欧盟临床详情页-时间轴

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"attr_value":[ "No" ], "display_order":66 }, { "block_num":"E.", "eng_attr":"Randomised", "index_num":"E.8.1.1", "attr_value":[ "Yes" ], "display_order":140 }, { "block_num":"D.", "eng_attr":"Recombinant medicinal product", "index_num":"D.3.11.9", "attr_value":[ "No" ], "display_order":70 }, { "block_num":"N.", "eng_attr":"Review by the Competent Authority or Ethics Committee in the country concerned", "index_num":"N.", "attr_value":[ "-" ], "display_order":201 }, { "block_num":"D.", "eng_attr":"Route of administration of the placebo", "index_num":"D.8.4", "attr_value":[ "Oral use" ], "display_order":79 }, { "block_num":"D.", "eng_attr":"Routes of administration for this IMP", "index_num":"D.3.7", "attr_value":[ "Oral use" ], "display_order":46 }, { "block_num":"E.", "eng_attr":"Safety", "index_num":"E.6.4", "attr_value":[ "Yes" ], "display_order":119 }, { "block_num":"E.", "eng_attr":"Scope of the trial", "index_num":"E.6 and E.7", "attr_value":[ "-" ], "display_order":114 }, { "block_num":"E.", "eng_attr":"Scope of the Trial", "index_num":"E.6", "attr_value":[ "-" ], "display_order":115 }, { "block_num":"E.", "eng_attr":"Secondary end point(s)", "index_num":"E.5.2", "attr_value":[ "-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)." ], "display_order":110 }, { "block_num":"E.", "eng_attr":"Secondary end point(s) (es)", "index_num":"E.5.2", "attr_value":[ "-\u00cdndice de pulsatilidad medio de las arterias uterinas a las 28 semanas ", "-Preeclampsia: tensi\u00f3n arterial diast\u00f3lica (TAD) >=90 mmHg) y o sist\u00f3lica (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), cl\u00ednica neurol\u00f3gica (cerebrales o visuales), edema agudo de pulm\u00f3n (criterio radiol\u00f3gico y gasom\u00e9trico), dolor epig\u00e1strico persistente, alteraci\u00f3n de la funci\u00f3n hep\u00e1tica (AST o ALT > 70 UI), signos anal\u00edticos de hem\u00f3lisis (LDH>700 U/L) y/o trombocitopenia (<100.000/ml). ", "-Edad gestacional al parto (parto prematuro: antes de las 34 semanas de gestaci\u00f3n). ", "-Retraso de crecimiento intrauterino: peso neonatal inferior al percentil 10 de nuestra poblaci\u00f3n + \u00edndice de pulsatilidad en la arteria umbilical durante el tercer trimestre (en dos ocasiones separadas > 48h) superior al percentil 95. ", "-Cesarea urgente por p\u00e9rdida de bienestar fetal. ", "-Peso neonatal ", "-Acidosis neonatal (pH arterial <7.10 + EB > 12 mEq/L) ", "-Mortalidad perinatal (>22 semanas de gestaci\u00f3n-<28 d\u00edas posparto) ", "-D\u00edas estancia en la Unidad de Cuidados Intensivos Neonatales ", "-Morbilidad neonatal significativa (convulsiones, hemorragia intraventricular > grado III, leucomalacia periventricular, encefalopat\u00eda hip\u00f3xico-isqu\u00e9mica, electroencefalograma anormal, enterocolitis necrotizante, fallo renal agudo (creatinina s\u00e9rica >1,5 mg/dl) o fallo cardiaco (requiriendo agentes inotr\u00f3picos)" ], "display_order":111 }, { "block_num":"E.", "eng_attr":"Secondary objectives of the trial", "index_num":"E.2.2", "attr_value":[ "-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." ], "display_order":98 }, { "block_num":"E.", "eng_attr":"Secondary objectives of the trial (es)", "index_num":"E.2.2", "attr_value":[ "-Demostrar que el tratamiento con acido acetilsalic\u00edlico a bajas dosis en gestantes de riesgo por doppler patol\u00f3gico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de preclampsia. ", "-Demostrar que el tratamiento con acido acetilsalic\u00edlico a bajas dosis en gestantes de riesgo por doppler patol\u00f3gico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de retraso de crecimiento intrauterino. ", "-Demostrar que el tratamiento con acido acetilsalic\u00edlico a bajas dosis en gestantes de riesgo por doppler patol\u00f3gico de las arterias uterinas en el primer trimestre resulta en una menor incidencia de partos por debajo de las 34 semanas" ], "display_order":99 }, { "block_num":"E.", "eng_attr":"Single blind", "index_num":"E.8.1.3", "attr_value":[ "No" ], "display_order":142 }, { "block_num":"D.", "eng_attr":"Somatic cell therapy medicinal product", "index_num":"D.3.11.3.1", "attr_value":[ "No" ], "display_order":60 }, { "block_num":"B.", "eng_attr":"Source(s) of Monetary or Material Support for the clinical trial", "index_num":"B.4", "attr_value":[ "-" ], "display_order":17 }, { "block_num":"D.", "eng_attr":"Specific paediatric formulation", "index_num":"D.3.4.1", "attr_value":[ "No" ], "display_order":45 }, { "block_num":"F.", "eng_attr":"Specific vulnerable populations", "index_num":"F.3.3", "attr_value":[ "Yes" ], "display_order":187 }, { "block_num":"B.", "eng_attr":"Sponsor", "index_num":"B.", "attr_value":[ "1" ], "display_order":13 }, { "block_num":"B.", "eng_attr":"Sponsor Information", "index_num":"B.", "attr_value":[ "-" ], "display_order":12 }, { "block_num":"A.", "eng_attr":"Sponsor's protocol code number", "index_num":"A.4.1", "attr_value":[ "ASAP" ], "display_order":9 }, { "block_num":"D.", "eng_attr":"Status of the IMP to be used in the clinical trial", "index_num":"D.2", "attr_value":[ "-" ], "display_order":34 }, { "block_num":"B.", "eng_attr":"Status of the sponsor", "index_num":"B.3.1 and B.3.2", "attr_value":[ "Non-Commercial" ], "display_order":16 }, { "block_num":"B.", "eng_attr":"Street Address", "index_num":"B.5.3.1", "attr_value":[ "Villarroel 170" ], "display_order":24 }, { "block_num":"D.", "eng_attr":"Strength", "index_num":"D.3.10", "attr_value":[ "-" ], "display_order":52 }, { "block_num":"F.", "eng_attr":"Subjects incapable of giving consent personally", "index_num":"F.3.3.6", "attr_value":[ "No" ], "display_order":193 }, { "block_num":"E.", "eng_attr":"System Organ Class", "index_num":"E.1.2", "attr_value":[ "10036585 - Pregnancy, puerperium and perinatal conditions" ], "display_order":93 }, { "block_num":"B.", "eng_attr":"Telephone number", "index_num":"B.5.4", "attr_value":[ "+349322754003343" ], "display_order":28 }, { "block_num":"E.", "eng_attr":"Term", "index_num":"E.1.2", "attr_value":[ "Placental insufficiency" ], "display_order":92 }, { "block_num":"D.", "eng_attr":"The IMP contains an", "index_num":"D.3.11", "attr_value":[ "-" ], "display_order":56 }, { "block_num":"D.", "eng_attr":"The IMP has been designated in this indication as an orphan drug in the Community", "index_num":"D.2.5", "attr_value":[ "No" ], "display_order":39 }, { "block_num":"E.", "eng_attr":"The trial involves multiple Member States", "index_num":"E.8.5", "attr_value":[ "No" ], "display_order":155 }, { "block_num":"E.", "eng_attr":"The trial involves multiple sites in the Member State concerned", "index_num":"E.8.4", "attr_value":[ "Yes" ], "display_order":153 }, { "block_num":"E.", "eng_attr":"The trial involves single site in the Member State concerned", "index_num":"E.8.3", "attr_value":[ "No" ], "display_order":152 }, { "block_num":"E.", "eng_attr":"Therapeutic area", "index_num":"E.1.1.2", "attr_value":[ "Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]" ], "display_order":86 }, { "block_num":"E.", "eng_attr":"Therapeutic confirmatory (Phase III)", "index_num":"E.7.3", "attr_value":[ "No" ], "display_order":136 }, { "block_num":"E.", "eng_attr":"Therapeutic exploratory (Phase II)", "index_num":"E.7.2", "attr_value":[ "Yes" ], "display_order":135 }, { "block_num":"E.", "eng_attr":"Therapeutic use (Phase IV)", "index_num":"E.7.4", "attr_value":[ "No" ], "display_order":137 }, { "block_num":"E.", "eng_attr":"Therapy", "index_num":"E.6.3", "attr_value":[ "No" ], "display_order":118 }, { "block_num":"E.", "eng_attr":"Timepoint(s) of evaluation of this end point", "index_num":"E.5.1.1", "attr_value":[ "Delivery" ], "display_order":108 }, { "block_num":"E.", "eng_attr":"Timepoint(s) of evaluation of this end point", "index_num":"E.5.2.1", "attr_value":[ "Delivery" ], "display_order":112 }, { "block_num":"E.", "eng_attr":"Timepoint(s) of evaluation of this end point (es)", "index_num":"E.5.1.1", "attr_value":[ "Parto" ], "display_order":109 }, { "block_num":"E.", "eng_attr":"Timepoint(s) of evaluation of this end point (es)", "index_num":"E.5.2.1", "attr_value":[ "Parto" ], "display_order":113 }, { "block_num":"D.", "eng_attr":"Tissue Engineered Product", "index_num":"D.3.11.3.3", "attr_value":[ "No" ], "display_order":62 }, { "block_num":"A.", "eng_attr":"Title of the trial for lay people, in easily understood, i.e. non-technical, language", "index_num":"A.3.1", "attr_value":[ "Use of Aspirin to improve the transport of blood to the fetus in patients with altered Doppler US" ], "display_order":6 }, { "block_num":"A.", "eng_attr":"Title of the trial for lay people, in easily understood, i.e. non-technical, language (es)", "index_num":"A.3.1", "attr_value":[ "Utilizaci\u00f3n del \u00e1cido acetilsalic\u00edlico para la mejora del transporte de la sangre al feto en pacientes que presentan ecograf\u00edas Doppler alteradas" ], "display_order":7 }, { "block_num":"B.", "eng_attr":"Town/ city", "index_num":"B.5.3.2", "attr_value":[ "Barcelona" ], "display_order":25 }, { "block_num":"D.", "eng_attr":"Trade name", "index_num":"D.2.1.1.1", "attr_value":[ "Tromatyl 150 mg prolonged-release hard capsules" ], "display_order":36 }, { "block_num":"E.", "eng_attr":"Trial being conducted both within and outside the EEA", "index_num":"E.8.6.1", "attr_value":[ "No" ], "display_order":157 }, { "block_num":"E.", "eng_attr":"Trial being conducted completely outside of the EEA", "index_num":"E.8.6.2", "attr_value":[ "No" ], "display_order":158 }, { "block_num":"E.", "eng_attr":"Trial contains a sub-study", "index_num":"E.2.3", "attr_value":[ "No" ], "display_order":100 }, { "block_num":"E.", "eng_attr":"Trial has a data monitoring committee", "index_num":"E.8.7", "attr_value":[ "No" ], "display_order":159 }, { "block_num":"F.", "eng_attr":"Trial has subjects under 18", "index_num":"F.1.1", "attr_value":[ "No" ], "display_order":171 }, { "block_num":"E.", "eng_attr":"Trial involving sites outside the EEA", "index_num":"E.8.6", "attr_value":[ "-" ], "display_order":156 }, { "block_num":"A.", "eng_attr":"Trial is part of a Paediatric Investigation Plan", "index_num":"A.7", "attr_value":[ "No" ], "display_order":10 }, { "block_num":"E.", "eng_attr":"Trial type and phase", "index_num":"E.7", "attr_value":[ "-" ], "display_order":129 }, { "block_num":"E.", "eng_attr":"Version", "index_num":"E.1.2", "attr_value":[ "14.1" ], "display_order":89 }, { "block_num":"F.", "eng_attr":"Women of child-bearing potential using contraception", "index_num":"F.3.3.2", "attr_value":[ "No" ], "display_order":189 }, { "block_num":"F.", "eng_attr":"Women of childbearing potential not using contraception", "index_num":"F.3.3.1", "attr_value":[ "No" ], "display_order":188 } ], "count_info":208 }

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