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Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44358   clinical trials with a EudraCT protocol, of which   7384   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7,384 result(s) found. Displaying page 338 of 370.
    «« First « Previous 334  335  336  337  338  339  340  341  342  Next» Last»»
    EudraCT Number: 2010-020061-24 Sponsor Protocol Number: CACZ885D2203 Start Date*: 2010-08-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, multicenter, efficacy and safety study of 4-month canakinumab treatment with 5-month follow-up and long-term treatment period in patients with active recurrent or chronic TNF-recepto...
    Medical condition: TNF-receptor associated periodic syndrome (TRAPS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10067783 Tumor necrosis factor receptor-associated periodic syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019775-29 Sponsor Protocol Number: V114-003 Start Date*: 2010-09-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: "Estudio multicéntrico y doble ciego de la seguridad, la tolerabilidad y la inmunogenicidad de una vacuna antineumocócica conjugada (V114) en comparación con Prevenar 13™ en lactantes sanos";"A Mul...
    Medical condition: Prevención de la enfermedad invasiva neumocócica, la neumonía neumocócica y la otitis media causada por S. pneumoniae, debido a los serotipos capsulares incluidos en la vacuna (4, 6B,9V,14,18C,19F,...
    Disease: Version SOC Term Classification Code Term Level
    13 10054047 Sepsis neumocócica LLT
    13 10058886 Bacteriemia por neumococo LLT
    13 10027253 Meningitis neumocócica LLT
    13 10035647 Neumonía neumocócica LLT
    13 10033078 Otitis media LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) FI (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019348-37 Sponsor Protocol Number: CLDE225X2104 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase 1 study of LDE225 in pediatric patients with recurrent or refractory medulloblastoma or other tumors potentially dependent on the Hedgehog-signaling pathway
    Medical condition: pediatric patients with recurrent or refractory medulloblastoma or other tumors potentially dependent on the Hedgehog-signaling pathway (rhabdomyosarcoma, neuroblastoma, hepatoblastoma, high-grade ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10066594 Medulloblastoma recurrent LLT
    12.1 10039027 Rhabdomyosarcoma recurrent LLT
    12.1 10066595 Neuroblastoma recurrent LLT
    12.1 10065443 Malignant glioma LLT
    12.1 10031296 Osteosarcoma recurrent LLT
    12.1 10019823 Hepatoblastoma recurrent LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016361-28 Sponsor Protocol Number: AI424397 Start Date*: 2011-01-26
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with an O...
    Medical condition: HIV, PEDIATRIC
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) IT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021062-29 Sponsor Protocol Number: CICL670A2214 Start Date*: 2010-12-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe c...
    Medical condition: transfusion-dependent patients with TM, DBA or congenital sideroblastic anemia with severe cardiac iron overload
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10065974 Chronic iron overload LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2010-018911-13 Sponsor Protocol Number: 31-09-267 Start Date*: 2011-06-14
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia...
    Medical condition: Schizophrenia in Adolescent Patients or Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    14.1 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) BG (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004074-28 Sponsor Protocol Number: UKHEP001 Start Date*: 2012-07-20
    Sponsor Name:Promethera Biosciences
    Full Title: A prospective, open label, multicenter, randomized, safety and preliminary efficacy study of one cycle of Promethera HepaStem® in Urea Cycle Disorders and Crigler-Najjar Syndrome patients
    Medical condition: Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The ur...
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10021601 Inborn error of metabolism NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000845-11 Sponsor Protocol Number: TIRCON2012V1 Start Date*: 2012-07-16
    Sponsor Name:ApoPharma Inc.
    Full Title: A randomized, double-blind, placebo-controlled trial of deferiprone in patients with pantothenate kinase-associated neurodegeneration (PKAN)
    Medical condition: Pantothenate kinase-associated neurodegeneration (PKAN)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-001331-22 Sponsor Protocol Number: CCD-1011-PR-0059 Start Date*: 2012-05-07
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A FIRST IN HUMAN CLINICAL STUDY ON THE SAFETY AND TOLERABILITY OF TWO ESCALATING SINGLE DOSES OF CHF 5633 (SYNTHETIC SURFACTANT) IN PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
    Medical condition: preterm neonates with Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    16.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    16.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-005047-40 Sponsor Protocol Number: SIT001-12 Start Date*: 2015-03-25
    Sponsor Name:Sanofi-Aventis AG
    Full Title: A Randomized, Double Blind, Single Dose, Crossover Study, in Subjects with Mild to Moderate Asthma, to Compare the Pharmacodynamic (Bronchodilator) Responses of 12.5/250 µg and 50/250 µg Salmeterol...
    Medical condition: Mild to moderate asthma
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004855 10003565 Asthmatic LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-004787-37 Sponsor Protocol Number: VX14-661-107 Start Date*: 2015-09-21
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cy...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-001516-30 Sponsor Protocol Number: GDX-44-007 Start Date*: Information not available in EudraCT
    Sponsor Name:GUERBET
    Full Title: Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, gadopiclenol, in pediatric patients from 2 to 17 years of ageundergoing contrast-enhanced MRI.
    Medical condition: Pediatric subjects from 2 to 17 years old scheduled to undergo routine gadolinium contrast enhanced Magnetic Resonance Imaging of Central Nervous System
    Disease: Version SOC Term Classification Code Term Level
    21.1 10022891 - Investigations 10029817 Nuclear magnetic resonance imaging brain PT
    21.1 10022891 - Investigations 10072232 Nuclear magnetic resonance imaging spinal PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Ongoing) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2018-003790-10 Sponsor Protocol Number: MEQ00065 Start Date*: 2019-05-28
    Sponsor Name:Sanofi Pasteur
    Full Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age
    Medical condition: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2008-005354-20 Sponsor Protocol Number: 12710A Start Date*: 2016-03-15
    Sponsor Name:H. Lundbeck A/S
    Full Title: Interventional, randomised, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years, with Major depressive disor...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    19.1 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) EE (Completed) GB (Completed) HU (Completed) BG (Completed) DE (Completed) FI (Not Authorised) IT (Completed) ES (Completed) BE (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-016841-24 Sponsor Protocol Number: 113369 Start Date*: 2010-05-13
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: Estudio de fase IIIB, abierto, multinacional, aleatorizado y controlado para demostrar la no inferioridad de la respuesta inmunitaria a la vacuna antimeningocócica (serogrupos A, C, W-135 e Y) conj...
    Medical condition: Inmunización activa de lactantes frente a los serogrupos A, C, W-135 e Y de Neisseria meningitidis durante el primer año de vida, seguida de una dosis de recuerdo administrada a los 12 meses de edad.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10062371 Active immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2011-002008-33 Sponsor Protocol Number: A6181196 Start Date*: 2012-02-21
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR
    Medical condition: Pediatric Gastro Intestinal Stromal Tumor (GIST)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10062427 Gastrointestinal stromal tumor LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) Outside EU/EEA CZ (Completed) PT (Completed) IT (Completed) GB (Completed) PL (Completed) AT (Completed) DE (Completed) FR (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2006-003762-33 Sponsor Protocol Number: 106481 Start Date*: 2006-12-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, double blind, randomised, placebo–controlled, multi–country, multicentre study to assess the safety, reactogenicity and immunogenicity of two doses of GlaxoSmithKline (GSK) Biological...
    Medical condition: Primary immunisation of pre–term infants against human rotavirus gastroenteritis (GE)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-003807-38 Sponsor Protocol Number: 108464 Start Date*: 2007-01-30
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine co-administered with GlaxoSmithKline Biological...
    Medical condition: In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical ...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-002099-40 Sponsor Protocol Number: 308962 Start Date*: 2005-01-20
    Sponsor Name:Schering AG
    Full Title: Double-blind, randomized, reference-controlled, multicenter, parallel-group study to compare the efficacy and safety of Advantan ointment once daily with Protopic 0.03% ointment twice daily over ma...
    Medical condition: Atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    7.1 10012438 PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-002673-22 Sponsor Protocol Number: 309189 Start Date*: 2005-03-11
    Sponsor Name:Schering AG
    Full Title: Double-blind, placebo controlled, randomized, multicenter, parallel-group study to compare the efficacy and safety of Advantan cream twice weekly with Advabas cream during a maintenance phase of 16...
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    7.1 10012438 PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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