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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-000622-22
    Sponsor's Protocol Code Number:ASAP
    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:2012-05-10
    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 number2012-000622-22
    A.3Full title of the trial
    Aspirin for the enhancement of trophoblastic invasion in women with abnormal uterine artery Doppler at 11-14 weeks of gestation
    Acido acetilsalicílico para la mejora de la invasión trofoblástica en gestantes con doppler patológico de las uterinas a las 11-14 semanas de gestación
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of Aspirin to improve the transport of blood to the fetus in patients with altered Doppler US
    Utilización del ácido acetilsalicílico para la mejora del transporte de la sangre al feto en pacientes que presentan ecografías Doppler alteradas
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberASAP
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    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 supportMSPS Ministerio de Sanidad y Política Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Clinic per a la Recerca Biomèdica
    B.5.2Functional name of contact pointCTU Clinic-Farmacología clinica
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754003343
    B.5.5Fax number+34932279877
    B.5.6E-mailsvarea@clinic.ub.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 Tromatyl 150 mg prolonged-release hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderRottapharm SL
    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 nameTromatyl 150 mg prolonged-release hard capsules
    D.3.2Product code NA
    D.3.4Pharmaceutical form Capsule, hard
    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 typeequal
    D.3.10.3Concentration number150
    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, hard
    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
    Placental insufficiency
    Insuficiencia placentaria
    E.1.1.1Medical condition in easily understood language
    Placental Insufficiency
    insuficiencia placentaria
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10035138
    E.1.2Term Placental insufficiency
    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 establish wether a prophylactic intervention from first trimestre with low-dose of aspirine improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester.
    Demostrar que el tratamiento con ácido acetilsalicilico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una reducción de la resistencia de la circulación placentaria en tercer trimestre
    E.2.2Secondary objectives of the trial
    -To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence or preeclampsia in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester.

    -To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence of intrauterine growth retardation in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester.

    -To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence of births below 34 weeks in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester.
    -Demostrar que el tratamiento con acido acetilsalicílico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de preclampsia.

    -Demostrar que el tratamiento con acido acetilsalicílico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de retraso de crecimiento intrauterino.

    -Demostrar que el tratamiento con acido acetilsalicílico a bajas dosis en gestantes de riesgo por doppler patológico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de partos por debajo de las 34 semanas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length: 45-48 mm)

    -Single gestation

    -Mean pulsatility index of the uterine arteries above the 95th percentile for our population
    -Pacientes mayores de 18 años que acudan para ecografía de rutina de primer trimestre de la gestación entre las 11 y las 14 semanas de gestación (longitud cráneo caudal 45-48 mm)

    -Gestaciones únicas

    -Índice de pulsatilidad medio de las arterias uterinas por encima del percentil 95 para nuestra población
    E.4Principal exclusion criteria
    -Pre-existing hypertension, renal or cardiovascular disease
    - previous history of preeclampsia
    -Pregestational diabetes

    -Systemic Lupus Erythematosus

    -Gastric ulcer

    -Acetylsalicylic acid or lactose Hypersensitivity

    -Bleeding disorders

    Fetal malformations (including chromosomal abnormalities)

    -Administration of low molecular weight heparin
    - concomitant treatment with aspirine
    - Enfermedad preexistente hipertensiva, renal o cardiovascular
    -Antecedentes de preeclampsia

    -Diabetes pregestacional

    -Lupus eritemasoso sistémico

    -Úlcera gástrica

    -Hipersensibilidad al ácido acetilsalicílico o la lactosa

    -Enfermedades hemorrágicas

    -Malformaciones fetales (incluidas cromosomopatías)

    -Administración de heparina de bajo peso molecular
    - tratamiento concomitante con aspirina
    E.5 End points
    E.5.1Primary end point(s)
    -Uterine artery mean pulsatility index at 28 weeks.
    -Índice de pulsatilidad medio de las arterias uterinas a las 28 semanas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Delivery
    Parto
    E.5.2Secondary end point(s)
    -Uterine artery pulsatility index at 28 weeks.

    -Pre-eclampsia: diastolic blood pressure (DBP)> = 90 mmHg) or systolic (SBP)> = 140 mmHg on two separated determinations (> 4h) with proteinuria> 300 mg/24 h

    -Gestational age at debut of preeclampsia

    -Severe preeclampsia: preeclampsia criteria + DBP> = 110 mmHg, proteinuria> 5g/24h, oligouria (<400 ml/24h), neurological symptoms (brain or visual), acute pulmonary edema (gasometric and radiological criteria), persistent epigastric pain, abnormal liver function (AST or ALT> 70 IU), analytical signs of hemolysis (LDH> 700 U / L) and / or thrombocytopenia (<100.000/ml).

    -Gestational age at delivery (preterm birth: before 34 weeks gestation)

    -Intrauterine Growth Retardation: birth weight below the 10th percentile of our population + pulsatility index in umbilical artery in the third trimester (on two separate occasions >48h) above the 95th percentile.

    -Emergent cesarean section due to fetal wellbeing loss

    -Birth weight

    -Neonatal acidosis (arterial pH <7.10 + EB> 12 mEq / L)

    -Perinatal mortality (> 22 weeks gestation, <28 days postpartum)

    -Days in the Neonatal Intensive Care Unit

    -Significant neonatal morbidity (convulsions, intraventricular hemorrhage> grade III, periventricular leukomalacia, hypoxic-ischemic encephalopathy, abnormal electroencephalogram, necrotizing enterocolitis, acute renal failure (serum creatinine> 1.5 mg / dl) or heart failure (requiring inotropic agents).
    -Índice de pulsatilidad medio de las arterias uterinas a las 28 semanas

    -Preeclampsia: tensión arterial diastólica (TAD) >=90 mmHg) y o sistólica (TAS) > = 140 mmHg en dos determinaciones separadas > 4h + proteinuria > 300 mg/24h.

    -Edad gestacional debut de la preeclampsia

    -Preeclampsia grave: criterios de preeclampsia + TAD > = 110 mmHg , proteinuria > 5g/24h, oligouria (<400 ml/24h), clínica neurológica (cerebrales o visuales), edema agudo de pulmón (criterio radiológico y gasométrico), dolor epigástrico persistente, alteración de la función hepática (AST o ALT > 70 UI), signos analíticos de hemólisis (LDH>700 U/L) y/o trombocitopenia (<100.000/ml).

    -Edad gestacional al parto (parto prematuro: antes de las 34 semanas de gestación).

    -Retraso de crecimiento intrauterino: peso neonatal inferior al percentil 10 de nuestra población + índice de pulsatilidad en la arteria umbilical durante el tercer trimestre (en dos ocasiones separadas > 48h) superior al percentil 95.

    -Cesarea urgente por pérdida de bienestar fetal.

    -Peso neonatal

    -Acidosis neonatal (pH arterial <7.10 + EB > 12 mEq/L)

    -Mortalidad perinatal (>22 semanas de gestación-<28 días posparto)

    -Días estancia en la Unidad de Cuidados Intensivos Neonatales

    -Morbilidad neonatal significativa (convulsiones, hemorragia intraventricular > grado III, leucomalacia periventricular, encefalopatía hipóxico-isquémica, electroencefalograma anormal, enterocolitis necrotizante, fallo renal agudo (creatinina sérica >1,5 mg/dl) o fallo cardiaco (requiriendo agentes inotrópicos)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Delivery
    Parto
    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 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned3
    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 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
    Last visit of the last subject (LVLS)
    Última visita al último paciente.
    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 months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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 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: 270
    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 state270
    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)
    NA
    N/A
    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 Decision2012-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
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