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Clinical trials for Tolerability

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   44358   clinical trials with a EudraCT protocol, of which   7384   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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    14,038 result(s) found for: Tolerability. Displaying page 442 of 702.
    EudraCT Number: 2021-000510-42 Sponsor Protocol Number: 80202135ARA2001 Start Date*: 2021-09-17
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with...
    Medical condition: Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003825-27 Sponsor Protocol Number: 263CS201 Start Date*: 2020-06-02
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Phase 2, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIIB104 in Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-003088-22 Sponsor Protocol Number: R668-AD-1924 Start Date*: 2021-01-07
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Moderate-to-Severe Atopic H...
    Medical condition: Atopic hand and foot dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012431 Dermatitis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-005226-26 Sponsor Protocol Number: HIPRA-HH-2 Start Date*: 2021-11-15
    Sponsor Name:HIPRA SCIENTIFIC
    Full Title: A Phase IIb, double-blind, randomized, active controlled, multi-centre, non-inferiority trial followed by a Phase III, single arm, open label trial, to assess immunogenicity and safety of a booster...
    Medical condition: SARS-CoV-2
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003118-26 Sponsor Protocol Number: RAMSES/FLOT7 Start Date*: 2016-04-26
    Sponsor Name:Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    Full Title: RAMSES / FLOT7 Perioperative RAMucirumab in combination with FLOT versus FLOT alone for reSEctable eSophagogastric adenocarcinoma RAMSES - a phase II/III trial of the AIO
    Medical condition: locally advanced resectable adenocarcinoma of the esophagogastric junction or the stomach
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062878 Gastrooesophageal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000656-99 Sponsor Protocol Number: REMPEX-507 Start Date*: 2023-09-28
    Sponsor Name:Rempex Pharmaceuticals-Melinta Therapeutics
    Full Title: An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE® (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years o...
    Medical condition: Suspected or confirmed negative bacterial infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    20.0 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-001894-26 Sponsor Protocol Number: CP-PRO-QVLP-014 Start Date*: 2018-10-18
    Sponsor Name:Medicago R&D Inc.
    Full Title: A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Ad...
    Medical condition: Seasonal influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2018-000031-28 Sponsor Protocol Number: CLKA651X2202 Start Date*: 2019-04-11
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, active-controlled, patient and investigator-masked, multiple dose proof-of-concept study of intravitreal LKA651 in patients with diabetic macular edema
    Medical condition: diabetic macular edema
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002499-29 Sponsor Protocol Number: ALXN1210-aHUS-312 Start Date*: 2017-05-18
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)
    Medical condition: Atypical Hemolytic Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10019515 Hemolytic uremic syndrome LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed) SE (Prematurely Ended) ES (Ongoing) BE (Completed) IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-000073-24 Sponsor Protocol Number: CTRIAL-IE-19-33 Start Date*: 2020-09-07
    Sponsor Name:Cancer Trials Ireland
    Full Title: Paricalcitol Trial: Phase II, Open label clinical trial of Paricalcitol in combination with Gemcitabine/ Nab-Paclitaxel therapy in advanced pancreatic cancer.
    Medical condition: Advanced pancreatic cancer.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10033605 Pancreatic cancer metastatic LLT
    21.0 100000004864 10033606 Pancreatic cancer non-resectable LLT
    21.0 100000004864 10033607 Pancreatic cancer recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2017-003940-19 Sponsor Protocol Number: 331-14-213 Start Date*: 2018-08-06
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo controlled, 2 Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatme...
    Medical condition: Agitation Associated With Dementia of the Alzheimer’s Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) ES (Ongoing) HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2021-003602-41 Sponsor Protocol Number: 2020-012-GLOB2 Start Date*: 2022-11-15
    Sponsor Name:HUTCHMED Limited
    Full Title: AN OPEN-LABEL, MULTICENTER PHASE 1/2 STUDY OF SURUFATINIB IN COMBINATION WITH GEMCITABINE IN PEDIATRIC, ADOLESCENT, AND YOUNG ADULT PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS
    Medical condition: recurrent or refractory solid tumors or lymphoma (not central nervous system) who have a known or expected dysfunction of vascular endothelial growth factor receptor-1, -2, and -3; fibroblast growt...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Prematurely Ended) ES (Ongoing) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000282-20 Sponsor Protocol Number: EBS-101-OL-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Emalex Biosciences, Inc.
    Full Title: A Multicenter, Open-Label, Extension Study Intended to Evaluate the Long-term Safety of Ecopipam Tablets in Children and Adolescent Subjects with Tourette’s Syndrome
    Medical condition: Children and Adolescent Subjects with Tourette’s Syndrome greater than or equal to 6 and less than or equal to 18 years of age
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-004445-17 Sponsor Protocol Number: AP30663-2001 Start Date*: 2021-06-29
    Sponsor Name:Acesion Pharma ApS
    Full Title: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study of AP30663 Given Intravenously for Cardioversion in Patients with Atrial Fibrillation
    Medical condition: Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-002945-39 Sponsor Protocol Number: CM-101-PSC-101 Start Date*: 2020-04-15
    Sponsor Name:ChemomAb Ltd
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003847-22 Sponsor Protocol Number: ICORG11-04 Start Date*: 2012-02-02
    Sponsor Name:ICORG
    Full Title: ECOG 2809: Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy
    Medical condition: Patients with Rising PSA at high risk of Prostate cancer progression
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071119 Hormone-dependent prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003386-35 Sponsor Protocol Number: INSIGHT-016 Start Date*: 2021-09-01
    Sponsor Name:Regents of the University of Minesota
    Full Title: SARS-CoV-2 vaccination strategies in previous hospitalised and recovered COVID-19 patients
    Medical condition: Participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sus...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2016-001384-37 Sponsor Protocol Number: ECU-MG-303 Start Date*: 2020-10-07
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG)
    Medical condition: Refractory Generalized Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-005639-65 Sponsor Protocol Number: GEICAM/2017-01_IBCSG62-20_BIG18-04 Start Date*: 2021-05-25
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: A randomized phase III trial of trastuzumab + ALpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced BrEasT cancer. “ALPHABET ...
    Medical condition: PIK3CA mutated HER2+ advanced or relapsed breast cancer (BC) previously treated with trastuzumab and trastuzumab emtansine (T-DM1)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) AT (Completed) FR (Prematurely Ended) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-003309-79 Sponsor Protocol Number: MK-8591-024 Start Date*: 2021-04-30
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender...
    Medical condition: HIV Preexposure prophylaxis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) Outside EU/EEA
    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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