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Clinical trials for Regulator

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   44335   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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    47 result(s) found for: Regulator. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2006-005331-25 Sponsor Protocol Number: cru001-06 Start Date*: 2007-01-19
    Sponsor Name:Swansea NHS Trust
    Full Title: A study to examine the influence of repaglinide on the 'incretin effect' and oxidative damage associated with postprandial
    Medical condition: Type II Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020014-28 Sponsor Protocol Number: CHDR0905 Start Date*: 2010-05-11
    Sponsor Name:Centre for Human Drug Research
    Full Title: Pharmacokinetics in Plasma and Saliva of a Single Dose Immediate- or Extended Release Methylphenidate in Healthy Volunteers.
    Medical condition: N/A; pharmacokinetic study. Methylphenidate is indicated in ADHD and narcolepsia.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002189-11 Sponsor Protocol Number: VX15-661-112 Start Date*: 2019-05-27
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cyst...
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002579-16 Sponsor Protocol Number: CF001 Start Date*: 2018-08-26
    Sponsor Name:Karolinska University Hospital, Stockholm CF center
    Full Title: Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus sp...
    Medical condition: Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane con...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10074549 Cystic fibrosis respiratory infection suppression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001258-82 Sponsor Protocol Number: CFTRcysta1 Start Date*: 2013-09-12
    Sponsor Name:European Institute for Cystic Fibrosis Research (IERFC)
    Full Title: A phase II pilot clinical study of experimental research to evaluate the functional rescue of CFTR protein through proteostasis regulators
    Medical condition: Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II mutations
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000387-19 Sponsor Protocol Number: VX11-770-110 Start Date*: 2012-06-11
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutation
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000395-97 Sponsor Protocol Number: GS-US-205-0117 Start Date*: 2015-02-02
    Sponsor Name:Gilead Sciences, Inc. [...]
    1. Gilead Sciences, Inc.
    2. Gilead Sciences Pty Ltd
    3. Gilead Sciences Canada, Inc.
    Full Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (A...
    Medical condition: Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004393-10 Sponsor Protocol Number: GN18CA068 Start Date*: 2019-07-17
    Sponsor Name:NHS Greater Glasgow & Clyde [...]
    1. NHS Greater Glasgow & Clyde
    2. University of Glasgow
    Full Title: A randomised, double-blind, placebo-controlled, cross-over trial of zibotentan in microvascular angina
    Medical condition: Microvascular Angina and impaired exercise intolerance.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10065566 Microvascular angina LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-001004-33 Sponsor Protocol Number: VX15-809-115 Start Date*: 2018-01-10
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for t...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001309-34 Sponsor Protocol Number: VX14-809-106 Start Date*: 2017-03-29
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR ...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000673-37 Sponsor Protocol Number: VX12-770-113 Start Date*: 2017-03-27
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 ≥40% Predicted
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001548-13 Sponsor Protocol Number: BRN-C-2015-01 Start Date*: 2015-09-24
    Sponsor Name:BOIRONSIH
    Full Title: RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL TO MEASURE THE EFFICACY OF ACTAEA RACEMOSA (9CH) AND CAULOPHYLLUM THALICTROIDES (9CH) IN THE FIRST STAGE OF LABOR
    Medical condition: First stage of labor
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000131-27 Sponsor Protocol Number: AC17065 Start Date*: 2018-05-23
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: Heme arginate in transplantation - a multi-centre blinded parallel-group randomised trial of heme arginate versus placebo to reduce delayed graft function in kidney transplant recipients. (The HOT ...
    Medical condition: End stage renal disease patients undergoing a deceased donor kidney transplant
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10023438 Kidney transplant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2014-004758-33 Sponsor Protocol Number: Rapid-study Start Date*: 2015-09-08
    Sponsor Name:Medical University of Vienna
    Full Title: Randomized Assessment of patients with clinically suspected Prostate cancer after multiparametric metabolic hybrid Imaging to evaluate its potential clinical Domain: A prospective, randomized, mult...
    Medical condition: Clinical suspected prostate cancer
    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: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004063-21 Sponsor Protocol Number: BVT.BSSL-002 Start Date*: 2008-07-24
    Sponsor Name:Biovitrum AB
    Full Title: An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency.
    Medical condition: Cystic fibrosis and pancreatic insufficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011762 Cystic fibrosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000543-16 Sponsor Protocol Number: VX14-809-109 Start Date*: 2015-06-19
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fib...
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) DK (Completed) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2008-007416-15 Sponsor Protocol Number: VX08-770-102 Start Date*: 2009-08-11
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-000476-18 Sponsor Protocol Number: SPX-CF-001 Start Date*: 2022-05-24
    Sponsor Name:EnBiotix, Inc.
    Full Title: Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aerugin...
    Medical condition: Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Ongoing) SK (Prematurely Ended) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004837-13 Sponsor Protocol Number: VX14-661-106 Start Date*: 2015-06-11
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cy...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed) SE (Completed) GB (Completed) DK (Completed) IT (Completed) NL (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-003967-21 Sponsor Protocol Number: MGT009 Start Date*: 2017-06-09
    Sponsor Name:MeiraGTx UK II Limited
    Full Title: An open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/5-hRKp.RPGR) for gene therapy of adults and children with X-linked Retinitis Pigme...
    Medical condition: X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    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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