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    Summary
    EudraCT Number:2013-004342-42
    Sponsor's Protocol Code Number:201302
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-004342-42
    A.3Full title of the trial
    The effect of fish oil supplements on hemorheological parameters and walking distance in patients with intermittent claudication
    Het effect van visolie supplementen op hemorheoligische factoren en loopafstand bij patienten met claudicatio intermittens
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of fish oil on red blood cell function and walking distance in patients with arterial occlusion in the legs
    Het effect van visolie op de functie van de rode bloedcel en de loopafstand bij patienten met vaatvernauwing in de benen
    A.3.2Name or abbreviated title of the trial where available
    FISHTIC
    FISHTIC
    A.4.1Sponsor's protocol code number201302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedisch Centrum Alkmaar
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedisch Centrum Alkmaar
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedisch Centrum Alkmaar
    B.5.2Functional name of contact pointAlexander Houdijk
    B.5.3 Address:
    B.5.3.1Street AddressWilhelminalaan 12
    B.5.3.2Town/ cityAlkmaar
    B.5.3.3Post code1815JD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031725484444
    B.5.5Fax number0031725482422
    B.5.6E-maila.p.j.houdijk@mca.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Omega-3 fatty acid ethylesthers
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOmega-3 fatty acid ethylesthers
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients suffering from intermittent claudication
    Patienten die lijden aan claudicatio intermittens
    E.1.1.1Medical condition in easily understood language
    Patients suffering from arterial occlusion in the legs
    Patienten die lijden aan vaatvernauwing in de benen
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10067825
    E.1.2Term Peripheral arterial disease
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of omega-3 fatty acids on maximal walking distance in patients with intermittent claudication (IC) receiving supervised exercise therapy (SET) compared to patients with IC receiving SET alone.
    Het effect van omega-3 vetzuren onderzoeken op maximale loopafstand in patienten met claudicatio intermittens die behandeld worden met gesuperviseerde looptraining vergeleken met patienten met claudicatio intermittens die alleen gesuperviseerde looptraining krijgen.
    E.2.2Secondary objectives of the trial
    To study the effect of supplementation of omega-3 fatty acids during 4 weeks on:
    - Hemorheological parameters: blood and plasma viscosity, hematocrit and erythrocyte deformability and aggregation
    - Pain free walking distance
    -Ankle Brachial Index
    -- Blood values (Hemoglobin, leucocytes, CRP, total-, HDL- and LDLcholesterol,
    triglycerides)-Blood pressure and heart rate
    -Walking impairment measured by questionnaire
    - ex vivo cytokine production of IL-6, IL-10 and TNF-alpha of whole
    blood stimulated with LPS
    - Erythrocyte membrane fatty acid composition
    - Visceral fat mass

    To compare treatment with SET and omega-3 fatty acids to treatment with SET alone by determining the above metioned parameters.
    Het effect bestuderen op supplementatie van omega-3 vetzuren
    gedurende vier weken op:
    -Hemorheolgische parameters: bloed en plasma viscositeit, hematocriet,
    erythrocyt deformabiliteit en aggregatie
    -Pijn vrije loopafstand
    -Enkel arm index
    -Andere bloedwaardes: hemoglobine, leukocyten, CRP, totaal cholesterol, HDL, LDL, triglycerides
    -Bloeddruk, hartfrequentie
    -Beperkingen in lopen, gemeten door middel van een vragenlijst
    - ex vivo volbloed cytokine prodcutie van IL-6, TNF-alfa, IL-10 na LPS
    - viscerale vetmassa
    - erytrocytenmembraan vetzuursamenstelling
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age ≥ 18
    •Newly diagnosed intermittent claudication
    •Ankle Brachial Index < 0.8 at rest or > 0.15 decrease after exercise
    •Able to perform standardized treadmill walking test for 2 min
    •Written informed consent
    •Leeftijd ≥ 18
    •Nieuw gediagnosticeerde claudicatio intermittens
    •Enkel arm index < 0.8 bij rust of >0.15 afname bij inspanning
    •Mogelijkheid om gestandaardiseerde looptest te doen gedurende 2 min
    •Geschreven informed consent
    E.4Principal exclusion criteria
    •Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language)
    •Heart failure or unstable cardiac status (angina pectoris NYHA class III or IV or recent myocardial infarction < 3 months)
    •Any illness with rapid evolution or a life expectancy < 3 months
    •Recent cerebrovascular accident (< 3 months)
    •Current use of fish oil supplements or > 2 times a week dietary fish
    •Pregnancy
    •Fish, soybean or peanut allergy
    •Contra indications for the use of omega-3 fatty acids
    - use of oral anticoagulants (coumarin derivatives)
    •Geen mogelijkheid om een vragenlijst in te vullen
    •Hartfalen of instabiele cardiale status (angina pectoris NYHA klasse III of IV of recent hartinfarct binnen 3 maanden)
    •Elke ziekte met een snelle progressie of levensverwachting < 3 mnd
    •Recent herseninfarct <3 mnd
    •Gebruik van visolie supplementen of meer dan 2 keer per week visconsumptie
    •Zwangerschap
    •Allergie voor sojabonen, pinda's
    •Contra indicaties voor het gebruik van omega-3 vetzuren
    - gebruik van orale antistolling (coumarinederivaten)
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameter is the change in maximal walking distance after 12 weeks of exercise therapy.
    Het primaire eindpunt is de verandering in maximale loopafstand na 12 weken gesuperviseerde looptraining
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 weken
    E.5.2Secondary end point(s)
    •Hemorheological parameters: blood and plasma viscosity, hematocrit and erythrocyte deformability and aggregation
    •Pain free walking distance
    •Maximal walking distance
    •Ankle Brachial Index
    •Other laboratory measures: hemoglobin, leucocytes, CRP, total-, LDL-, and HDL cholesterol, triglycerides
    •Blood pressure and heart rate
    •Walking impairment measured by questionnaire
    - erythrocyte membrane fatty acid composition
    - ex vivo LPS stimulated whole blood cytokine production
    - visceral fat mass
    -Hemorheolgische parameters: bloed en plasma viscositeit, hematocriet, erythrocyt deformabiliteit en aggregatie
    -Pijn vrije loopafstand
    -Enkel arm index
    -Andere bloedwaardes: totaal cholesterol, HDL, LDL, triglycerides
    -Bloeddruk, hartfrequentie
    -Beperkingen in lopen, gemeten door middel van een vragenlijst
    - erytrocytenmembraan vetzuursamenstelling
    - ex vivo LPS gestimuleerde volbloed cytokine productie
    - viscerale vetmassa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Intervention group: baseline, 4 weeks, 10 weeks, 16 weeks
    Control group: baseline, 6 weeks, 12 weeks
    Interventie groep: uitgangssituatie, 4 weken, 10 weken, 16 weken
    Controle groep: uitgangssituatie, 6 weken, 12 weken
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standaard behandeling
    standard treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined after 12 weeks of supervised exercise therapy and the last tests at this timepoint.
    Het einde van de studie is gedefinieerd na 12 weken gesuperviseerde looptraining en als ook de testen zijn verricht.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state136
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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