI) del >/=50 % en el ecocardiograma obtenido durante el periodo de selección/basal.
    • Síntomas compatibles con una insuficiencia cardíaca de clase II-III
    de la New York Heart Association (NYHA) en la evaluación del
    médico, o pacientes asintomáticos/clase I de la NYHA con:
    oNT-proBNP por encima de 250 pg/ml y
    o VO2 pico <80 % del valor teórico según la edad y el sexo.
    E.4Principal exclusion criteria
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for ≥7 days after stopping study drug
    • Patients with a resting or provokable left ventricular outflow tract gradient of greater than or equal to 30mm Hg
    • Septal reduction procedure within 3 months of the screening/baseline visit
    • History of atrial fibrillation or placement of ICD for secondary prevention
    • Patients with a peak VO2 on the screening/baseline cardiopulmonary exercise test of >80% of predicted based on age and gender
    • Patients who require treatment with ACE inhibitors, angiotensin receptor blockers (ARBs), or renin inhibitors
    • Known infiltrative or storage disorder such as Fabry disease, or amyloidosis
    • Known or suspected symptomatic coronary artery diseases or evidence of prior myocardial infarction
    • Systolic blood pressure of <100 mmHg or symptomatic hypotension during the screening/baseline period or treatment run-in period
    • Contraindication to ARB administration or prior history of angioedema
    • Persistent uncontrolled hypertension
    Other protocol-defined inclusion/exclusion criteria may apply
    • Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedar embarazadas, a menos que estén utilizando métodos anticonceptivos altamente efectivos durante la dosificación y durante >/=7 días después de suspender el fármaco del estudio.
    • Pacientes con un gradiente del tracto de salida del ventrículo izquierdo en reposo o provocable >30 mmHg
    • Procedimiento de reducción septal durante los 3 meses anteriores a la visita de selección/basal.
    • Antecedentes de fibrilación auricular o colocación de ICD para prevención secundaria.
    •Pacientes con un VO2 pico en la prueba de esfuerzo cardiopulmonar de la selección/basal >80 % del valor teórico según la edad y el sexo.
    • Pacientes que necesiten tratamiento con inhibidores de la ECA, antagonistas de los receptores de la angiotensina (ARAII) o inhibidores de la renina.
    • Trastorno infiltrativo o por depósito como enfermedad de Fabry, o amiloidosis
    • Enfermedades coronarias sintomáticas conocidas o sospechadas o evidencia de infarto de miocardio previo
    • Presión arterial sistólica <100 mmHg o hipotensión sintomática durante el periodo de selección/basal o el periodo de tratamiento de preinclusión.
    •Contraindicación a la administración de ARAII, o antecedentes de
    angioedema.
    •Hipertensión no controlada persistente
    Se pueden aplicar otros criterios de inclusión / exclusión definidos por el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in peak VO2 as measured by cardiopulmonary exercise test (CPET)
    Cambio desde el valor basal en el VO2 máximo medido por la prueba de ejercicio cardiopulmonar (CPET)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to 50 weeks
    Basal a 50 semanas
    E.5.2Secondary end point(s)
    Adverse events (AEs), vital signs, ECGs, physical examinations and safety labs
    Efectos adversos (AE), signos vitales, ECG, exámenes físicos y laboratorios de seguridad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over numerous visits until end of study
    Durante numerosas visitas hasta el final del estudio
    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 No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    Tolerabilidad
    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) 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 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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Finland
    Germany
    Greece
    Korea, Republic of
    Spain
    United Kingdom
    United States
    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
    Study completion is defined as when the last patient finishes their EOS/Study Completion visit and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator or, in the event of an early study termination decision, the date of that decision.
    La finalización del estudio se define cuando el último paciente finaliza su visita EOS / Finalización del estudio y cualquier evaluación repetida asociada con esta visita ha sido documentada y seguida adecuadamente por el investigador o, en el caso de una decisión de finalización temprana del estudio, la fecha de esa decisión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days13
    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.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 44
    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)
    There are no plans for treatment after the subject ends the participation in the trial.
    No hay planes de tratamiento después de que el sujeto finalice la participación en el ensayo
    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 Decision2020-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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