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    Summary
    EudraCT Number:2012-003029-11
    Sponsor's Protocol Code Number:2012-489
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-003029-11
    A.3Full title of the trial
    Ethyl ester Versus Triglyceride formulations of long chained omega-3 fatty acids in moderate hypertriglyceridemia - a randomized placebo-controlled clinical trial (EVT)
    Et dobbelt-blindt, placebo-kontrolleret, interventionsforsøg, der sammenligner den triglycerid-nedsættelnde effekt af n-3 flerumættede fedtsyrer (n-3 PUFA), som etylester og som acylglyceroler hos patienter med moderat ikke fastende hypertriglyceridæmi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo-controlled, intervention trial comparing the triglyceride-lowering effect of omega-3 polyunsaturated fatty acids, as either ethyl ester or triglycerides in patients with moderately elevated triglyceride levels in the blood in non fasting state.
    Et dobbelt-blindt, placebo kontrolleret, interventionsforsøg, der sammenligner den triglycerid-nedsættende effekt af omega-3 flerumættede fedtsyrer, som etylester og som triglycerider hos patienter med moderat forhøjet triglycerid i blodet i ikke fastende tilstand.
    A.3.2Name or abbreviated title of the trial where available
    EVT
    EVT
    A.4.1Sponsor's protocol code number2012-489
    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 SponsorSteen Stender
    B.1.3.4CountryDenmark
    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 supportMarine Ingredients
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMetagenics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGentofe University Hospital
    B.5.2Functional name of contact pointDepartment of Clinical Biochemistry
    B.5.3 Address:
    B.5.3.1Street AddressNiels Andersens Vej 65
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number4539773120
    B.5.5Fax number4539978193
    B.5.6E-mailsteen.stender@regionh.dk
    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 Omacor
    D.2.1.1.2Name of the Marketing Authorisation holderPronova BioPharma ASA
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEICOSAPENTAENOIC ACID ETHYL ESTER
    D.3.9.1CAS number 73310-10-8
    D.3.9.3Other descriptive nameEICOSAPENTAENOIC ACID ETHYL ESTER
    D.3.9.4EV Substance CodeSUB32403
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number463
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCOSAHEXANOIC ACID
    D.3.9.1CAS number 8000046-93-7
    D.3.9.3Other descriptive nameDOCOSAHEXANOIC ACID
    D.3.9.4EV Substance CodeSUB13642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertriglyceridemia
    Hypertriglyceridæmi
    E.1.1.1Medical condition in easily understood language
    Increased triglyceride in the blood of nonfasting subjects
    Forhøjet triclycerid i blodet hos ikke fastende personer
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10071235
    E.1.2Term Combined hyperlipidemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10060754
    E.1.2Term Type IV hyperlipidemia
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A comparison of the triglyceride lowering effect, in th non-fasting state of the prescription drug Lovaza/Omacor given in the approved dose of 4 g/day (1,860 mgEPA + 1,500 mg DHA in the ethyl ester form) to that of a non-presription
    E.2.2Secondary objectives of the trial
    Any alteration in efficacy tests No. 2 - 15.
    2. P-total cholesterol (TC)
    3. P-LDL-cholesterol (LDL-C)
    4. P-HDL-cholesterol (HDL-C)
    5. TC: HDL-C ratio
    6. LDL-C:HDL-C ratio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women, > 18 years of age.
    2. Hypertriglyceridemia with non-fasting plasma triclyceride 2.0 - 5.65 mmol/l (177 - 500 mg/dl) prior to enrolment
    3. Body mass index (BMI) > 18 kg/m2 and < 35 kg/m2.
    E.4Principal exclusion criteria
    1. Poorly regulated diabetes mellitus
    2. Alcohol abuse (more than 3 drinks/day)
    3. Drug abuse
    4. Participation in lipid lowering studies later than 4 weeks before
    E.5 End points
    E.5.1Primary end point(s)
    1. Alteration in non-fasting plasma triglycerides concentration from study-start to study-end group 1-2, as comparet to the placebo group (group 3)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Eight weeks for all primary endpoints
    E.5.2Secondary end point(s)
    1. Any alteration in efficacy tests No. 2-15.
    2. Correlation between changes in the omega-3 index, TG, and other efficacy tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    Eight weeks for all secondary endpoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state120
    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)
    Participants are informed on triglycerid lowering lifestyle changes. If end of study triglyceride level exceeds 5 mmol/L the subject is advised to seek medical care at the GP
    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 Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-22
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