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Clinical trials for Safety

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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    27,966 result(s) found for: Safety. Displaying page 1 of 1,399.
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    EudraCT Number: 2015-004445-10 Sponsor Protocol Number: CVAL489K1101 Start Date*: 2016-06-07
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age.
    Medical condition: Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003855-76 Sponsor Protocol Number: GA29145 Start Date*: 2015-08-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144
    Medical condition: Crohn`s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) EE (Prematurely Ended) LT (Prematurely Ended) LV (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) SK (Prematurely Ended) CZ (Prematurely Ended) BE (Prematurely Ended) AT (Completed) FR (Ongoing) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001172-41 Sponsor Protocol Number: ITI-007-503 Start Date*: 2022-01-13
    Sponsor Name:Intra-Cellular Therapies, Inc.
    Full Title: An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10025458 Major depressive disorder, recurrent episode, moderate degree LLT
    21.1 100000004873 10081270 Major depressive disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed) HU (Completed) BG (Completed) PL (Completed) SE (Completed) FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-004442-25 Sponsor Protocol Number: CFAM810B2304 Start Date*: 2016-04-12
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A multicenter, open-label, single-arm, two-step study to evaluate the safety and single-dose pharmacokinetics of famciclovir and multiple-dose safety after administration of famciclovir oral pediat...
    Medical condition: Chickenpox Herpes Zoster
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000904-40 Sponsor Protocol Number: AN2728-AD-303 Start Date*: 2018-07-23
    Sponsor Name:Pfizer Inc.
    Full Title: A Multicenter, Open-Label Study Of The Long-Term Safety Of AN2728 Topical Ointment, 2% In The Treatment Of Children, Adolescents, And Adults (Ages 2 Years And Older) With Atopic Dermatitis
    Medical condition: Atopic Dermatitis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-003415-46 Sponsor Protocol Number: GT-12 Start Date*: 2006-11-10
    Sponsor Name:ALK-Abello, Group Clinical Development
    Full Title: A phase III trial investigating the efficacy and safety of Grazax in children aged 5-16 years with grass pollen induced rhinoconjunctivitis with or without asthma
    Medical condition: IgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004134-29 Sponsor Protocol Number: VX17-659-105 Start Date*: 2018-08-22
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IE (Completed) ES (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2004-002612-28 Sponsor Protocol Number: CHTF919D2301E1 Start Date*: 2004-11-17
    Sponsor Name:Novartis Pharmaceuticals UK Ltd
    Full Title: A one year, open label, multi-center, extension study to CHTF919D2301 to assess the long term safety of tegaserod 6 mg bid given orally in female patients with symptoms of dyspepsia
    Medical condition: dyspepsia
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-019249-25 Sponsor Protocol Number: 981 Start Date*: 2010-08-12
    Sponsor Name:Biotest AG
    Full Title: An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infu...
    Medical condition: Primary immunodeficiency disease (PID)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010509 Congenital hypogammaglobulinemia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2018-004686-13 Sponsor Protocol Number: LAS-212 Start Date*: 2020-05-01
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement o...
    Medical condition: Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver transplantation
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004441-17 Sponsor Protocol Number: CFAM810B2303 Start Date*: 2016-04-12
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediat...
    Medical condition: Herpes Simplex
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000749-11 Sponsor Protocol Number: IBM-OLE Start Date*: 2019-10-09
    Sponsor Name:Orphazyme A/S
    Full Title: An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4...
    Medical condition: Sporadic Inclusion Body Myositis (sIBM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10075052 Sporadic inclusion body myositis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2009-010334-21 Sponsor Protocol Number: Flu002 Start Date*: 2009-04-17
    Sponsor Name:Oxford University
    Full Title: A phase IIa study to assess the safety and efficacy of a new influenza vaccine candidate MVA-NP+M1 in healthy adults.
    Medical condition: Influenza
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006968-11 Sponsor Protocol Number: AP214-CS005 Start Date*: 2009-04-21
    Sponsor Name:Action Pharma A/S
    Full Title: Pharmacokinectics of AP214 Acetate in patients undergoing cardiac surgery. A randomized, double-blind, placebo-controlled sequential ascending dose trial investigating pharmacokinetics, as well as...
    Medical condition: Action Pharma A/S is developing AP214 Acetate for the prevention of postsurgical kidney injury after thoracic aortic aneurysm repair surgery. In phase 2: Patients undergoing cardiac surgery, defin...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056675 Postoperative renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-012591-27 Sponsor Protocol Number: VAC037 Start Date*: 2009-11-16
    Sponsor Name:University of Oxford
    Full Title: A phase I/IIa study to assess the safety and immunogenicity of new malaria vaccine candidates AdCh63 MSP1 alone and with MVA MSP1
    Medical condition: Plasmodium Falciparum Malaria
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-001874-32 Sponsor Protocol Number: RDC-CNGA3-01 Start Date*: 2015-09-09
    Sponsor Name:Universitätsklinikum Tübingen
    Full Title: Safety and efficacy of a bilateral single subretinal injection of rAAV.hCNGA3 in adult and minor patients with CNGA3-linked achromatopsia investigated in a randomized, wait list controlled, observe...
    Medical condition: CNGA3-linked achromatopsia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10000454 Achromatopsia LLT
    Population Age: Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001547-32 Sponsor Protocol Number: CACZ885U2301 Start Date*: 2018-12-11
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first lin...
    Medical condition: stages AJCC v. 8 IIIB/IIIC (not eligible for definite chemoradiation therapy) or stage IV (metastatic) non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Completed) CZ (Completed) NL (Completed) GR (Completed) ES (Ongoing) IS (Completed) SK (Completed) AT (Completed) PT (Completed) DK (Completed) FI (Completed) SE (Completed) HU (Completed) IT (Completed) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001766-25 Sponsor Protocol Number: CASM981CVE01 Start Date*: 2017-09-28
    Sponsor Name:Novartis
    Full Title: An open label, 52 week, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic der...
    Medical condition: mild to moderate atopic dermatitis
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-001266-38 Sponsor Protocol Number: C3291027 Start Date*: 2021-06-09
    Sponsor Name:Pfizer Inc
    Full Title: A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS
    Medical condition: Atopic dermatitis
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-006754-31 Sponsor Protocol Number: 80101 Start Date*: 2022-03-22
    Sponsor Name:Leiden University Medical Center
    Full Title: Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers
    Medical condition: Safety and immunogenicity after revaccination with Spikevax in healthy adults who have received Comirnaty as a primary vaccine
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
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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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