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Clinical trials for 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   44352   clinical trials with a EudraCT protocol, of which   7379   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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    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.
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    27,979 result(s) found for: SAFETY. Displaying page 534 of 1,399.
    EudraCT Number: 2014-004925-42 Sponsor Protocol Number: P04824 Start Date*: 2015-04-13
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis
    Medical condition: Acute Bacterial Sinusitis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003345-29 Sponsor Protocol Number: 3568 Start Date*: 2016-11-16
    Sponsor Name:Kings College Hospital NHS Foundation Trust
    Full Title: Safety of tenofovir alafenamide (TAF) in patients with a history of tubulopathy on tenofovir disoproxil fumarate (TDF)
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-003972-42 Sponsor Protocol Number: A1281198 Start Date*: 2020-08-21
    Sponsor Name:Pfizer, Inc.
    Full Title: A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPO...
    Medical condition: Bipolar Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10004938 Bipolar disorders HLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-000061-37 Sponsor Protocol Number: PR-002 Start Date*: 2008-04-02
    Sponsor Name:EURAND SPA
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase™ (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreati...
    Medical condition: Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003635-23 Sponsor Protocol Number: XIG-AP 1 Start Date*: 2008-08-14
    Sponsor Name:Central Manchester and Manchester Children's Hospitals NHS Trust
    Full Title: A PRELIMINARY EVALUATION OF THE SAFETY PROFILE OF TWENTY-FOUR HOUR INFUSION OF HUMAN RECOMBINANT ACTIVATED PROTEIN C (XIGRIS) EARLY IN SEVERE ACUTE PANCREATITIS.
    Medical condition: Severe acute pancreatitis in man (with an APACHE II score of ≥ 15) appears to carry a considerably higher risk of death when compared to general critical care patients with similar APACHE II scores...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033647 Pancreatitis acute LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-006488-22 Sponsor Protocol Number: E2007-G000-227 Start Date*: 2007-10-03
    Sponsor Name:Eisai Limited
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients with Painful Diabetic Neuropathy
    Medical condition: Painful Diabetic Neuropathy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012680 Diabetic neuropathy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-006358-86 Sponsor Protocol Number: ATG003-201 Start Date*: 2007-04-27
    Sponsor Name:CoMentis, Inc., USA
    Full Title: A PHASE II RANDOMIZED, DOUBLE-MASKED, STUDY COMPARING THE SAFETY AND EFFICACY OF ATG003 (MECAMYLAMINE HCL) 1.0% and 0.3% OPHTHALMIC SOLUTIONS TO PLACEBO IN PATIENTS WITH NEOVASCULAR ("WET") AGE-REL...
    Medical condition: Neovascular ("wet") Age-related Macular Degeneration (NV- AMD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064930 Age-related macular degeneration LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-007769-21 Sponsor Protocol Number: H9D-SB-ITAE Start Date*: 2009-09-11
    Sponsor Name:Lilly Deutschland GmbH
    Full Title: A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults with Type 1 Diabetes: Novel Pen with Memory Function (HumaPen® Memoir) v...
    Medical condition: Pts with type 1 diabetes mellitus based on the WHO criteria, at least 8 years old, used an insulin pen device to inject at least 4 insulin doses/day for at least 2 months prior to the study and cur...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012602 Diabetes mellitus (incl subtypes) HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-006902-27 Sponsor Protocol Number: ALN-RSV01-105 Start Date*: 2007-04-18
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: A randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety and efficacy of intranasal ALN-RSV01 administered to adult volunteers experimentally inoculated with R...
    Medical condition: Experimentally induced Respiratory Syncytial Virus infection. The experimental infectious dose has been titrated in a previous study in healthy volunteers.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052200 Respiratory syncytial virus infection NOS LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-003529-26 Sponsor Protocol Number: 0431-073 Start Date*: 2008-01-18
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Di...
    Medical condition: Type II Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-005113-21 Sponsor Protocol Number: RDEA806-202 Start Date*: 2008-11-20
    Sponsor Name:Ardea Biosciences, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Phase 2b Trial to Determine The Efficacy, Tolerability And Safety Of 3 Dose Regimens Of RDEA806 and Open-Label Efavirenz as Active Control in HIV 1-Infected...
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-001036-23 Sponsor Protocol Number: CASM981C2442 Start Date*: 2004-11-05
    Sponsor Name:Novartis Sverige AB
    Full Title: A 12-week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of El...
    Medical condition: atopic dermatitis (atopic eczema)
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-004958-63 Sponsor Protocol Number: CFTY720 0125E1 Start Date*: 2005-08-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A two-year extension to a one-year, multicenter, partially blinded, double-dummy, randomized study to evaluate the efficacy and safety of FTY720 combined with reduced-dose or full-dose Neoral and c...
    Medical condition: Prophylaxis of kidney allograft rejection in de novo adult renal transplant recipients
    Disease: Version SOC Term Classification Code Term Level
    7.0 10023439 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005215-98 Sponsor Protocol Number: IUWP2005.01 Start Date*: 2007-03-12
    Sponsor Name:Sanquin Plasma Products
    Full Title: Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.
    Medical condition: Established diagnosis of IgG subclass deficiency, and/or (selective) antipolysaccharide antibody deficiency.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10021275 IgG subclass deficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-005956-34 Sponsor Protocol Number: 0822-011 Start Date*: 2007-03-14
    Sponsor Name:Merck Sharp & Dohme Ltd
    Full Title: A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0822 in Patients with Osteoarthritis
    Medical condition: Osteoarthritis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10031161 Osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-000558-22 Sponsor Protocol Number: P02538 Start Date*: 2005-06-20
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: Assessment of the safety, efficacy, tolerability and pharmacokinetics of PegIntron plus Rebetol in pediatric patients with chronic hepatitis C.
    Medical condition: Chronic Hepatitis C in pediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003436-21 Sponsor Protocol Number: D2450174 Start Date*: 2005-10-26
    Sponsor Name:Dainippon Sumitomo Pharma Europe Ltd
    Full Title: A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (D...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011008-43 Sponsor Protocol Number: CRAD001AIT16 - EVERHEART Start Date*: 2009-06-24
    Sponsor Name:NOVARTIS FARMA
    Full Title: Early vs.delayed EVERolimus in de novo HEART transplant recipients: optimozation of the safety/efficacy profile (EVERHEART Study)
    Medical condition: de novo heart transplant patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028593 Myocardial disorders HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-013395-48 Sponsor Protocol Number: 1222.27 Start Date*: 2009-11-04
    Sponsor Name:Boehringer Ingelheim RCV GmbH & Co KG
    Full Title: A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalati...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    12.0 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) SI (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2009-014286-20 Sponsor Protocol Number: AGTC-AAT-002 Start Date*: 2010-12-21
    Sponsor Name:Applied Genetic Technologies Corporation
    Full Title: A Multiple-Site, Phase 2, Safety and Efficacy Trial of a Recombinant Adeno-associated Virus Vector Expressing Alpha 1 Antitrypsin (rAAV1-CB-hAAT) in Patients with Alpha 1 Antitrypsin Deficiency
    Medical condition: Alpha 1 antitrypsin deficiency.This is an inherited, genetic condition characterized by reduced serum levels of alpha-1 antitrypsin (AAT) which increases the risk of developing emphysema and liver ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10001806 Alpha-1 anti-trypsin deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    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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