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Clinical trials for Chemical safety assessment

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    95 result(s) found for: Chemical safety assessment. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2005-000615-99 Sponsor Protocol Number: 00465 Start Date*: 2006-12-28
    Sponsor Name:University Medical Center Freiburg
    Full Title: Freiburger ZNS-NHL Studie Therapie für Patienten mit primären Non-Hodgkin Lymphomen des ZNS – Sequentielle Hochdosis-Chemotherapie mit autologer peripherer Blutstammzelltransplantation
    Medical condition: primary Non-Hodgkin Lymphoma of the Central Nervous System (PCNSL), histologically confirmed Age: 18 - 65 years
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029614 Non-Hodgkin's lymphoma unspecified histology aggressive stage IV PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000676-33 Sponsor Protocol Number: 292004 Start Date*: 2006-09-14
    Sponsor Name:NV Organon
    Full Title: A randomized, open-label, comparative, multi-center trial to evaluate the effects on hemostasis, lipids and carbohydrate metabolism, and on adrenal and thyroid function of a monophasic COC containi...
    Medical condition: Hormonal oral contraception in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2006-001546-14 Sponsor Protocol Number: 292003 Start Date*: 2006-08-30
    Sponsor Name:NV Organon
    Full Title: A randomized, open-label, comparative trial to evaluate the effects on ovarian function of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg es...
    Medical condition: Hormonal oral contraception in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-002000-42 Sponsor Protocol Number: 19.4.309 Start Date*: 2006-03-29
    Sponsor Name:NV Organon
    Full Title: A multi-center, randomized, parallel-group, placebo-controlled, safety-assessor blinded trial, evaluating the safety and efficacy of Org 25969 in cardiac patients
    Medical condition: Not applicable
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002411-26 Sponsor Protocol Number: UV1/hTERT-2012-P Start Date*: 2013-03-18
    Sponsor Name:Oslo University Hospital
    Full Title: A PHASE I/IIA STUDY OF UV1 VACCINATION IN PATIENTS WITH HORMONE-SENSITIVE METASTATIC PROSTATE CANCER.
    Medical condition: Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to Complete Androgen Blockade therapy (GnRH-agonist combined with anti-androgen).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071119 Hormone-dependent prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002169-35 Sponsor Protocol Number: 25544 Start Date*: 2005-12-27
    Sponsor Name:NV Organon
    Full Title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the safety and Efficacy of Asenapine With Olanzapine in Subjects who Completed Protocol 25543
    Medical condition: Schizophrenia with predominant, persistent negative symptoms
    Disease: Version SOC Term Classification Code Term Level
    7.1 10039626 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) ES (Completed) CZ (Completed) DE (Completed) HU (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007645-31 Sponsor Protocol Number: 00591 Start Date*: 2009-06-23
    Sponsor Name:University Medical Center Freiburg
    Full Title: Freiburger Studie zur Behandlung von Primären ZNS-Lymphomen bei Patienten über 65 Jahre: Methotrexat-basierte Chemo-Immuntherapie mit anschließender Erhaltungstherapie - PRIMAIN-Studie -
    Medical condition: Patients with primary CNS Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10036685 Primary central nervous system lymphoma LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-005304-16 Sponsor Protocol Number: 292001 Start Date*: 2006-06-09
    Sponsor Name:NV Organon
    Full Title: A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2....
    Medical condition: Hormonal oral contraception in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) SE (Completed) DK (Completed) FI (Completed) BE (Completed) DE (Completed) ES (Completed) CZ (Completed) GB (Completed) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-005155-14 Sponsor Protocol Number: PKM11204 Start Date*: 2012-03-22
    Sponsor Name:sanofi-aventis Recherche et Développement
    Full Title: An open-label, pharmacokinetic, pharmacodynamic, and tolerability study of AVE5026 administered at weight-adjusted doses to patients under 18 years of age with a Central Venous Line (CVL)
    Medical condition: Prevention of thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    14.1 10047065 - Vascular disorders 10043566 Thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) ES (Prematurely Ended) SK (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-004897-26 Sponsor Protocol Number: Lu-11829A Start Date*: 2008-05-23
    Sponsor Name:King's College London [...]
    1. King's College London
    2. North Essex Partnership NHS Foundation Trust
    Full Title: Memantine for the Long Term Management of Neuropsychiatric Symptoms in Alzheimer's disease - MAIN-AD
    Medical condition: Alzheimer's disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000301-37 Sponsor Protocol Number: EFC13738 Start Date*: 2018-10-09
    Sponsor Name:Genzyme Corporation
    Full Title: Open label, Two Cohort (with and without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients with Gaucher Disease Type 1 and Type 3
    Medical condition: Congenital, hereditary and neonatal diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10075697 Gaucher's disease type I PT
    20.0 10010331 - Congenital, familial and genetic disorders 10075699 Gaucher's disease type III PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) IT (Trial now transitioned) NL (Ongoing) ES (Ongoing) Outside EU/EEA GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-006673-91 Sponsor Protocol Number: RD.03.SPR.40051 Start Date*: 2008-07-04
    Sponsor Name:GALDERMA R&D SNC
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF CD5024 1% CREAM TREATMENT FOR UP TO 52 WEEKS IN SUBJECTS WITH PAPULOPUSTULAR ROSACEA
    Medical condition: PATIENTS WITH PAPULOPUSTULAR ROSACEA
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039218 Rosacea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) HU (Completed) IS (Prematurely Ended) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2004-000469-36 Sponsor Protocol Number: 46101 Start Date*: 2004-11-08
    Sponsor Name:NV Organon
    Full Title: A multicenter, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the efficacy and safety of four different doses of Org 50081 in the treatment of moderate to severe vas...
    Medical condition: moderate to severe vasomotor symptoms associated with the menopause
    Disease: Version SOC Term Classification Code Term Level
    7.0 10020411 LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000472-14 Sponsor Protocol Number: 177001 Start Date*: 2004-11-17
    Sponsor Name:Organon Hungary Ltd.
    Full Title: A multicenter, randomized, parallel-group, double- blind, placebo-controlled trial to evaluate the efficacy and safety of four different doses of Org 50081 in the treatment of moderate to severe va...
    Medical condition: moderate to severe vasomotor symptoms associated with the menopause
    Disease: Version SOC Term Classification Code Term Level
    7.0 10020411 LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-018319-13 Sponsor Protocol Number: RD.03.SPR.40106 Start Date*: 2010-08-17
    Sponsor Name:GALDERMA R&D SNC
    Full Title: A DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE ACTIVITY OF CD5024 1% CREAM IN SUBJECTS WITH PAPULOPUSTULAR ROSACEA OVER 12 WEEKS TREATMENT
    Medical condition: PATIENTS WITH PAPULOPUSTULAR ROSACEA
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039218 Rosacea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) FI (Completed) SK (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2004-002560-17 Sponsor Protocol Number: 25543 Start Date*: 2005-04-14
    Sponsor Name:NV Organon
    Full Title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizop...
    Medical condition: Schizophrenia with predominant, persistent negative symptoms
    Disease: Version SOC Term Classification Code Term Level
    7.1 10039626 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Prematurely Ended) SE (Completed) DE (Completed) CZ (Completed) GB (Completed) IT (Completed) ES (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2007-001872-36 Sponsor Protocol Number: CT:EP02 Start Date*: 2007-09-05
    Sponsor Name:EctoPharma Limited
    Full Title: A Multicentre Phase III trial of 1,2-octanediol at 5%(w/v (KindaPed™) compared with Malathion 0.5% (w/v) (Derbac-M Liquid) in the treatment of head lice
    Medical condition: Head louse infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019197 Head lice LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005234-21 Sponsor Protocol Number: P04843 Start Date*: 2007-11-28
    Sponsor Name:Schering-Plough Research Institute
    Full Title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid-Dependent Subjects.
    Medical condition: Opioid dependance
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013663 Drug dependence LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) SE (Completed) PT (Completed) DK (Completed) LT (Completed) SI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-007657-31 Sponsor Protocol Number: MIARCU 01/2008 Start Date*: 2008-06-23
    Sponsor Name:Charité-University Berlin
    Full Title: Efficacy and safety of Miltefosine in antihistamine resistant chronic urticaria
    Medical condition: Urticaria characterized by mast cell and histamine-dependent wheal and flair type-skin responses associated with severe pruritus. The disease is very common and not always easy to treat. Mainstay t...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001852-20 Sponsor Protocol Number: UV1/hTERT-2012-L Start Date*: 2013-01-17
    Sponsor Name:Oslo University Hospital
    Full Title: A PHASE I/IIa STUDY OF UV1 VACCINATION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER
    Medical condition: Patient with metastatic Non Small Cell Lung Cancer (NSCLC) stage IV.
    Disease: Version SOC Term Classification Code Term Level
    15.0 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: NO (Completed)
    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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