- Trials with a EudraCT protocol (47)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (3)
47 result(s) found for: Regulator.
Displaying page 1 of 3.
| 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... | |||||||||||||
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| 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 | |||||||||||||
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| 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. [...] | ||
| 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 [...] | |||||||||||||
| Full Title: A randomised, double-blind, placebo-controlled, cross-over trial of zibotentan in microvascular angina | |||||||||||||
| Medical condition: Microvascular Angina and impaired exercise intolerance. | |||||||||||||
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| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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 [...] | |||||||||||||
| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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 | |||||||||||||
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| 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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