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    Summary
    EudraCT Number:2009-012966-30
    Sponsor's Protocol Code Number:DSE-SEV-02-09
    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:2009-09-17
    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 number2009-012966-30
    A.3Full title of the trial
    “Eficacia de Sevikar® comparado con la combinación de Perindoprilo/Amlodipino sobre la Presión Arterial Central, en Pacientes con Hipertensión moderada a severa - SEVITENSION”
    A.4.1Sponsor's protocol code numberDSE-SEV-02-09
    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 SponsorDAIICHI SANKYO EUROPE GmbH
    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 Yes
    D.2.1.1.1Trade name SEVIKAR 40 mg/10 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderDAIICHI SANKYO ESPAÑA, S.A.
    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 Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAMLODIPINO BESILATO
    D.3.9.3Other descriptive nameAMLODIPINE BESILATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLMESARTAN MEDOXOMILO
    D.3.9.1CAS number 144689-63-4
    D.3.9.3Other descriptive nameOLMESARTAN MEDOXOMIL
    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) 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.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 ANTACAL
    D.2.1.1.2Name of the Marketing Authorisation holderERREKAPPA EUROTERAPICI SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Information not present in EudraCT
    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 INNAmlodipino
    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) 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.IMP: 3
    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 PRENESSA
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA, tovarna zdravil, d.d.
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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 Information not present in EudraCT
    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 INNPerindopril butamina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboCoated 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 placeboTablet
    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 placeboTablet
    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
    Eficacia de Sevikar® comparado con la combinación de Perindoprilo/Amlodipino sobre la Presión Arterial Central, en Pacientes con Hipertensión moderada a severa - SEVITENSION
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10015491
    E.1.2Term Essential hypertension, unspecified
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo primario del estudio consiste en demostrar la no inferioridad de OM/AM 40/10 mg (Sevikar®) en comparación con la combinación de PER 8 mg más AM 10 mg en el efecto sobre la variación media de la Presión Arterial Sistólica Central (PASC) desde la evaluación basal (Semana 0) hasta el examen final (Semana 24, metodología LOCF).
    E.2.2Secondary objectives of the trial
    Variación desde semana 0 a 24 en la MAPA.
    Variación desde semana 0 a 24 en la media de la PAS y PAD convencional en posición sentada.
    Variación en la PASC desde semana 12 a 24 en pacientes con la PA estabilizada entre Semana 12 y 18.
    Variación desde Semana 12 a 24 en la media PAS y PAD convencional estabilizada entre Semana 12 y 18 en posición sentada.
    Número de pacientes normalizados en Semana 24.
    Número de respondedores en Semana 24, normalizados o con una reducción de PAS convencional de al menos 20 mmHg o PAD convencional de al menos 10 mmHg.
    Evaluar la relación entre la media de la PAS convencional en posición sentada la PASC y la MAPA sistólica, basado en las variaciones desde Semana 0 a 24.
    Evaluar la relación entre la media de la PAD convencional en posición sentada y la MAPA diastólica, basado en las variaciones desde la Semana 0 a 24.
    Incidencia y perfil de Acontecimientos Adversos (AA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Varones y mujeres de raza blanca >= 40 años y <=80 años de edad en el momento de la inclusión;
    2.Presencia de al menos 3 de los factores de riesgo siguientes en el momento de la inclusión:
    Edad: hombres < 55 años; mujeres > 65 años;
    Consumo de tabaco: fumador actual o ex fumadores de menos de 1 año;
    Dislipemia:
    -TC > 5.0 mmol/l (190 mg/dl) o
    -LDL-C > 3.0 mmol/l (115 mg/dl) o
    -HDL-C: hombre < 1.0 mmol/l (40mg/dl); mujer < 1.2 mmol/l (46 mg/dl) o
    -TG > 1.7 mmol/l (150 mg/dl)
    Diabetes tipo 2;
    Valores anómalos de GGT/ aumento de la glucosa plasmática en ayunas;
    Obesidad abdominal: perímetro de cintura, hombres > 102cm; mujer > 88 cm;
    Antecedentes familiares de enfermedad coronaria precoz: hombres de edad < 55 años y mujeres de edad < 65 años;
    Hipertrofia del ventrículo izquierdo
    -HVI electrocardiográfica (Sokolow-Lyon > 38 mm; Cornell > 2440 mm*ms) o
    -HVI ecocardiográfica (HVI en hombres >= 125 g/m2, mujeres >= 110 g/m2);
    Enfermedad cerebrovascular
    -Ictus isquémico
    -Hemorragia cerebral
    -Ataque isquémico transitorio;
    Enfermedad cardiaca
    -Infarto de miocardio
    -Angina
    -Revascularización coronaria
    -Fallo cardíaco;
    Retinopatía avanzada
    -Hemorragias o exudados
    -Papiloedema;
    Ateroesclerosis (incl. enfermedad arterial periférica);
    Enfermedad renal
    -Nefropatía diabética
    -Insuficiencia renal (creatinina en plasma: hombre > 1.3 mg/dl; mujer > 1.2 mg/dl)
    -Índice de filtrado glomerular < 60 ml/min/1.73 m2 o aclaramiento de creatinina < 60 ml/min
    -Microalbuminuria > 30 mg/24 h
    -Proteinuria > 300 mg/24 h;

    3.Pacientes con hipertensión de moderada a grave en el momento de su inclusión al estudio, definida por:
    -PAS >= 160 y <= 200 mmHg o PAD >= 100 y <= 115 mmHg, en pacientes no tratados, o
    -PAS >= 140 mmHg o PAD >= 90 mmHg, en pacientes con tratamiento previo, o
    -PAS >= 130 mmHg o PAD >= 80 mmHg en diabéticos/ERC;
    4.Pacientes que han dado libremente su consentimiento informado por escrito, después de habérseles explicado la naturaleza del estudio y el tratamiento de sus datos.
    E.4Principal exclusion criteria
    1.Hipertensión secundaria o maligna.
    2.Contraindicación de alguna de las medicaciones del estudio.
    3.Aclaramiento de creatinina < 40 ml/min.
    4.Pacientes en tratamiento con más de 3 fármacos antihipertensivos.
    5.El paciente necesita tomar cualquier otro fármaco que también es eficaz para la hipertensión (p. ej., un alfabloqueante para la enfermedad prostática).
    6.Infarto de miocardio, Angioplastia coronaria transluminal percutanea (ACTO) o bypass de la arteria coronaria (BAC) en los 6 meses previos a la inclusión en el estudio.
    7.Angina de pecho inestable.
    8.Accidente cerebrovascular, ataque isquémico transitorio (AIT) o cirugía cerebrovascular en los 3 meses previos a la inclusión en el estudio.
    9.Bloqueo auriculoventricular (AV) de segundo o tercer grado.
    10.Insuficiencia cardiaca congestiva con clasificación II-IV de la NYHA.
    11.Arritmias incontroladas
    12.Enfermedad hematológica, gastrointestinal, hepática, renal o de otro tipo, concomitante y clínicamente importante, que pudiera interferir con la capacidad del paciente para completar el estudio.
    13.Pacientes insuficientemente tratados con tres antihipertensivos diferentes y con lesiones clínicamente relevantes en órganos diana.
    14.Antecedentes de alcoholismo, abuso de drogas, psicosis, cambios de personalidad, enfermedades psiquiátricas, baja motivación u otros problemas emocionales o intelectuales que puedan invalidar el consentimiento informado.
    15.Mujeres embarazadas o mujeres en situación fértil (antes de la menopausia durante al menos un año) que no utilicen un método anticonceptivo fiable (por ejemplo, dispositivo intrauterino (DIU), píldora anticonceptiva o métodos de barrera) desde al menos 3 meses antes de la incorporación al estudio, o mujeres que estén dando el pecho.
    16.Anomalías clínicamente relevantes en la analítica basal o de preinclusión.
    17.Participación en otro ensayo clínico, actualmente o en el periodo de un mes antes de la incorporación al estudio.
    17.Participación en este estudio como personal del centro de investigación.
    19.Pacientes que difícilmente puedan cumplir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Variación media de la PASC desde la evaluación basal (Semana 0) hasta el examen final (Semana 24), empleando la metodología de última observación realizada (LOCF; Last Observation Carried Forward)
    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 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 Yes
    E.8.1.7.1Other trial design description
    Doble Enmascaramiento
    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.8.3 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 concerned13
    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
    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 months6
    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 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 state720
    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 Decision2009-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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