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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   44380   clinical trials with a EudraCT protocol, of which   7392   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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    7,392 result(s) found. Displaying page 338 of 370.
    «« First « Previous 334  335  336  337  338  339  340  341  342  Next» Last»»
    EudraCT Number: 2005-003518-14 Sponsor Protocol Number: SKY2028-3-003 Start Date*: 2006-01-25
    Sponsor Name:Skyepharma AG
    Full Title: Long-term Open-label Safety Study with SKP Flutiform HFA pMDI (100/10μg and 250/10μg) in Adult and Adolescent Patients with Asthma
    Medical condition: Mild to Moderate-Severe Asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000171-41 Sponsor Protocol Number: 0000726 Start Date*: Information not available in EudraCT
    Sponsor Name:Altus Pharmaceuticals Inc
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insuff...
    Medical condition: Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011766 Cystic fibrosis pancreatic LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Ongoing) IT (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-006276-11 Sponsor Protocol Number: VR496/005 Start Date*: 2008-09-01
    Sponsor Name:Vectura Limited
    Full Title: A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cys...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011763 Cystic fibrosis lung LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-007000-15 Sponsor Protocol Number: CICL670A2209 Start Date*: 2009-01-19
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in nontransfusion-dependent thalassemia patients with iron overload (THALASSA)
    Medical condition: Chronic iron overload in patients with non-transfusion-dependent thalassemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10043389 Thalassaemic disorders HLT
    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: 2009-016719-39 Sponsor Protocol Number: 050901 Start Date*: 2010-04-07
    Sponsor Name:Baxter Innovations GmbH
    Full Title: IMMUNINE – Purified Factor IX Concentrate Virus-Inactivated: A Phase IV, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors i...
    Medical condition: To expose up to 50 patients aged 12-64 years, and approximately 20 pediatric patients up to 11 years of age with severe or moderately severe hemophilia B to IMMUNINE for a period of approximately 2...
    Disease: Version SOC Term Classification Code Term Level
    15.0 10010331 - Congenital, familial and genetic disorders 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-012718-35 Sponsor Protocol Number: Loulla001 Start Date*: 2010-05-05
    Sponsor Name:Only For Children Pharmaceuticals
    Full Title: An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 ...
    Medical condition: Acute Lymphoblastic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Ongoing) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-012283-14 Sponsor Protocol Number: SECOND-LINE Start Date*: 2010-08-16
    Sponsor Name:National Centre in HIV Epidemiology and Clinical Research
    Full Title: A randomised open‐label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2‐3N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virological...
    Medical condition: Chronic HIV infection
    Disease: Version SOC Term Classification Code Term Level
    12.0 10008919 Chronic HIV infection LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed) FR (Ongoing) GB (Completed) DE (Ongoing)
    Trial results: (No results available)
    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
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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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