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    Summary
    EudraCT Number:2007-002422-29
    Sponsor's Protocol Code Number:1235.8
    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:2007-11-30
    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 number2007-002422-29
    A.3Full title of the trial
    Estudio de seguimiento abierto de eficacia y seguridad de la administración crónica de comprimidos con la combinación de telmisartán 40 mg + amlodipino 10 mg o de la combinación de telmisartán 80 mg + amlodipino 10 mg, solo o en combinación con otras medicaciones antihipertensivas en pacientes con hipertensión

    An open-label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40mg + amlodipine 10mg or the combination of telmisartan 80mg + amlodipine 10mg tablets alone or in combination with other antihypertensive medications in patients with hypertension
    A.4.1Sponsor's protocol code number1235.8
    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 SponsorBoehringer Ingelheim España, 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 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 nametelmisartan/amlodipine (40mg/10mg) fixed-dose combination
    D.3.2Product code T40/A10
    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 INNtelmisartan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNamlodipine
    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: 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 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 nametelmisartan/amlodipine (80mg/10mg) fixed-dose combination
    D.3.2Product code T80/A10
    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 INNtelmisartan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNamlodipine
    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.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
    Hipertensión esencial
    essential hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015488
    E.1.2Term Essential hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia y seguridad de la combinación a dosis fija de telmisartán 40mg/ amlodipino 10 mg (T40/A10) o telmisartán 80mg/amlodipino 10mg (T80/A10) en tratamiento abierto durante al menos seis meses.
    E.2.2Secondary objectives of the trial
    Un objetivo adicional es valorar la eficacia y seguridad de la administración de T40/A10 o T80/A10 conotros tratamientos habitualmente utilizados para el tratamiento de la hipertensión.
    Las variables de eficacia incluyen los cambios en la PAD y la PAS en sedestación, proporción de pacientes que logran el control de la PAD, respuesta de la PAD, respuesta de la PAS y proporción de pacientes con una presión arterial óptima, normal, normal-alta y alta.
    La seguridad se controlará mediante la valoración de los parámetros analíticos, electrocardiograma de 12 derivaciones y los acontecimientos adversos notificados.
    Las variables de eficacia y seguridad de T40/A10 se compararán con las de T80/A10.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. hombres y mujeres de edad igual o superior a 18 años en el momento de otorgar el consentimiento informado.
    2. diagnóstico de hipertensión esencial y presión arteial no controlada adecuadamente antes de otorgar el consentimiento informado para el estudio precedente 1235.6 (EudraCT 2007-002421-68). (Control inadecuado se define como PAD en sedestación ≥ 95 mmHg si está recibiendo tratamiento contra la hipertensión o PAD en sedestación ≥ 100 mmHg si no ha recibido tratamiento.)
    3. falta de respuesta al tratamiento tras seis semanas con monoterapia de amlodipino 10mg en el periodo de selección del ensayo precedente 1235.6 (EudraCT 2007-002421-68). (La falta de respuesta se define como PAD en sedestación ≥ 90 mmHg.)
    4. haber sido aleatorizados para el ensayo precedente 1235.6 (EudraCT 2007-002421-68) y haber finalizado el ensayo en los 14 días anteriores a la visita 1.
    5. buena disposición y capacidad de otrogar el consentimiento informado por escrito (conforme a la Buena Práctica Clínica y la legislación local).
    E.4Principal exclusion criteria
    1. embarazo, lactancia, mujeres potencialmente fértiles que no utilicen un método anticonceptivo aceptable durante el estudio y que no consientan en someterse a pruebas de embarazo durante su participación en el mismo.
    2. desarrollo de cualquier condición clínica en el estudio precedente 1235.6 (EudraCT 2007-002421-68) que, en opinión del investigador, pudiera empeorar con el tratamiento con T40/A10 o T80/A10.
    3. interrupción del estudio precedente 1235.6 (EudraCT 2007-002421-68) bdebido a un acontecimiento adverso o cualquier otro motivo.
    4. hipertensión secunaria conocida o sospechada.
    5. PAS media en sedestación ≥ 180 mmHg y/o PAD media en sedestación ≥ 120 mmHg en cualquier visita.
    6. disfunción hepática clínicamente significativa.
    7. disfunción renal grave, estenosis bilateral de la arteria renal, estenosis de la arteria renal en un riñón único, pacientes sometidos a trasplante renal o con un solo riñón funcional.
    8. hiperpotasemia clínicamente relevante.
    9. depleción de volumen o de sodio no corregidas.
    10. aldosteronismo primario.
    11. intolerancia hereditaria a la fructosa o a la lactosa.
    12. insuficiencia cardiaca congestiva sintomática (clase funcional III-IV de la New York Heart Academy).
    13. pacientes que hayan experimentado previamente síntomas característicos de angioedema durante el tratamiento con inhibidores de la ECA o ARAs.
    14. aparición de toxicomanía o alcoholismo desde la firma del consentimiento informado del ensayo precedente 1235.6 (EudraCT 2007-002421-68).
    15. participación simultánea en otro ensayo clínico o toma de cualquier tratamiento en investigación desde la finalización del ensayo precedente 1235.6 (EudraCT 2007-002421-68).
    16. cardiomiopatía obstructiva hipertrófica, estenosis de la válvula aórtica o mitral hemodinámicamente relevante.
    17. hipersensibilidad alérgica conocida a algún componente de las formulaciones en estudio.
    18. incumplimiento de la pauta de medicación del estudio (definido como menos del 80% o más del 120%) durante el ensayo precedente 1235.6 ( EudraCT 2007-002421-68) .
    19. administración de ARAs o calcio-antagonistas dihidropirínicos en cualquier momento durante el estudio (aparte de la medicación del ensayo).
    20. cualquier otra condición clínica que, a juicio del investigador, no permita el cumplimiento seguro del protocolo y la administración segura de telmisartán o amlodipino.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la proporción de pacientes que logran controlar al PAD (definida como PAD valle media en sedestación < 90 mmHg, es decir, aproximadamente 24 horas después de la última dosis de la medicación del estudio) tras seis meses de tratamiento o en la última observación valle durante el periodo de tratamiento (es decir, criterio de la última observación considerada LOCF).
    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 Yes
    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) Yes
    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 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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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 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
    Finalización del estudio es la fecha en que el último paciente finaliza el tratamiento

    End of trial is date of last patient completing treatment
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 434
    F.4.2.2In the whole clinical trial 680
    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)
    usual care
    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 Decision2008-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-19
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