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Clinical trials for Exposure Action Value

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   44334   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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    17 result(s) found for: Exposure Action Value. Displaying page 1 of 1.
    EudraCT Number: 2019-002847-62 Sponsor Protocol Number: TCS_19_02 Start Date*: 2020-05-28
    Sponsor Name:Marinomed Biotech AG
    Full Title: Clinical evaluation of two different dosage groups of Tacrosolv over 8 days with once daily administration in a placebo controlled cross-over design to evaluate safety and efficacy in patients suff...
    Medical condition: Allergic rhinoconjunctivitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001728 Allergic rhinoconjunctivitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-002062-62 Sponsor Protocol Number: ALS-TAL-201 Start Date*: 2008-10-14
    Sponsor Name:Teva Pharmaceutical Industries, Ltd
    Full Title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral S...
    Medical condition: Amyotrophic lateral sclerosis (ALS).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052653 Amyotrophic lateral sclerosis gene carrier PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FR (Completed) ES (Completed) IT (Completed) BE (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001132-22 Sponsor Protocol Number: GEM-1202 Start Date*: 2014-02-24
    Sponsor Name:Grupo Español Multidisciplinar de Melanoma
    Full Title: A MULTICENTER, SINGLE ARM, PHASE 2 CLINICAL STUDY ON THE COMBINATION OF RADIATION THERAPY AND IPILIMUMAB, FOR THE TREATMENT OF PATIENTS WITH MELANOMA AND BRAIN METASTASES.
    Medical condition: Patients with melanoma and brain metastases
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004169-33 Sponsor Protocol Number: P04705 Start Date*: 2007-10-16
    Sponsor Name:Schering-Plough Research Institute, a division of Schering Corporation
    Full Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50 mcg BID Delivered by Dry Powder Inhaler (DISKUS®) Versus Mometasone Furoate/Formoterol Fumarate 200/1...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10003553 Asthma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) EE (Prematurely Ended) LT (Prematurely Ended) LV (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) SK (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000048-73 Sponsor Protocol Number: AMT-101-201 Start Date*: 2020-09-24
    Sponsor Name:Applied Molecular Transport Inc.
    Full Title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
    Medical condition: Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) HU (Completed) DE (Completed) NL (Completed) BE (Completed) IT (Completed) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001855-38 Sponsor Protocol Number: 8237-003 Start Date*: 2012-09-03
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 using an Environmental Exposure Chamber in Subjects with House Dust induced Alle...
    Medical condition: House Dust Induced Rhinitis/Rhinoconjunctivitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10001723 Allergic rhinitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004346-42 Sponsor Protocol Number: 3150-301-008 Start Date*: 2019-09-10
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikuma...
    Medical condition: Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10011402 Crohn's disease (colon) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) ES (Prematurely Ended) BG (Prematurely Ended) AT (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) BE (Not Authorised) IT (Prematurely Ended) SK (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-001253-82 Sponsor Protocol Number: I2R-MC-BIAO Start Date*: 2011-12-02
    Sponsor Name:Eli Lilly and Company
    Full Title: Protocol I2R-MC-BIAO The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52 Week Study ...
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10045228 Type I diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) LT (Completed) BE (Completed) ES (Completed) IE (Completed) DK (Completed) GR (Completed) NL (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2010-020841-29 Sponsor Protocol Number: ADAPT Start Date*: 2011-07-07
    Sponsor Name:King`s College London [...]
    1. King`s College London
    2. Guy`s & St Thomas` NHS Foundation Trust
    Full Title: The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
    Medical condition: Severe eczema in children
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10003641 Atopic eczema LLT
    19.0 100000004858 10014189 Eczema allergic atopic LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-001254-29 Sponsor Protocol Number: I2R-MC-BIAM Start Date*: 2012-01-24
    Sponsor Name:Eli Lilly and Company
    Full Title: Protocol I2R-MC-BIAM The Impact of LY2605541 versus Insulin Glargine for Patients with Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin with Insulin Lispro: a Double-Blind, R...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10049746 Insulin-requiring type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) SK (Completed) GB (Completed) CZ (Completed) AT (Completed) ES (Completed) LT (Completed) GR (Completed) IT (Completed) DK (Completed) NL (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2017-001219-35 Sponsor Protocol Number: COR-2017-01 Start Date*: 2018-01-22
    Sponsor Name:Cortendo AB
    Full Title: A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenou...
    Medical condition: Endogenous Cushing´s syndrome (CS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004860 10011657 Cushings syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) BG (Completed) HU (Completed) PL (Completed) NL (Completed) DK (Prematurely Ended) GR (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2014-001916-20 Sponsor Protocol Number: 191-079 Start Date*: 2014-09-18
    Sponsor Name:Mylan Pharma UK Ltd
    Full Title: A Randomized, Double-Blind, Parallel Group 24 Week Placebo-Controlled Efficacy and Safety Study with a 28 Week Long Term Extension, of Nebulized Fluticasone Propionate (FP) /Formoterol Fumarate (FF...
    Medical condition: Chronic Obstructive Pulmonary Disease.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) SK (Prematurely Ended) SE (Prematurely Ended) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004842-92 Sponsor Protocol Number: SECOMBIT Start Date*: 2016-06-30
    Sponsor Name:FONDAZIONE MELANOMA ONLUS
    Full Title: A three arms prospective, randomized phase II study to evaluate the best sequential approach with combo immunotherapy (ipilimumab/nivolumab) and combo target therapy (LGX818/MEK162) in patients wit...
    Medical condition: Metastatic melanoma and BRAF mutation
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10053571 Melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Ongoing) DE (Completed) GR (Completed) AT (Prematurely Ended) GB (GB - no longer in EU/EEA) SE (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020803-63 Sponsor Protocol Number: AB07015 Start Date*: 2010-10-18
    Sponsor Name:AB Science
    Full Title: A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the t...
    Medical condition: Severe Persistent Asthma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prohibited by CA) CZ (Completed) BG (Completed) DE (Prematurely Ended) SK (Completed) ES (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-001165-27 Sponsor Protocol Number: 191-078 Start Date*: 2014-11-06
    Sponsor Name:Mylan Pharma UK Ltd
    Full Title: A Randomized, Double-Blind, Parallel Group 24 Week Placebo-Controlled Efficacy and Safety Study with a 28 Week Long Term Extension, of Nebulized Fluticasone Propionate (FP) /Formoterol Fumarate (FF...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001261-40 Sponsor Protocol Number: I2R-MC-BIAN Start Date*: 2012-03-05
    Sponsor Name:Eli Lilly and Company
    Full Title: Protocol I2R-MC-BIAN (a) Study: The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: an Open-Label, Randomized, 78 w...
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004861 10045228 Type I diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001304-37 Sponsor Protocol Number: 205715 Start Date*: 2016-11-09
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual co...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) ES (Completed) PL (Completed) GB (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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