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    Summary
    EudraCT Number:2011-004760-29
    Sponsor's Protocol Code Number:UIAPB-TAHPS-2011-01
    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:2011-11-22
    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 number2011-004760-29
    A.3Full title of the trial
    EFFECTIVENESS OF ADMINISTRATION TIMING OF ASPIRIN FROM DAYTIME TO NIGHTIME IN HYPERTENSIVE PATIENTS TREATED WITH LOW DOSE OF ASA IN SECONDARY PREVENTION. - TAHPS
    ?Efectividad de la Temporización de la administración nocturna de Aspirina frente a la diurna en pacientes Hipertensos en tratamiento con bajas dosis de AAS como Prevención Secundaria. ? TAHPS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness decreasing hypertension when aspirin drug's administration schedule is at night.
    Efectividad en la reducción de hipertensión del fármaco AAS cuando la pauta de administración es nocturna.
    A.3.2Name or abbreviated title of the trial where available
    hypertension and ASA
    hipertension y aspirina
    A.4.1Sponsor's protocol code numberUIAPB-TAHPS-2011-01
    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 SponsorMaria Victoria Ruiz Arzalluz
    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 supportsupported by the Spanish Ministry of Health
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Atención Primaria de Bizkaia
    B.5.2Functional name of contact pointNatalia Burgos-Alonso
    B.5.3 Address:
    B.5.3.1Street Addressc/Luis Power 18 4ªplanta
    B.5.3.2Town/ cityBilbao
    B.5.3.3Post code48014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034946006637
    B.5.6E-mailnatalia.burgosalonso@osakidetza.net
    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 Acetylsalicylic acid 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderlaboratorium sanitatis
    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.3.1Product nameacetylsalicylic acid
    D.3.2Product code C0036079
    D.3.4Pharmaceutical form 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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 100
    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 Yes
    D.3.11.13.1Other medicinal product typechemical product
    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 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
    hypertension
    hipertension
    E.1.1.1Medical condition in easily understood language
    high blood preassure
    alta presión arterial
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020775
    E.1.2Term Hypertension arterial
    E.1.2System Organ Class 10047065 - Vascular 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 evening administration of low doses of aspirin (100 mg) on the BP of hypertensive patients with high cardiovascular risk, comparing with the effect of day administration, estimated by calculating the mean SBP and DBP measured over a 24 hour period
    Evaluar el efecto hipotensor de la administración nocturna de bajas dosis de aspirina en hipertensos, de alto RCV en tratamiento farmacológico y preventivo secundario con bajas dosis de AAS, para conseguir optimizar su tratamiento habitual y reducir el RCV, mediante el calculo de la medio de tensión arterial sistólica y diastólica (TAS, TAD)
    E.2.2Secondary objectives of the trial
    ? To optimize the control of BP in hypertensive patients treated with low doses of aspirin for secondary prevention.

    ? To compare the hypotensive effect of evening administration of low dose of aspirin in different subgroups, as a function of age, sex, and values of serum creatinine.

    ? To estimate the percentage of non-dippers and dippers among the population of hypertensive patients at high cardiovascular risk.

    ? To identify any changes in heart rate (HR) and pulse pressure (PP) with evening administration of ASA.

    ? To describe the changes in day-night pattern of BP as a function of the time of administration of low doses of aspirin in non-dipper patients, objectified by the day:night SBP and DBP ratios.

    ? To assess any changes in the side effects of aspirin when taken in the evening compared to day-time administration.
    Comparar el efecto hipotensor de la administración nocturna de AAS en los diferentes subgrupos: edad, sexo, valores de creatinina sérica, etc.

    Determinar posibles modificaciones en la frecuencia cardiaca (FC) y en la presión de pulso (PP) tras la administración nocturna de AAS.

    Estimar la modificación del patrón noche/día de la TA tras la administración temporizada de bajas dosis de AAS en los pacientes non-dipper.

    Valorar los posibles cambios en los efectos secundarios del AAS en administración nocturna comparada con la diurna.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All participants are to be hypertensive patients (?140/90) between 18 and 80 years old who are currently taking low doses of ASA, for secondary prevention of cardiovascular events
    - Pacientes hipertensos >18 and <80años en tratamiento actual con bajas dosis de AAS en prevención secundaria de eventos cardiovasculares
    E.4Principal exclusion criteria
    Severe and/or terminal illness
    Congestive heart failure (CHF)
    Moderate/severe chronic renal failure
    Physical or mental illness that prevents the patient´s collaboration
    Being a heavy drinker, consuming more than 280 g of alcohol per week in the case of men or 170 g for women31
    Concomitant treatment with other antiplatelets or anticoagulants
    Taking NSAIDs on a regular basis
    Treatment with ASA at doses outside those established in the inclusion criteria (above)
    ASA already being taken in the evening
    Being a shift worker or having a very intensive work schedule
    Hospital admission during the clinical trial
    -Enfermedad grave y/o Terminal.
    -Trastorno físico o mental que impida la colaboración del paciente.
    -Tratamiento con otros antiagregantes o anticoagulantes simultáneamente.
    -Tratamiento con AAS a dosis distinta de la del criterio de inclusión.
    -Pacientes que ya toman el AAS en dosis nocturna.
    -Trabajadores a turnos o con actividad laboral nocturna muy intensa.
    -Modificaciones en el tratamiento del paciente durante los 7 meses de duración del ensayo.
    -Ingreso del paciente durante el periodo de ensayo.
    -Bebedor importante, de más de 280 gr de alcohol a la semana en varones y más de 170 gr de alcohol a la semana en mujeres.
    -Toma de antiinflamatorios no esteroideos (AINEs) de forma habitual
    -Pacientes con Insuficiencia Cardiaca Congestiva (ICC) o Insuficiencia Renal Crónica en grado moderado o severo
    E.5 End points
    E.5.1Primary end point(s)
    Blood Preasure
    Tensión arterial
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline
    after first period
    after washout
    after the second period(final of the study)
    periodo basal
    despues del primer periodo
    despues del lavado
    despues del segundo periodo(final del estudio)
    E.5.2Secondary end point(s)
    Hematologic analysis
    Adverse effects
    analisis hematologico
    efectos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Hematologic analysis:
    baseline and at the end of the study
    Adverse effects: monthly
    analisis hematologicos:
    En el periodo basal y al final del estudio
    Efectos adversos: mensualmente
    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 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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned6
    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 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
    The last visit will be when the last hematological analysis of the last patient will bedone. If the hematological analysis is wrong the trial will be not concluded until the analysis is normalized or modicications are not clinically relevant in the view of IP.
    La última visita será despues de realizar la analitica al último paciente que entre en el ensayo. Si la analitica esta alterada no se dara por concluido el ensayo hasta que no se normalice o las modicicaiones no sean clinicamente relevantes a juicio del IP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    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 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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state258
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    F.4.2.2In the whole clinical trial 258
    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)
    The medication problems will be solved stoping the treatment
    Si hubiera algun problema a consecuencia del tratamiento se interrumpiria el ensayo para ese paciente
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation unidad de investigacion de Atencion Primaria de Bizkaia
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
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