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Clinical trials for Units of selection

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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    25 result(s) found for: Units of selection. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-004655-21 Sponsor Protocol Number: KRN-001 Start Date*: 2014-06-23
    Sponsor Name:Kern Pharma S.L.
    Full Title: New Dosing Systems in Paediatrics. Application to the individualization of the dose of fentanyl in neonatal patients.
    Medical condition: Analgesia, sedation.
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-004742-41 Sponsor Protocol Number: KRN-002 Start Date*: 2014-03-11
    Sponsor Name:Kern Pharma S.L.
    Full Title: New Dosing Systems in Paediatrics. Application to the individualization of the dose of fentanyl in patients between 1 month and 16 years of age.
    Medical condition: Analgesia, sedation.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004987-80 Sponsor Protocol Number: 2013-Colistin Start Date*: 2014-08-28
    Sponsor Name:CUB - Hôpital Erasme
    Full Title: Colistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance.
    Medical condition: Colistin use in Cystic Fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000020-32 Sponsor Protocol Number: CV131-176 Start Date*: 2005-02-16
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension
    Medical condition: Severe Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003408-21 Sponsor Protocol Number: THO-IM_02-CT Start Date*: 2015-12-09
    Sponsor Name:Thrombotargets Europe
    Full Title: A Phase II/III, randomized, controlled, single blind study to evaluate the haemostatic efficacy and safety of topically applied TT-173 in patients undergoing knee arthroplasty
    Medical condition: Haemostatic effect in patients undergoing knee arthroplasty
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10060663 Surgical hemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005367-10 Sponsor Protocol Number: CRAF265A2101 Start Date*: 2009-05-18
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase I/II, open-label, dose escalation trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of RAF265 (CHIR-265) administered orally to patients with locally advanced or metastat...
    Medical condition: local advanced or metastatic melanoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-003708-22 Sponsor Protocol Number: E2015-PK-USI-BMR-COLISTIN Start Date*: 2015-10-23
    Sponsor Name:Hospital Erasme
    Full Title: Colistin use in critically ill patients: pharmacokinetic population and pharmacodynamic studies, tolerance profil and risk of selection of resistance
    Medical condition: Patients in intensive care unit suffering of infection by multi-drug resistance bacteria treated by colistin
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10040054 Sepsis, bacteraemia, viraemia and fungaemia NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004666-15 Sponsor Protocol Number: TMC-MDC-11-01 Start Date*: 2012-04-03
    Sponsor Name:The Medicines Company
    Full Title: A Phase II, double-blind, parallel group, dose-selection study to compare antifibrinolytic MDCO-2010 vs. placebo and tranexamic acid in reducing blood loss in patients undergoing primary cardiac su...
    Medical condition: Primary cardiac surgery involving cardiopulmonary bypass
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001592-37 Sponsor Protocol Number: F02695_LP_2_05 Start Date*: 2012-10-16
    Sponsor Name:Pierre Fabre Médicament; Represented by Institut de Recherche Pierre Fabre
    Full Title: Effect of 3-month treatment with F2695 (75mg OD) on improving functional recovery of patients with ischemic stroke. A Multicenter, Randomised, Double-blind, Parallel-group, Placebo-Controlled Study.
    Medical condition: Functionnal impairment after acute ischemic stroke
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) CZ (Completed) PT (Completed) HU (Completed) BE (Completed) IT (Completed) FR (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2009-011818-21 Sponsor Protocol Number: UCL/09/0128 Start Date*: 2010-06-28
    Sponsor Name:University College London [...]
    1. University College London
    2.
    Full Title: Transplantation of umbilical cord blood from unrelated donors in patients with haematological diseases using a myeloablative conditioning regimen
    Medical condition: Haematological disorders
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004851 10018847 Haematological disorders HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-024273-38 Sponsor Protocol Number: UZ1 Start Date*: 2013-11-27
    Sponsor Name:University Hospitals Leuven
    Full Title: Supplemental corticosteroids in cirrhotic hypotensive patients with suspicion of sepsis
    Medical condition: Cirrhotic patients under vasopressors admitted to the ICU because of persisting hypotension and with suspected infection.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) CZ (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2013-000261-36 Sponsor Protocol Number: FGTW-1004 Start Date*: 2013-11-29
    Sponsor Name:LFB Biotechnologies
    Full Title: Clinical pharmacology, efficacy and safety study of FGTW in paediatric patients with severe congenital fibrinogen deficiency
    Medical condition: Afibrinogenaemia or severe hypofibrinogenaemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10052651 Afibrinogenaemia LLT
    16.1 10005329 - Blood and lymphatic system disorders 10051125 Hypofibrinogenaemia PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-000214-37 Sponsor Protocol Number: Wallstrength_01 Start Date*: 2007-08-07
    Sponsor Name:UMC St Radboud
    Full Title: Biological and biochemical markers of aneurysm wall degradation; towards non-invasive wall strength analysis.
    Medical condition: Abdominal aortic aneurysms. Biomarkers related to diminished aneurysm wall strength.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000051 Abdominal aneurysm LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000535-33 Sponsor Protocol Number: BCII_2015 Start Date*: 2015-12-01
    Sponsor Name:University Medical Center Groningen
    Full Title: Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resecti...
    Medical condition: Patients with breast cancer eligible for surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000192-37 Sponsor Protocol Number: 2019_0007 Start Date*: 2021-10-04
    Sponsor Name:Hôpital Foch
    Full Title: Oxidative Phosphorylation Targeting In Malignant glioma Using Metformin plus radiotherapy temozolomide
    Medical condition: Patients with a diagnosis of Glioblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002845-12 Sponsor Protocol Number: NEOCIRC-001 Start Date*: 2013-12-03
    Sponsor Name:SERMAS (Hospital la Paz)
    Full Title: An international multicentre open-label comparative therapeutic exploratory trial to investigate the role of a new neonatal formulation of dobutamine in the treatment of haemodynamic insufficiency ...
    Medical condition: babies with evidence of haemodynamic insufficiency within 72 hours after birth
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted) GB (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005833-34 Sponsor Protocol Number: AL-DES-01 Start Date*: 2021-09-06
    Sponsor Name:Ayala Pharmaceuticals, Inc.
    Full Title: RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumors
    Medical condition: Progressing desmoid tumors
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059352 Desmoid tumour PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Trial now transitioned) FR (Ongoing) PL (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001006-18 Sponsor Protocol Number: D5136C00007 Start Date*: 2014-08-27
    Sponsor Name:AstraZeneca AB
    Full Title: Multicenter, open-label, randomised, pharmacokinetic (PK) and pharmacodynamic (PD) dose-ranging Phase II study of ticagrelor followed by a double-blind, randomised, parallel-group, placebo-controll...
    Medical condition: Investigation of platelet aggregation in paediatric patients with sickle cell disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10040644 Sickle cell disease LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-002723-85 Sponsor Protocol Number: EPO-ANE-3018 Start Date*: 2009-02-11
    Sponsor Name:Janssen-Cilag International N.V
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Initiated at 40,000 IU Every Week or 80,000 IU Every Week Versus Placebo in Subjects With IPSS Low- or Inte...
    Medical condition: subjects with International Prognostic Scoring Systems (IPSS) Low or Intermediate 1 risk myelodysplastic syndromes (MDS) who require any transfusion, compared with placebo, through Week 48.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001772-28 Sponsor Protocol Number: PAC203 Start Date*: 2017-10-23
    Sponsor Name:CTI BioPharma Corp.
    Full Title: Phase 3 Study (PACIFICA): A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essent...
    Medical condition: Primary Myelofibrosis, Post-essential thrombocythemia myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/µL), Post polycythaemia vera myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077161 Primary myelofibrosis PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074692 Post essential thrombocythaemia myelofibrosis LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074691 Post polycythaemia vera myelofibrosis LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) SE (Completed) ES (Completed) FR (Completed) IT (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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