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Clinical trials for Safety data sheet

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 ).  
     
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    54 result(s) found for: Safety data sheet. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2004-001264-45 Sponsor Protocol Number: LU 02-030 study No. 10402: Start Date*: 2005-04-06
    Sponsor Name:H. Lundbeck A/S
    Full Title: Protocol title study No. 10402: A 12-month Phase III safety study of gaboxadol 10 mg daily consisting of a 6-month double-blind, randomised, placebo-controlled, parallel-group periodfollowed by a...
    Medical condition: Elderly outpatients with primary insomnia, diagnosed according to DSM IV-TR
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005696-18 Sponsor Protocol Number: IPR/14 Start Date*: 2007-12-29
    Sponsor Name:MOLMED
    Full Title: NGR008 A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by advanced or metastatic hepatocellular carcinoma HCC previously treated with no more than on...
    Medical condition: Patients affected by advanced or metastatic hepatocellular carcinoma HCC previously treated with no more than one systemic therapeutic regimen
    Disease: Version SOC Term Classification Code Term Level
    9.1 10055110 Hepatic cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-005700-14 Sponsor Protocol Number: IPR/13 Start Date*: 2006-12-29
    Sponsor Name:MOLMED
    Full Title: NGR007 A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by advanced or metastatic small cell lung carcinoma SCLC previously treated with no more than ...
    Medical condition: patients affected by advanced or metastatic small cell lung carcinoma SCLC previously treated with no more than one therapeutic regimen
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059514 Small cell lung cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003810-42 Sponsor Protocol Number: Version2.0;18/12/2013 Start Date*: 2016-06-24
    Sponsor Name:University of Edinburgh (ACCORD) [...]
    1. University of Edinburgh (ACCORD)
    2. NHS Lothian (ACCORD)
    Full Title: A pragmatic group sequential placebo controlled randomised trial to determine the effectiveness of Glyceryl trinitrate for retained placenta (GOT-IT Trial)
    Medical condition: Retained placenta
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004868 10038757 Retained placenta LLT
    16.1 100000004865 10038350 Removal retained placenta LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001622-64 Sponsor Protocol Number: TAC-COVID19 Start Date*: 2020-04-19
    Sponsor Name:Dra Ana Pueyo Bastida
    Full Title: OUTPATIENT TREATMENT OF COVID-19 WITH EARLY PULMONARY CORTICOSTEROIDS AS AN OPPORTUNITY TO MODIFY THE COURSE OF THE DISEASE
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004240-30 Sponsor Protocol Number: PS-ISA-01 Start Date*: 2020-01-24
    Sponsor Name:FUNDACIÓN PARA LA INVESTIGACION BIOMEDICA HU PUERTA DE HIERRO MAJADAHONDA
    Full Title: Phase IV, unicentric, multiple dose, clinical trial, with a single treatment arm to evaluate bronchopulmonary penetration of isavuconazole in pulmonary transplant recipients (PBISA01)
    Medical condition: Lung transplant recipients with a diagnosis of invasive fungal disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001409-21 Sponsor Protocol Number: IMIB-DFC-2020-02 Start Date*: 2020-04-01
    Sponsor Name:FFIS
    Full Title: A prospective, multicenter, randomized, parallel, double-blind, placebo-controlled phase IIb clinical trial to evaluate intravenous infusion of Defibrotide in the prevention and treatment of respir...
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000302-28 Sponsor Protocol Number: EffICIENCY Start Date*: 2020-05-04
    Sponsor Name:Mundipharma Pharmaceuticals S.L.
    Full Title: Open randomized low interventional clinical trial to compare efficiency in symptom control between fluticasone propionate/formoterol k-haler at medium strength versus an high strength ICS/LABA for ...
    Medical condition: Persistent moderate asthma uncontrolled
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-005993-39 Sponsor Protocol Number: IPR/16 Start Date*: 2007-04-26
    Sponsor Name:MOLMED
    Full Title: NGR010: A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than on...
    Medical condition: patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic
    Disease: Version SOC Term Classification Code Term Level
    6.1 10035605 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002281-23 Sponsor Protocol Number: Spon1345-14 Start Date*: 2016-06-13
    Sponsor Name:Cardiff University
    Full Title: A phase 2 study of the monocyte-targeted histone deacetylase inhibitor tefinostat (CHR-2845) in chronic myelomonocytic leukaemia (CMML)
    Medical condition: Chronic myelomonocytic leukaemia (CMML)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-006474-28 Sponsor Protocol Number: NBI-56418-0703 Start Date*: 2008-05-14
    Sponsor Name:Neurocrine Biosciences, INC
    Full Title: A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with Endometriosis
    Medical condition: Endometriosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10014778 Endometriosis LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) PL (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001790-25 Sponsor Protocol Number: FP01C-13-001 Start Date*: 2014-09-01
    Sponsor Name:Foresee Pharmaceuticals Co., Ltd.
    Full Title: An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects with Advanced Prostate Carcinoma
    Medical condition: Advanced Prostate Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10036921 Prostate carcinoma LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Completed) DE (Completed) CZ (Completed) SK (Completed) LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-000222-19 Sponsor Protocol Number: H2020-PHC-18-2015-667224 Start Date*: 2017-08-02
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome – a blinded randomized placebo-controlled parallel group multicenter trial for superiori...
    Medical condition: Perinatal Asphyxia, hypoxic-ischemic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    20.0 10029205 - Nervous system disorders 10014633 Encephalopathy neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) NO (Trial now transitioned) ES (Ongoing) FI (Trial now transitioned) EE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) PT (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021531-13 Sponsor Protocol Number: UCL/10/0035 Start Date*: 2011-02-17
    Sponsor Name:Joint UCLH and UCL Biomedical Research Unit
    Full Title: Multi-centre, randomised, double-blind phase II study comparing cediranib (AZD2171) plus gefitinib (Iressa, ZD1839) with cediranib plus placebo in subjects with recurrent/progressive glioblastoma (...
    Medical condition: Glioblastoma
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-004662-33 Sponsor Protocol Number: C/39/2018 Start Date*: 2019-07-12
    Sponsor Name:Imperial College London
    Full Title: NOVEL: Nonavalent HPV vaccine after local conservative treatment for cervical pre-invasive disease - a randomised controlled trial
    Medical condition: Cervical intra-epithelial neoplasia
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-001791-13 Sponsor Protocol Number: OXY4009 Start Date*: 2005-08-31
    Sponsor Name:Mundipharma GmbH
    Full Title: An open-label, randomized, parallel-group, monocenter study to evaluate safety and efficacy of Oxycodone Hydrochloride administered orally (CR) and intravenously in patients with total hip endopros...
    Medical condition: Male and female patients who are designated for a total hip endoprosthesis
    Disease: Version SOC Term Classification Code Term Level
    7.1 10044088 low
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-001180-11 Sponsor Protocol Number: ML20514 Start Date*: 2009-03-16
    Sponsor Name:Roche Pharma AG
    Full Title: An Open-label, single-arm, Phase II study to evaluate the efficacy and the feasibility of bevacizumab (Avastin®) based on a FOLFOXIRI regimen until progression in patients with previously untreated...
    Medical condition: previously untreated metastatic colorectal carcinoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10010036 Colorectal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-001729-11 Sponsor Protocol Number: CR040301 Start Date*: 2005-02-18
    Sponsor Name:EBEWE Pharma Ges.m.b.H Nfg.KG
    Full Title: A prospective, randomised, placebo controlled, double blind trial about safety and efficacy of combined treatment with Alteplase (rt-PA) and Cerebrolysin in acute ischemic hemispheric stroke
    Medical condition: Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defin...
    Disease: Version SOC Term Classification Code Term Level
    6.0 10055221 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) CZ (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2011-005270-35 Sponsor Protocol Number: INMI/002/11 Start Date*: 2011-12-07
    Sponsor Name:ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
    Full Title: HIV-infected pregnant women treated with HAART: registry of pharmacokinetic parameters of new and commonly used antiretrovirals
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008922 Chronic infection with HIV LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002101-62 Sponsor Protocol Number: HM13/10758 Start Date*: 2014-12-29
    Sponsor Name:University of Leeds
    Full Title: Pomalidomide in relapsed and refractory multiple myeloma (RRMM)
    Medical condition: Relapsed and Refractory Multiple Myeloma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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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