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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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    4,450 result(s) found. Displaying page 184 of 223.
    «« First « Previous 180  181  182  183  184  185  186  187  188  Next» Last»»
    EudraCT Number: 2008-005855-61 Sponsor Protocol Number: 1100.1518 Start Date*: 2009-05-20
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: An open-label, multiple dose, cross-over study to evaluate the steady-state pharmacokinetic parameters of nevirapine extended release tablets in HIV-1 infected children, with an optional extension ...
    Medical condition: HIV-1 infected children under antiretroviral therapy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-022872-30 Sponsor Protocol Number: PALO-10-20 Start Date*: 2011-08-04
    Sponsor Name:Helsinn Healthcare SA
    Full Title: A multicenter, randomized, double-blind, parallel group study to evaluate the efficacy and safety of two different doses of palonosetron compared to ondansetron in the prevention of CINV in pediatr...
    Medical condition: Study to evaluate the efficacy and safety of two different doses of palonosetron compared to ondansetron in the prevention of CINV in pediatric patients undergoing single and repeated cycles of MEC...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10042613 - Surgical and medical procedures 10049091 Chemotherapy antiemetic prophylaxis LLT
    13.1 10042613 - Surgical and medical procedures 10036899 Prophylaxis against chemotherapy induced vomiting LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) AT (Completed) BG (Completed) EE (Completed) DE (Completed) FR (Ongoing) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-003401-26 Sponsor Protocol Number: 400-12-006 Start Date*: 2014-05-16
    Sponsor Name:Ethicon Inc.
    Full Title: A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery in Pediatric P...
    Medical condition: Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018730-51 Sponsor Protocol Number: 113977 Start Date*: 2010-11-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open, multi-centre, controlled study to assess the long-term persistence of antibodies after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY tetanus-t...
    Medical condition: Vaccination of children 2 to 10 years of age against invasive disease caused by meningococcal serogroups A, C, W-135, and Y.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10027274 Meningococcal infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-018168-81 Sponsor Protocol Number: EMR-700773-503 Start Date*: 2010-04-16
    Sponsor Name:Merck Serono Norway
    Full Title: ENDURE: A Phase IV, prospective, open-label, uncontrolled, multi-centre cohort trial to assess the responsiveness of subjects with phenylketonuria (PKU) to treatment with Kuvan® 20 mg/kg/day for 28...
    Medical condition: Subjects diagnosed with Phenylketonuria (PKU) (classic or mild PKU, or mild hyperphenylalaninaemia (HPA)).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10034873 Phenylketonuria (PKU) LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) NO (Ongoing)
    Trial results: View results
    EudraCT Number: 2009-015817-31 Sponsor Protocol Number: OC3-DB-02 Start Date*: 2009-12-01
    Sponsor Name:OxThera IP AB
    Full Title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary Hyperoxaluria
    Medical condition: primary hyperoxaluria
    Disease: Version SOC Term Classification Code Term Level
    12.0 10020703 Hyperoxaluria LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-010108-27 Sponsor Protocol Number: P05574 Start Date*: 2012-10-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and B...
    Medical condition: Children 5 to 11 years of age with persistent asthma.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006220-19 Sponsor Protocol Number: SUM-2006/01-INT Start Date*: 2008-11-27
    Sponsor Name:PLIVA Hrvatska d.o.o.
    Full Title: Safety and Efficacy of Sumamed® Therapy in the Treatment of Respiratory Tract Infections in Adults and Children: International, Multicenter, Non-Comparative Study
    Medical condition: acute pharyngitis/tonsilitis acute sinusitis acute otitis media acute exacerbation of chronic bronchitis community acquired pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001002 Acute pharyngitis LLT
    9.1 10001093 Acute tonsillitis LLT
    9.1 10001076 Acute sinusitis LLT
    9.1 10033079 Otitis media acute LLT
    9.1 10000743 Acute exacerbation of chronic bronchitis LLT
    9.1 10010120 Community acquired pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed) CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-003359-19 Sponsor Protocol Number: GALPED1001 Start Date*: 2007-08-07
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome
    Medical condition: Children with Down syndrom
    Disease: Version SOC Term Classification Code Term Level
    8.1 10013616 Down's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004088-22 Sponsor Protocol Number: BI 3023_3001 Start Date*: 2009-09-22
    Sponsor Name:CSL BEHRING GmbH
    Full Title: Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency
    Medical condition: Congenital fibrinogen deficiency ( afibrinogenemia, severe hypofibrinogenemia)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016075 LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000164-10 Sponsor Protocol Number: SPD476-112 Start Date*: 2013-01-04
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2016-000622-19 Sponsor Protocol Number: TV50717-CNS-30046 Start Date*: 2018-08-01
    Sponsor Name:Teva Branded Pharmaceutical Products R&D, Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
    Medical condition: Tics associated with Tourette Syndrome(TS)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-000468-83 Sponsor Protocol Number: 31-10-273 Start Date*: 2011-12-15
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder
    Medical condition: Tourette’s Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10044126 Tourette's disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-012584-34 Sponsor Protocol Number: GRASPALL2009-06 Start Date*: 2010-01-06
    Sponsor Name:ERYTECH Pharma
    Full Title: A multicentre, open, randomized, Phase II/III study, evaluating efficacy and safety of erythrocytes encapsulating L-Asparaginase (GRASPA®) versus reference L-asparaginase treatment in combination w...
    Medical condition: Acute Lymphoblastic Leukaemia
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002880-42 Sponsor Protocol Number: LAL-CL05 Start Date*: 2011-12-05
    Sponsor Name:Synageva Biopharma Corp.
    Full Title: An Open Label Multicenter Extension Study to Evaluate the Long-Term Efficacy and Safety of SBC 102 in Children with Lysosomal Acid Lipase Deficiency Who Previously Received Treatment with SBC-102
    Medical condition: Growth failure in children due to lysosomal acid lipase deficiency (Wolman disease).
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10027433 Metabolism and nutrition disorders SOC
    14.0 10027433 - Metabolism and nutrition disorders 10021605 Inborn errors of metabolism HLGT
    14.0 10010331 - Congenital, familial and genetic disorders 10024579 Lysosomal storage disorders HLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-002602-20 Sponsor Protocol Number: V104P2 Start Date*: 2008-09-30
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine with...
    Medical condition: seasonal influenza
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022000 Influenza LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-000844-15 Sponsor Protocol Number: A6111139 Start Date*: 2008-10-29
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, NEW YORK, NY 10017. US
    Full Title: A PHASE 1, OPEN-LABEL STUDY OF LATANOPROST ACID PLASMA CONCENTRATIONS IN PEDIATRIC AND ADULT GLAUCOMA PATIENTS TREATED WITH LATANOPROST 0.005%
    Medical condition: GLAUCOMA
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018304 Glaucoma LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) PT (Completed) DK (Completed) PL (Ongoing) IT (Completed) GR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002080-26 Sponsor Protocol Number: V58P15 Start Date*: 2013-08-28
    Sponsor Name:Novartis Vaccines & Diagnostics AG
    Full Title: A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (tivc) or in Embryonated Eggs (TI...
    Medical condition: volunteers at high risk for influenza-related complications (protection against influenza)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10016794 Flu vaccination LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-001152-35 Sponsor Protocol Number: UX003-CL201 Start Date*: 2013-08-02
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: An Open-Label Phase 1/2 Study to Assess the Safety, Efficacy and Dose of UX003 rhGUS Enzyme Replacement Therapy in Patients with MPS 7
    Medical condition: Mucopolysaccharidosis type 7 (MPS 7, Sly syndrome)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-002528-41 Sponsor Protocol Number: BPT05-641 Start Date*: 2006-09-04
    Sponsor Name:Interdos Pharma bv
    Full Title: A comparison of the clinical efficacies of Fusidic acid hydrophilic cream 20 mg/g and Fucidin in the treatment of adult and paediatric patients with impetigo
    Medical condition: Impetigo
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (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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