Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Risk management plan

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   44294   clinical trials with a EudraCT protocol, of which   7351   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    42 result(s) found for: Risk management plan. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2017-005010-59 Sponsor Protocol Number: THERAG0001 Start Date*: 2018-05-17
    Sponsor Name:Theragnostics Ltd
    Full Title: A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients with High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatment
    Medical condition: High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatment
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-005008-32 Sponsor Protocol Number: ICORG13-17 Start Date*: 2014-07-16
    Sponsor Name:Cancer Trials Ireland
    Full Title: A phase II Study of the Efficacy and Safety of lenalidomide, subcutaneous bortezomib, and dexamethasone combination therapy for patients with newly diagnosed multiple myeloma
    Medical condition: Newly diagnosed multiple myeloma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001344-11 Sponsor Protocol Number: CCD-GPLSCD01-03-FU Start Date*: 2018-04-11
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: Multinational, multicenter, prospective, long-term safety and efficacy follow-up study after Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium i...
    Medical condition: corneal lesions with associated moderate to severe limbal stem cell deficiency due to ocular burns
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10011012 Corneal epithelium opacity LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) PL (Completed) FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-006026-28 Sponsor Protocol Number: A3481066 Start Date*: 2006-09-25
    Sponsor Name:Pfizer Pharma GmbH
    Full Title: Randomized, Double-Blind Study of the morphine-sparing efficacy and safety of Parecoxib sodium 40 mg i.v. followed by 20 mg i.v. every 12 hours in the treatment of pain following radical prostatectomy
    Medical condition: Patients who are scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and who are expected to experience moderate to severe postsurgical ...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10054711 Postoperative pain LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003724-23 Sponsor Protocol Number: GI-AU-NMH-2016-01 Start Date*: 2017-12-28
    Sponsor Name:The George Institute for Global Health, University of New South Wales
    Full Title: Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial
    Medical condition: Patients with a history of acute stroke due to Intracranial Haemorrhage with mild to moderately high blood pressure.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10019016 Haemorrhagic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-000197-30 Sponsor Protocol Number: UoL001289 Start Date*: 2018-07-13
    Sponsor Name:The University of Liverpool
    Full Title: Sodium Valproate for Epigenetic Reprogramming in the Management of High Risk Oral Epithelial Dysplasia
    Medical condition: High Risk Oral Epithelial Dysplasia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-003717-18 Sponsor Protocol Number: 215226/VIR-7831-5005 Start Date*: 2021-12-30
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovim...
    Medical condition: COVID-19 at high risk of disease progression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2004-001922-26 Sponsor Protocol Number: BMI-EU-02-008 Start Date*: 2006-01-06
    Sponsor Name:Bioheart, Inc
    Full Title: A Phase II, Open-label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of MyoCellâ„¢ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Pos...
    Medical condition: Patients with congestive heart failure who have had a previous myocardial infarction.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003680-10 Sponsor Protocol Number: AROAPOC3-3001 Start Date*: 2022-01-13
    Sponsor Name:Arrowhead Pharmaceuticals, Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Familial Chylomicronemia Syndrome
    Medical condition: Familial Chylomicronemia Syndrome
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10085051 Familial chylomicronemia syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) FR (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002527-21 Sponsor Protocol Number: AMYPAD-01 Start Date*: 2018-05-23
    Sponsor Name:University of Geneva
    Full Title: Multicentre, Open-label, Randomised Study to Assess the Diagnostic Value of Amyloid PET Imaging in Patients with Subjective Cognitive Decline Plus, Mild Cognitive Impairment, or Dementia Where Alzh...
    Medical condition: Alzheimer's disease Mild Cognitive Impairment Subjective Cognitive Decline Plus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) DE (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022445-20 Sponsor Protocol Number: CA204006 Start Date*: 2011-11-08
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma.
    Medical condition: Untreated Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) ES (Completed) BE (Completed) AT (Completed) GR (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-001285-10 Sponsor Protocol Number: CA209-171 Start Date*: 2015-05-15
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS-936558) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at...
    Medical condition: Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SE (Completed) DE (Ongoing) FI (Completed) DK (Completed) PT (Completed) ES (Ongoing) AT (Completed) GB (GB - no longer in EU/EEA) IE (Completed) GR (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-005427-20 Sponsor Protocol Number: C4601003 Start Date*: 2022-07-13
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6 VALENT OspA-BASED LYME DISE...
    Medical condition: Prevention of Lyme disease caused by Borrelia species in individuals ≥5 years of age by active immunization
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10025169 Lyme disease PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SE (Trial now transitioned) EE (Prematurely Ended) FI (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003866-14 Sponsor Protocol Number: B5091007 Start Date*: 2017-06-15
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study To Evaluate The Efficacy, Safety, And Tolerability Of A Clostridium Difficile Vaccine In Adults 50 Years Of Age And Older
    Medical condition: Primary C difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    20.0 10021881 - Infections and infestations 10012748 Diarrhoea, Clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BG (Completed) SE (Completed) HU (Completed) BE (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) DE (Completed) FI (Completed) PT (Completed) ES (Completed) PL (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-002990-84 Sponsor Protocol Number: MOR208C310 Start Date*: 2021-03-01
    Sponsor Name:MorphoSys AG
    Full Title: A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untre...
    Medical condition: Newly-diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma (DLBCL).
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012820 Diffuse large B-cell lymphoma NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IE (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) SK (Trial now transitioned) HU (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004197-42 Sponsor Protocol Number: CUSP9v3 Start Date*: 2016-08-02
    Sponsor Name:University Hospital of Ulm
    Full Title: A proof of concept clinical trial assessing the safety of the coordinated undermining of survival paths by 9 repurposed drugs combined with metronomic temozolomide (CUSP9v3 Treatment Protocol) for ...
    Medical condition: Glioblastoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-004310-18 Sponsor Protocol Number: SPL-01-001 Start Date*: 2019-10-07
    Sponsor Name:Saving Patients' Lives Medical B.V.
    Full Title: A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unen...
    Medical condition: newly-diagnosed prostate cancer (PCA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Ongoing) NL (Completed) BE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-001462-17 Sponsor Protocol Number: WSG-AM06 Start Date*: 2012-03-29
    Sponsor Name:Westdeutsche Studiengruppe GmbH
    Full Title: Adjuvant Dynamic marker-Adjusted Personalized Therapy trial optimizing risk assessment and therapy response prediction in early breast cancer
    Medical condition: Early primary breast cancer, hormone receptor positve or negative, HER2 positive or negative, any nodal status.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006188 Breast cancer female NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003997-33 Sponsor Protocol Number: NOAH-AFNET6 Start Date*: 2016-11-18
    Sponsor Name:Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]
    Full Title: Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes
    Medical condition: Atrial fibrillation (AF) is one cause of stroke. Stroke rate is increased in patients with atrial high rate episodes (AHRE, an early stage of AF) as well, even if stroke rates are lower when compa...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004849 10003656 Atrial arrhythmia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) AT (Prematurely Ended) NL (Prematurely Ended) BG (Completed) SE (Prematurely Ended) PL (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) PT (Prematurely Ended) GR (Completed) DK (Prematurely Ended) IT (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-002869-18 Sponsor Protocol Number: Start Date*: 2019-09-04
    Sponsor Name:Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
    Full Title: A randomised, double-blind, placebo controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression.
    Medical condition: Bipolar disorder (BD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10012386 Depression mental LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA