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Clinical trials for Drug 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   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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    11,447 result(s) found for: Drug Safety. Displaying page 243 of 573.
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    EudraCT Number: 2010-022914-15 Sponsor Protocol Number: A3051123 Start Date*: 2012-03-01
    Sponsor Name:Pfizer, S.L.U.
    Full Title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO -CONTROLLED, MULTICENTER STUDY EVALUATING THE NEUROPSYCHIATRIC SAFETY AND EFFICACY OF 12 WEEKS VARENICLINE TARTRATE 1MG BID AND BUPROPION HYD...
    Medical condition: Nicotine Addiction with the desire to quit smoking
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10053325 Smoking cessation therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) DK (Completed) FI (Completed) BG (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2021-002729-74 Sponsor Protocol Number: PQ-421a-003 Start Date*: Information not available in EudraCT
    Sponsor Name:ProQR Therapeutics IV B.V.
    Full Title: A Double-Masked, Randomized, Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety and Tolerability of QR-421a in Subjects with Retinitis Pigmentosa (RP) due to Mutations in Exon 13 of t...
    Medical condition: Retinitis Pigmentosa (RP) due to Mutations in Exon 13 of the USH2A Gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NO (Completed) DK (Completed) NL (Ongoing) IT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001718-13 Sponsor Protocol Number: MP18 Start Date*: 2019-10-18
    Sponsor Name:MAPS Europe B.V.
    Full Title: An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Dis...
    Medical condition: post-traumatic stress disorder (PTSD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) CZ (Completed) NO (Completed) DE (Completed) GB (GB - no longer in EU/EEA) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000607-25 Sponsor Protocol Number: KCP-330-024BGOG-EN5/ENGOT-EN5/SIEND Start Date*: 2017-11-22
    Sponsor Name:Karyopharm Therapeutics Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer
    Medical condition: Selinexor/placebo will be given as maintenance therapy after combination chemotherapy for patients with advanced endometrial cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014733 Endometrial cancer PT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014734 Endometrial cancer metastatic PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014736 Endometrial cancer recurrent PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) PL (Completed) IT (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000335-40 Sponsor Protocol Number: GA29350 Start Date*: 2016-08-23
    Sponsor Name:Genentech, Inc.
    Full Title: A TWO-COHORT RANDOMIZED PHASE II, DOUBLEBLIND, PARALLEL GROUP STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS EVALUATING THE EFFICACY AND SAFETY OF GDC-0853 COMPARED WITH PLACEBO AND ADALIMUMAB ...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-004258-14 Sponsor Protocol Number: 201579 Start Date*: 2017-02-21
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-α Monoclonal Antibody (GSK2618960) in ...
    Medical condition: Primary Sjögren’s Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10021295 IL-7 therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004333-27 Sponsor Protocol Number: SMTC11005 Start Date*: 2016-01-19
    Sponsor Name:Summit (Oxford) Limited
    Full Title: A Phase 2 Clinical Study to Assess the Activity and Safety of Utrophin Modulation with SMT C1100 in Ambulatory Paediatric Male Subjects with Duchenne Muscular Dystrophy (C11005)
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-001661-40 Sponsor Protocol Number: DE038 Start Date*: 2012-02-07
    Sponsor Name:Abbott Laboratories
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Juvenile Rheuma...
    Medical condition: Polyarticular Juvenile Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10036039 Polyarticular juvenile rheumatoid arthritis, chronic or unspecified LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000137-52 Sponsor Protocol Number: IFN-K-005-DM Start Date*: 2016-07-26
    Sponsor Name:Neovacs SA
    Full Title: A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects with Dermatomyositis.
    Medical condition: Dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-002126-23 Sponsor Protocol Number: APOCT-002 Start Date*: 2013-09-06
    Sponsor Name:Apodemus AB
    Full Title: A randomized, double blind, placebo controlled trial to evaluate the safety and efficacy of Apovir for treatment of patients with Alzheimer’s disease
    Medical condition: Alzheimer's disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002295-87 Sponsor Protocol Number: LDCD-001 Start Date*: 2014-10-13
    Sponsor Name:SynAgile Corporation
    Full Title: A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administ...
    Medical condition: Parkinson's disease patients who suffer motor fluctuations will participate in the study
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003866-42 Sponsor Protocol Number: IRFMN-OVA-6152 Start Date*: 2012-12-13
    Sponsor Name:IST. DI RICERCHE FARMACOLOG. M. NEGRI
    Full Title: Multicenter, randomized, non-comparative, open-label phase II trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with pla...
    Medical condition: adult women with platinum partially sensitive recurring ovarian cancer.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10033271 Ovarian neoplasia LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000878-11 Sponsor Protocol Number: OMO1.01.02 Start Date*: 2017-06-08
    Sponsor Name:OCTIMET Oncology NV
    Full Title: A modular, multi-arm, multi-part, first time in patient study to evaluate the safety and tolerability of OMO-1, alone and in combination with anti-cancer treatments, in patients with locally advanc...
    Medical condition: Locally advanced, unresectable or metastatic solid malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) NL (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002251-38 Sponsor Protocol Number: VX20-445-111 Start Date*: 2021-09-28
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age
    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: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-001828-15 Sponsor Protocol Number: SynAct-CS007 Start Date*: 2022-09-14
    Sponsor Name:SynAct Pharma ApS
    Full Title: A double-blind, multi-center, randomized, placebo-controlled study of the safety and efficacy of 12 weeks extended treatment with AP1189 in early rheumatoid arthritis (RA) patients naïve to DMARD t...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004859 10003268 Arthritis rheumatoid LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004216-22 Sponsor Protocol Number: C602 Start Date*: 2019-09-25
    Sponsor Name:Soleno Therapeutics UK Ltd.
    Full Title: An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome
    Medical condition: Hyperphagia associated with Prader-Willi Syndrome (PWS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020710 Hyperphagia PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2022-003126-42 Sponsor Protocol Number: DT-DEC01-DMD-CT-Phase1/2 Start Date*: 2023-12-12
    Sponsor Name:Dystrogen Therapeutics Technology Polska Spółka z Ograniczoną Odpowiedzialnością
    Full Title: A Phase 1/2, Open-Label, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of DT-DEC01 Therapy in Patients with Duchenne Muscular Dystrophy
    Medical condition: Duchenne muscular dystrophy (DMD) is the most common inherited neuromuscular disease that mostly affects boys. DMD is a type of X-linked disease caused by a mutation of the gene at the Xp21 locus t...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003331-36 Sponsor Protocol Number: FER-Loxapine-2015-01 Start Date*: 2016-03-16
    Sponsor Name:FERRER INTERNACIONAL SA
    Full Title: A Phase IV, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety of self-administered ADASUVE(R) (Staccato loxapine for inhalation) in Agitated Patients outside the hospital setting
    Medical condition: Mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2010-020448-37 Sponsor Protocol Number: ENC-0303-CL-203 Start Date*: 2011-12-21
    Sponsor Name:Enceladus Pharmaceuticals
    Full Title: Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative ...
    Medical condition: Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003320-36 Sponsor Protocol Number: 190342-038 Start Date*: 2015-03-02
    Sponsor Name:Allergan Limited
    Full Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON Study)
    Medical condition: Geographic Atrophy Secondary to Age-related Macular Degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10025409 Macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended)
    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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