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    Summary
    EudraCT Number:2011-005979-16
    Sponsor's Protocol Code Number:PrOvAS001
    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:2012-09-14
    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 number2011-005979-16
    A.3Full title of the trial
    PREECLAMPSIA OF PREVENTION IN PATIENTS THROUGH ovodonation aspirin in early gestation
    PREVENCIÓN DE PREECLAMPSIA EN PACIENTES DE OVODONACIÓN MEDIANTE LA ADMINISTRACIÓN DE ASPIRINA EN LA GESTACIÓN TEMPRANA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of preeclampsia in oocyte donation WOMEN BY THE ADMINISTRATION OF ASPIRIN IN EARLY PREGNANCY
    PREVENCIÓN DE PREECLAMPSIA EN MUJERES DE OVODONACIÓN MEDIANTE LA ADMINISTRACIÓN DE ASPIRINA EN LA GESTACIÓN TEMPRANA
    A.4.1Sponsor's protocol code numberPrOvAS001
    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 SponsorInstituto de Investigación Sanitaria La Fe
    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 supportInstituto de Investigacion Sanitaria La Fe
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigacion Sanitaria La Fe
    B.5.2Functional name of contact pointUREC
    B.5.3 Address:
    B.5.3.1Street AddressAv. Campanar 21
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46009
    B.5.3.4CountrySpain
    B.5.4Telephone number34963862758
    B.5.5Fax number3496349 44 16
    B.5.6E-mailinvestigacion_clinica@iislafe.es
    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 Aspirin
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Hispania S.L
    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 nameAspirin
    D.3.2Product code N02B A01
    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 INNAcido acetilsalicílico
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor code AAS
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    PREECLAMPSIA
    PREECLAMPSIA
    E.1.1.1Medical condition in easily understood language
    PREECLAMPSIA
    PREECLAMPSIA
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to study the occurrence of preeclampsia in patients receiving
    aspirin-treated oocyte donation early and compare the results with those obtained in
    patients receiving placebo
    El objetivo principal es estudiar la aparición de preclampsia en pacientes
    beneficiarias de ovodonación tratadas con aspirina de forma precoz y comparar los
    resultados con los obtenidos en pacientes que reciban placebo
    E.2.2Secondary objectives of the trial
    determine the development of gestational hypertension, preeclampsia severe CIR
    and preterm delivery in this group of patients. Also in this study is to find whether,
    ASA by blocking cyclo-oxygenase-2 could act in addition to reducing the synthesis
    of thromboxane A 2, by modifying or reducing the formation of various inflammatory
    mediators involved in angiogenesis
    determinar el desarrollo de hipertensión gestacional, preclampsia severa, CIR y
    parto pretérmino en este grupo de pacientes. También se pretende en este estudio
    hallar si, el AAS a través del bloqueo de la ciclo-oxigenasa 2 podría actuar, además
    de reduciendo la síntesis de tromboxano 2, modificando o disminuyendo la
    formación de diversos mediadores inflamatorios que intervienen en la angiogénesis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients over 18 years. - Patients receiving oocyte donation. - Patients who have
    become pregnant. - Single or multiple gestations. - To accept the conditions of the
    study by signing the appropriate informed consent
    single pregnancies
    Pacientes mayores de 18 años. - Pacientes beneficiarias de ovodonación. -
    Pacientes que hayan quedado embarazadas. - Gestaciones únicas o múltiples. -
    Que acepten las condiciones del estudio mediante la firma del consentimiento
    informado correspondiente
    Gestaciones únicas
    E.4Principal exclusion criteria
    Known allergy to ASA. - History of peptic ulcer. - Use of prostaglandin inhibitors
    within 10 days before the start of the study. - History of chronic renal disease,
    thyroid, liver or heart disease. - Psychiatric or cognitive pathology that prevents the
    understanding of the conditions of informed consentKnown allergy to ASA. - History of peptic ulcer. - Use of prostaglandin inhibitors
    within 10 days before the start of the study. - History of chronic renal disease,
    thyroid, liver or heart disease. - Psychiatric or cognitive pathology that prevents the
    understanding of the conditions of informed consent
    Alergia conocida al AAS. - Historia de úlcera péptica. - Uso de inhibidores de las
    prostaglandinas dentro de los 10 días previos al inicio del estudio. - Historia de
    patología crónica renal, tiroidea, hepática o cardíaca. - Patología psiquiátrica o
    cognitiva que impida la comprensión de las condiciones del consentimiento
    informado.
    E.5 End points
    E.5.1Primary end point(s)
    Family history of preeclampsia or CIR. - Medical history (hypertension, diabetes
    mellitus ...) and surgical - Allergy to medicines. - Current treatment and previous
    treatments used. - Obstetric history. - Gynecological history. - Age of the patient. -
    Weight and height, calculation of BMI. - Raza. - Smoking. - Determination of weight
    gain during pregnancy and physical examination to detect the potential occurrence
    of edema. - Determination of Blood Pressure and Proteinuria: determine the value
    the blood pressure and protein in urine throughout pregnancy at intervals of one
    month (in order to detect gestational hypertension Pre-eclampsia). Blood pressure
    measurement by digital sphygmomanometer. To evaluate the presence of protein in
    urine by conducting strips, and if it detects two crosses, proceed to the request of
    abnormal urinary sediment. - Analytical Basic throughout pregnancy intervals of
    three months (in order to identify criteria for severity). - Ultrasound Findings: length
    cefalonalga (LCN), nuchal translucency (NT), fetal biometry estimated fetal weight
    (PFE) and ductus venosus Doppler study, umbilical artery and MCA in normal
    controls (in order to detect CIR). It also performed uterine artery Doppler study
    between 11 and 13 weeks of gestation to determine the pulsatility index. -
    Determination maternal plasma: PAPP-A and beta-HCG (in weeks 11-13). -
    Determination maternal plasma VEGF, PlGF, sFlt-1 and sEng in 2 times (11-13
    weeks, and weeks 18-22). - Gestational age at the time of termination, fnalización
    mode, sex and birth weight, Apgar score
    Antecedentes familiares de preclampsia o CIR. - Antecedentes médicos (HTA,
    diabetes mellitus?) y quirúrgicos - Alergias a medicamentos. - Tratamiento actual y
    tratamientos previos empleados. - Historia obstétrica. - Historia ginecológica. - Edad
    de la paciente. - Peso y talla; cálculo del IMC. - Raza. - Tabaquismo. -
    Determinación de la ganancia ponderal durante la gestación y exploración física
    con el fin de detectar la aparición de posibles edemas. - Determinación de Presión
    arterial y Proteinuria: determinaremos la presión arterial y valoraremos la presencia
    de proteínas en orina durante todo el embarazo con intervalos de un mes; (con el
    fin de detectar Hipertensión gestacional o Preclampsia). Determinaremos la presión
    arterial mediante el esfigmomanómetro digital. Valoraremos la presencia de
    proteínas en orina mediante la realización de tiras reactivas; y en caso de detectar
    dos cruces, procederemos a la petición de Anormales y Sedimento de orina. -
    Analítica básica: durante todo el embarazo con intervalos de tres meses (con el fin
    de detectar criterios de severidad). - Hallazgos ecográficos: longitud cefalonalga
    (LCN), translucencia nucal (TN), Biometría fetal con peso fetal estimado ( PFE) y
    estudio Doppler del ductus venoso, arteria umbilical y ACM en los controles
    habituales (con el fin de detectar CIR). Además se realizará estudio Doppler de
    arterias uterinas entre las semanas 11 y 13 de gestación para determinar el índice
    de pulsatilidad. - Determinación en plasma materno de: PAPP-A y beta-HCG (en
    semana 11-13). - Determinación en plasma materno de VEGF, PIGF, sFlt-1 y sEng
    en 2 ocasiones (en semana 11-13; y en semana 18-22). - Edad gestacional en el
    momento de la finalización, modo de fnalización, sexo y peso del recién nacido,
    Índice de Apgar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Completion of gestiacion
    Finalizaacion de la gestiacion.
    E.5.2Secondary end point(s)
    Family history of preeclampsia or CIR. - Medical history (hypertension, diabetes
    mellitus ...) and surgical - Allergy to medicines. - Current treatment and previous
    treatments used. - Obstetric history. - Gynecological history. - Age of the patient. -
    Weight and height, calculation of BMI. - Raza. - Smoking. - Determination of weight
    gain during pregnancy and physical examination to detect the potential occurrence
    of edema. - Determination of Blood Pressure and Proteinuria: determine the value
    the blood pressure and protein in urine throughout pregnancy at intervals of one
    month (in order to detect gestational hypertension Pre-eclampsia). Blood pressure
    measurement by digital sphygmomanometer. To evaluate the presence of protein in
    urine by conducting strips, and if it detects two crosses, proceed to the request of
    abnormal urinary sediment. - Analytical Basic throughout pregnancy intervals of
    three months (in order to identify criteria for severity). - Ultrasound Findings: length
    cefalonalga (LCN), nuchal translucency (NT), fetal biometry estimated fetal weight
    (PFE) and ductus venosus Doppler study, umbilical artery and MCA in normal
    controls (in order to detect CIR). It also performed uterine artery Doppler study
    between 11 and 13 weeks of gestation to determine the pulsatility index.Determination maternal plasma: PAPP-A and beta-HCG (in weeks 11-13). -
    Determination maternal plasma VEGF, PlGF, sFlt-1 and sEng in 2 times (11-13
    weeks, and weeks 18-22). - Gestational age at the time of termination, endingmode, sex and birth weight, Apgar score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Completion of gestiacion
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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 concerned2
    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
    Abortion or ectopic pregnancy. No medication compliance. No compliance
    with routine visits of Obstetrics CCEE. ? Adverse reaction to aspirin
    Aborto o gestación ectópica. No cumplimento de la medicación. No
    cumplimento de las visitas de rutina en CCEE de Obstetricia. Reacción adversa a
    la aspirina.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    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: 372
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.3Pregnant women Yes
    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 state136
    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)
    Normal treatment
    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 Decision2013-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-20
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