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    Summary
    EudraCT Number:2015-005130-22
    Sponsor's Protocol Code Number:FFIS/2015/01/ST
    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:2016-07-15
    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 number2015-005130-22
    A.3Full title of the trial
    Randomised Controlled Trial with Pravastatin versus Placebo for Prevention of Pre-eclampsia STATIN
    Estudio controlado aleatorizado con pravastatina versus placebo para la prevención de preeclampsia (estudio STATIN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of pre­eclampsia (high blood pressure): Randomised trial of Pravastatin versus placebo
    Prevención de preeclampsia (alta presión sanguínea):Estudio randomizado de Pravastatina frente a Placebo.
    A.3.2Name or abbreviated title of the trial where available
    STATIN
    STATIN
    A.4.1Sponsor's protocol code numberFFIS/2015/01/ST
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN17787139
    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 SponsorFundación para la Formación e Investigación Sanitaria (FFIS)
    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 supportFetal Medicine Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFFIS
    B.5.2Functional name of contact pointLola Serna Guirao
    B.5.3 Address:
    B.5.3.1Street AddressLuis Fontes Pagán 9
    B.5.3.2Town/ cityMurcia
    B.5.3.3Post code30003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034968359763
    B.5.5Fax number968359777
    B.5.6E-maillola.serna@carm.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 Pravastatina 20 mg
    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 namePravastatin
    D.3.4Pharmaceutical form Capsule
    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 INNPravastatin Sodium
    D.3.9.3Other descriptive namePravastatina 20mg
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Pre-eclampsia
    Pre - eclampsia
    E.1.1.1Medical condition in easily understood language
    Raised blood pressure in pregnancy as a result of abnormal function of the placenta
    La tensión arterial elevada durante el embarazo como resultado de la función anormal de la placenta
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10036485
    E.1.2Term Pre-eclampsia
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine if the use of Pravastatin starting at 11­-14 weeks' gestation in women at increased risk of developing pre­-eclampsia (high blood pressure in pregnancy) reduces the incidence and severity of this complication.
    Examinar si el uso de pravastatina a partir de la gestación de 11-14 semanas en mujeres con alto riesgo de desarrollar preeclampsia (presión arterial alta durante el embarazo) reduce la incidencia y gravedad de esta complicación.
    E.2.2Secondary objectives of the trial
    To examine if the use of Pravastatin reduces the incidence of early delivery due to complications from high blood pressure, fetal growth restriction, stillbirth or neonatal complications, rate of neonatal intensive care unit admission, the incidence of placental abruption (separation) and spontaneous preterm delivery before 34 weeks and 37 weeks.
    Examinar si el uso de pravastatina reduce la incidencia de parto antes de tiempo debido a las complicaciones de la hipertensión arterial, la restricción del crecimiento fetal, complicaciones fetal o neonatal, tasa de neonatal unidad de cuidados intensivos de admisión, la incidencia de desprendimiento de la placenta (separación) y parto prematuro espontáneo antes de las 34 semanas y 37 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years;

    • Singleton pregnancies;

    • Live fetus at 11-13 weeks of gestation;

    • High-risk for preterm-PE at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (placental growth factor);

    • Be fluent in the local language (otherwise interpreters will be used);

    • Informed and written consent.
    - Edad ≥ 18 años
    - Embarazos únicos
    - Feto vivo entre las semanas 11-13
    - Alto riesgo para PE precoz calculado entre las semanas 11-13, calculado mediante la combinación de la historia materna, la tensión arterial media y el Doppler de las arterias uterinas, junto con marcadores bioquímicos (factor de crecimiento placentario,PLGF)
    - Las pacientes que no hablen español o inglés, se les proporcionará un intérprete.
    - Consentimiento informado y por escrito
    E.4Principal exclusion criteria
    • Statin use in current pregnancy (administration must have ceased >28 days prior to randomisation);

    • Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks’ assessment;

    • Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness;

    • Women with contraindications for statin therapy:

    • Hypersensitivity to Pravastatin or any component of the product;

    • Active liver disease in the past 6 months (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes (≥two times higher than the upper limit of normal values for serum transaminases [ALT and/or AST], confirmed either by available blood results within the recruiting hospital within the last 6 months or blood taken prior to randomisation));

    • History of myopathy or rhabdomyolysis;

    • Women with any of the following conditions:

    • Status post solid organ transplant;

    • Chronic renal disease/insufficiency with baseline serum creatinine >1.5mg/dL;

    • Cancer;

    • Concurrent and chronic (>6 months) use of medications with potential drug interactions with statins, such as immunosuppressive drugs, fibrates, gemfibrozil, niacin, protease inhibitors, efavirenz (non-nucleoside reverse transcriptase inhibitor), erythromycin, clarithromycin, itraconazole, cholestyramine, digoxin, rifampicin (patients will not be excluded if the drug has been discontinued, or is prescribed for a short duration of time);

    • Participating in another intervention study that influences the outcomes of this study;

    • Plans to deliver in a non-network site,

    • Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
    -Uso de estatinas en este embaraz (la administración debe hacer cesado como mínimo 28 días antes de la randomización).

    - Diagnóstico de malformaciones importantes entre las semanas 11-13 de gestación.

    - Mujeres severamente enfermas o problemas mentales.
    - Mujeres con contraindicaciones para el tratamiento con estatinas:
    - Hipersensibilidad a las estatinas u otros componentes del producto.
    - Enfermedad hepática activa en los 6 meses anteriores (hepatitis aguda, hepatitis activa crónica)Elevación inexplicada (1.5 x normal) de las transaminasas ALT, AST), confirmado mediante un análisis de sangre en los 6 meses previos o en una analítica previa al estudio o una analítica previa al estudio o ictericia.
    - Historia personal o familiar de miopatía o rabdomiolisis.
    - Mujeres con algunas de las siguientes condiciones médicas:
    - Estado de post-transplante de organos sólidos.
    - Enfermedad renal crónica/insuficiencia renal con una creatinina basal ≥1.5 mg/dL
    - Cáncer

    Uso crónico (>6 meses) de medicamentos con potencial interacción con estatinas, tales como drogas inmunosupresoras, gemfibrozilo, niacin, eritromicina, itraconazol, colestiramina, digoxina, rifampicina (las pacientes no se excluirán si la medicación se ha suspndidio).
    - Participación en otro estudio de intervención que influye en los resultados de este estudio;
    - Planes de parto en una ciudad o país diferente.
    - Cualquier otra razón que el investigador considere.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of preterm pre­eclampsia (< 37 weeks).
    La incidencia de la preeclampsia pretérmino (<37 semanas).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once delivered, data on pregnancy outcome, including labour onset, gestational age at delivery, mode of delivery, development of hypertension in pregnancy, neonatal birth weight and gender, and other obstetrics complications, will be collected from the hospital maternity records or their general medical practitioners. In addition, the obstetric records of women with pre-­existing or pregnancy associated hypertension will be examined to determine if the condition is pre-­eclampsia requiring delivery before 37 weeks' gestation.
    Una vez entregados, los datos sobre el resultado del embarazo, incluyendo inicio del parto, edad gestacional al momento del parto, tipo de parto, el desarrollo de la hipertensión en el embarazo, el peso al nacer neonatal y de género, y otras complicaciones obstétricas, serán recogidos en los registros de maternidad de los hospitales o de su medicina general practicantes. Además, se examinaron los registros obstétricos de las mujeres con hipertensión asociada preexistente o de embarazo para determinar si la condición es la preeclampsia requiere un parto antes de 37 semanas de gestación.
    E.5.2Secondary end point(s)
    • Incidence of early-PE (<34 weeks) and total PE (at any gestation)

    • Neonatal birthweight below the 3rd, 5th and 10th centile

    • Stillbirth or neonatal death due to any cause

    • Stillbirth or neonatal death ascribed to PE or fetal growth restriction

    • Stillbirth or neonatal death in association with maternal or neonatal bleeding

    • Rate of neonatal intensive care unit admission

    • Composite measure of neonatal mortality and morbidity

    • Placental abruption (clinically or on placental examination)

    • Spontaneous preterm delivery <34 weeks and <37 weeks
    La incidencia de principios-PE (<34 semanas) y PE totales (en cualquier gestación)

    • Neonatal peso al nacer por debajo de la 3ª, 5ª y 10 percentil

    • La muerte fetal o muerte neonatal debido a cualquier causa

    • La muerte fetal o muerte neonatal atribuida a PE o restricción del crecimiento fetal

    • La muerte fetal o muerte neonatal en asociación con hemorragia materna o neonatal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once delivered, data on pregnancy outcome, including labour onset, gestational age at delivery, mode of delivery, development of hypertension in pregnancy, neonatal birth weight and gender, and other obstetrics complications, will be collected from the hospital maternity records or their general medical practitioners. In addition, the obstetric records of all women with pre­existing or pregnancy associated hypertension will be examined to determine if the condition is pre­eclampsia requiring delivery before 34 weeks' gestation.

    Neonatal outcomes will be collected from Special Care Baby Unit.
    Una vez entregados, los datos sobre el resultado del embarazo, incluyendo inicio del parto, edad gestacional al momento del parto, tipo de parto, el desarrollo de la hipertensión en el embarazo, el peso al nacer neonatal y de género, y otras complicaciones obstétricas, serán recogidos en los registros de maternidad de los hospitales o de su medicina general practicantes. Además, se examinaron los registros obstétricos de todas las mujeres con pre-existente o hipertensión asociada al embarazo para determinar si la condición es la preeclampsia requiere un parto antes de 34 semanas de gestación.

    Los resultados neonatales serán recogidos en la Unidad de Cuidados Especiales del bebé.
    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 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 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 EEA12
    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 end of the study for individual participants will be defined as 6 weeks after the birth of the baby/end of the pregnancy.



    The end of the study as a whole will be defined as the last visit of the last patient (n=2,000) with details of their complete pregnancy outcome. This will take approximately 18 months to complete.
    El final del estudio para los participantes individuales se define como 6 semanas después del nacimiento del bebé / final del embarazo.



    El final del estudio como un todo se define como la última visita del último paciente (n = 2.000) con los detalles de su resultado completa embarazo. Esto tomará aproximadamente 18 meses en completarse.
    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 days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2000
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state460
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2000
    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)
    Not appropriate as intervention is being studied only during pregnancy.
    No es apropiado que la intervención está siendo estudiado sólo durante el embarazo.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-12-20
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