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Clinical trials for EPA and DHA

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   44334   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 ).  
     
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    22 result(s) found for: EPA and DHA. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-005004-13 Sponsor Protocol Number: NEURAPRO-E FINAL Protocol Start Date*: 2010-10-14
    Sponsor Name:Orygen Research Centre
    Full Title: Add-on Therapie mit Omega-3 Fettsäuren bei Jugendlichen mit hohem Risiko für Schizophrenie und andere psychotische Störungen: eine Multizentren- Replikationsstudie Omega-3 Fatty Acids for Symptomat...
    Medical condition: In view of recent data and after a careful review of potentially neuroprotective treatment options in early psychotic illness, we have decided to replicate the findings of a randomized controlled t...
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004969-41 Sponsor Protocol Number: SPA-S-891/051 Start Date*: 2006-02-14
    Sponsor Name:SOCIETA PRODOTTI ANTIBIOTICI
    Full Title: A double-blind, controlled vs placebo trial to evaluate the efficacy of EPA and DHA ethyl esters, in addition to usual antiarrhythmic therapy, in the manintenance of synus rythm in patients candida...
    Medical condition: Patients with persistent atrial fibrillation candidated to electrical cardioversion.
    Disease: Version SOC Term Classification Code Term Level
    6.1 10003658 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003511-11 Sponsor Protocol Number: D5881C00006 Start Date*: 2015-01-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Two-part, Open-label, Randomised, Crossover, Multicentre, Phase II Study to Investigate the Presence of Pancreatic Exocrine Insufficiency (PEI) in Patients with Type 2 Diabetes Mellitus, and to I...
    Medical condition: Type 2 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    17.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) SE (Completed) DK (Completed) HU (Completed) LV (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-001332-69 Sponsor Protocol Number: PG/04/100/17637 Start Date*: 2005-07-14
    Sponsor Name:University of Aberdeen
    Full Title: A randomised control trial of omega-3 fatty acid on platelet and endothelial function in patients with peripheral arterial disease
    Medical condition: Intermittent claudication
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-003669-18 Sponsor Protocol Number: SVS/K/00604 Start Date*: 2006-11-15
    Sponsor Name:Seven Seas Limited
    Full Title: Efficacy an tolerability of a combinatzion of glucosamine sulphate and the tw omega-3 unsaturated fatty acids EPA and DHA in comparison to glucosamine sulphate in patients with ostearthritis
    Medical condition: Osteoarthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001921-86 Sponsor Protocol Number: S185.4.001 Start Date*: 2007-07-19
    Sponsor Name:Solvay Pharmaceuticals GmbH
    Full Title: A double-blind, placebo-controlled, parallel-group, multi-center study to investigate the effect of Omacor (n-3 PUFA) on lipid parameters in HIV infected patients treated with HAART
    Medical condition: HAART-induced hypertriglyeridemia in HIV infected subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020869 Hypertriglyceridaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-011106-42 Sponsor Protocol Number: 2008MZ09B Start Date*: 2009-06-25
    Sponsor Name:Institute for Clinical and Experimental Medicine
    Full Title: Aditive effects of omega-3 polyunsaturated fatty acids and pioglitazone in the treatment of type 2 diabetes mellitus
    Medical condition: The project deals with hummoral and metabolic aspects of insulin resistance (IR), which is assumed to be the basic metabolic disorder which leads to the development of type 2 diabetes mellitus (T2D...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001249-41 Sponsor Protocol Number: KEK-ZH-2012-0249 Start Date*: 2013-04-12
    Sponsor Name:University Hospital of Zurich and City Hospital Waid
    Full Title: Vitamin D3 – Omega3 – Home Exercise – HeALTHy Ageing and Longevity Trial Randomized, double-blind, placebo-controlled, multi-centre clinical trial
    Medical condition: healthy ageing, functional decline
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) PT (Completed) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-018054-33 Sponsor Protocol Number: 09-001 Start Date*: 2010-06-21
    Sponsor Name:Faculty of Pharmacy, University of Ljubljana
    Full Title: Efficacy of vitamin E and omega-3 unsaturated fatty acid in prevention of damage induced by oxidative stress in patients with schizophrenia
    Medical condition: Patients diagnosed with schizophrenia chronically treated with depo haloperidol will be randomly assigned to four arms; i) placebo, ii) vitamin E (1200 IU/day), iii) omega-3 (360 mg/day EPA, 240 mg...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10039626 Schizophrenia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2007-005582-36 Sponsor Protocol Number: SIM-07-003 Start Date*: 2008-04-07
    Sponsor Name:DEFIANTE FARMACEUTICA,LDA
    Full Title: A RANDOMIZED MULTICENTRE PHASE II STUDY TESTING TOLERABILITY AND EFFICACY ON SURROGATE ENDPOINTS (LIPID PROFILE, VASCULAR INFLAMMATORY MARKERS AND THROMBOGENESIS) OF SIMVAPUFA FORMULATION (ASSOCIAT...
    Medical condition: For this study, patients with acute coronary syndrome STEMI (ST-Elevation Myocardial Infarction and NSTEMI (Non-ST-Elevation Myocardial Infarction), occurred within the previous 72 hours with posit...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004949-41 Sponsor Protocol Number: 1241 Start Date*: 2007-09-11
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: RANDOMIZED DOUBLE-BLIND STUDY TO EVALUATE THE ADJUVANT EFFECT OF POLYNSATURED FATTY ACIDS OMEGA-3 IN THERAPY WITH S.S.R.I. PAROXETINE MESYLATE IN UNIPOLAR MOOD DEPRESSION AND RECURRENT DEPRESSION
    Medical condition: Mood depression
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012374 Depressed mood LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024064-18 Sponsor Protocol Number: OM-EPA-003 Start Date*: 2011-03-22
    Sponsor Name:Omthera Pharmaceutical Inc.
    Full Title: Efficacy and Safety of Epanova® in Severe Hypertriglyceridemia
    Medical condition: Severe hypertriglyceridemia defined as serum triglyceride (TG) values ≥500 and <2000 mg/dL (≥5.65 mmol/L and <22.60 mmol/L).
    Disease: Version SOC Term Classification Code Term Level
    12.1 10020870 Hypertriglyceridemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-003503-39 Sponsor Protocol Number: ABR54654 Start Date*: 2016-07-27
    Sponsor Name:University Medical Center Utrecht
    Full Title: Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
    Medical condition: Individuals at Ultra High Risk for Psychosis
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) AT (Completed) IT (Completed) ES (Ongoing) DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2009-014869-43 Sponsor Protocol Number: 2008_47/0928 Start Date*: 2009-12-21
    Sponsor Name:Centre Hospitalier Régional et Universitaire
    Full Title: Influence des acides gras polyinsaturés à longue chaîne n-3 sur l'expression des mucines dans la muqueuse nasale de patients atteints de mucoviscidose
    Medical condition: Mucoviscidose
    Disease: Version SOC Term Classification Code Term Level
    12.0 10028141 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003633-33 Sponsor Protocol Number: MAXEPA01 Start Date*: 2011-09-29
    Sponsor Name:Central Manchester University Hospitals NHS Foundation Trust
    Full Title: The effect of purified fish oils on glucose regulation in Congenital Hyperinsulinism of Infancy (CHI)
    Medical condition: Congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10062329 Congenital endocrine anomaly PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-003147-19 Sponsor Protocol Number: BECRO/MINERALstudy Start Date*: 2016-07-18
    Sponsor Name:PALUPA Medical Ltd
    Full Title: Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Cont...
    Medical condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003397-82 Sponsor Protocol Number: HC-G-H-0813 Start Date*: 2012-12-12
    Sponsor Name:B. Braun Melsungen AG
    Full Title: Prospective, randomized, controlled, double-blind, parallel-group, mono-centre, explorative Phase IV trial on the efficacy and safety of a fish oil containing lipid emulsion versus a standard soybe...
    Medical condition: Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10069351 Acute lung injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003514-24 Sponsor Protocol Number: OLEV01/2015 Start Date*: 2016-07-15
    Sponsor Name:IBSA FARMACEUTICI ITALIA SRL
    Full Title: Phase III study, double blind, placebo controlled, to evaluate the efficacy and the safety of an omega-3 based drug, in patients with primary tinnitus.
    Medical condition: Primary tinnitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004682-14 Sponsor Protocol Number: OM-EPA-011 Start Date*: 2014-04-15
    Sponsor Name:Omthera Pharmaceuticals, Inc.
    Full Title: A 12-Week, Randomized, Double-Blind, Olive Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of EPANOVA™ in Subjects With Severe Hypertriglyceridemia (EVOLVE II)
    Medical condition: Severe hypertriglyceridemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004861 10020870 Hypertriglyceridemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) NL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-000641-13 Sponsor Protocol Number: BIO89-100-221 Start Date*: 2020-09-30
    Sponsor Name:89bio, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects with Severe Hypertriglyceridemia
    Medical condition: Severe Hypertriglyceridemia (SHTG)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10020870 Hypertriglyceridemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) PL (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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