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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Summary
    EudraCT Number:2009-010520-25
    Sponsor's Protocol Code Number:AMR-01-01-0016
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-09
    Trial results View 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 ConcernedFinland - Fimea
    A.2EudraCT number2009-010520-25
    A.3Full title of the trial
    A Phase 3, Multi-Center, Placebo-Controlled, Randomized,
    Double-Blind, 12-Week Study With an Open-Label Extension
    to Evaluate the Efficacy and Safety of AMR101 in Patients
    With Fasting Triglyceride Levels ≥500 mg/dL and ≤2000 mg/dL:
    The AMR101 MARINE Study
    A.3.2Name or abbreviated title of the trial where available
    The Marine Study
    A.4.1Sponsor's protocol code numberAMR-01-01-0016
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmarin Pharma Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameEthyl-Eicosapentaenoate [Ethyl-EPA])
    D.3.2Product code AMR101
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNETHYL EICOSAPENTAENOATE
    D.3.9.1CAS number 73310108
    D.3.9.2Current sponsor codeEthyl-EPA
    D.3.9.3Other descriptive nameEPA-E
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10014486
    E.1.2Term Elevated triglycerides
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020870
    E.1.2Term Hypertriglyceridemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the efficacy of AMR101 2 g daily and 4 g daily, compared to placebo, in lowering fasting TG levels in patients with fasting TG levels >=500 mg/dL and <=2000 mg/dL (>=5.6 mmol/L and <=22.6 mmol/L).
    E.2.2Secondary objectives of the trial
    The secondary and exploratory objectives to determine:
    1. Safety and tolerability of AMR101 2 g daily and 4 g daily;
    2. Effect of AMR101 on lipid profiles, including TC, non-HDL-C, LDL-C, HDL-C and VLDL-C;
    3. Effect of AMR101 on VLDL TG;
    4. Effect of AMR101 on apo A-I, apo B, apo A-I/apo B ratio, Lp[a], and Lp-PLA2;
    5. Effect of AMR101 on LDL particle number and size;
    6. Effect of AMR101 on oxidized LDL and RLP-C;
    7. Effect of AMR101 on FPG and HbA1c;
    8. Effect of AMR101 on insulin resistance;
    9. Effect of AMR101 on hsCRP;
    10. Effect of AMR101 on ICAM-1, IL-6, and PAI-1;
    11. Effects of AMR101 on fatty acid concentrations including [EPA] in plasma and in red blood cell membranes;
    12. To explore the relationship between baseline fasting TG levels and the reduction in fasting TG levels;
    13. To explore the relationship between changes in fatty acid concentrations (including EPA) in plasma and red blood cell membranes and the reduction in fasting TG levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Understanding of the study procedures, willing to adhere to the study
    schedules, and agreement to participate in the study by giving written
    informed consent prior to screening (Visit 1 [Week -8 or Week -6]);
    2. Men or women >18 years of age;
    • Women may be enrolled if all 3 of the following criteria are met:
    - They are not pregnant,
    - They are not breastfeeding, and
    - They do not plan on becoming pregnant during the study;
    • Women of childbearing potential must have a negative serum pregnancy test at screening (Visit 1 [Week -8 or Week -6]). Note: Women are not considered to be of childbearing potential if they meet 1 of the following criteria as documented by the investigator:
    - They have had a hysterectomy or tubal ligation prior to signing the informed consent form or
    - They are post-menopausal, defined as >=1 year since their last menstrual period or have a follicle-stimulating hormone (FSH) level in a menopausal range;
    • Women of childbearing potential must agree to use an effective method of avoiding pregnancy from screening to the end of the study, including 9 days after the last dose of study drug, unless their sexual partner is surgically sterile or they are abstinent. Effective methods of avoiding pregnancy are contraceptive methods used consistently and correctly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap). Women of childbearing potential in Denmark cannot use abstinence as a method of avoiding pregnancy and must use one or more of the listed contraceptive methods even if their partner is surgically sterile;
    3. Not on lipid-altering therapy at screening or on 1 of the following lipid altering treatment regimens at screening;
    • On statin therapy (with or without ezetimibe). Patients currently on statin therapy (with or without ezetimibe) will be evaluated by the investigator as to whether this therapy can be safely discontinued at screening, or if it should be continued. For the criteria of safe withdrawal of statin therapy at screening, see Appendix B. If statin therapy (with or without ezetimibe) is to be continued, dose(s) must be stable for >=4 weeks prior to the TG baseline qualifying measurements for randomization (i.e., Visit 2 [Week -2]) or
    • On non-statin, lipid-altering medications (niacin >200 mg/day, fibrates, fish oil, other products containing omega-3 fatty acids, or other herbal products or dietary supplements with potential lipid altering effects), either alone or in combination with statin therapy (with or without ezetimibe). Patients currently taking these non-statin, lipid-altering medications must be able to safely discontinue all non-statin, lipid altering therapy at screening. For the criteria of safe withdrawal of non-statin, lipid-altering medications at screening, see Appendix B;
    4. Triglyceride levels >=500 mg/dL and <=2000 mg/dL (>=5.6 mmol/L and <=22.6 mmol/L) (based on an average [arithmetic mean] of Visit 2 [Week -2] and Visit 3 [Week -1]). Note: In cases in which a patient’s average TG level from Visit 2 and Visit 3 falls outside the required range for entry into the study, an additional sample for fasting TG measurement can be collected 1 week later at Visit 3.1. If a third sample is collected at Visit 3.1, entry into the study will be based on the average (arithmetic mean) of the values from Visit 3 and Visit 3.1.; and
    5. Willingness to maintain stable diet and physical activity level throughout the study.
    E.4Principal exclusion criteria
    1. Body mass index >45 kg/m2;
    2. Participation in another clinical trial involving an investigational agent within 30 days prior to screening (Visit 1 [Week -8 or Week -6]);
    3. Weight change >3 kg between screening (Visit 1 [Week -8 or Week -6]) and Visit 2 (Week -2);
    4. HbA1c >9.5% at screening (Visit 1 [Week -8 or Week -6]);
    5. Use after Visit 1 (Week -8 or Week -6) and during the double-blind period of the study (up to Visit 7 [Week 12]) of any non-study, non statin, lipid-altering medications or supplements including:
    • Niacin >200 mg/day;
    • Fibrates;
    • Omega-3 fatty acid medications;
    • Supplements (e.g., flaxseed, fish, or algal oils) or foods enriched with omega-3 fatty acids (consumption of up to 2 servings per week of fish is acceptable);
    • Sterol/stanol products;
    • Dietary fiber supplements, including >2 teaspoons of Metamucil or psyllium-containing supplements per day;
    • Red yeast rice supplements, garlic supplements, or soy isoflavones supplements;
    • Any other medications, herbal products, or dietary supplements with known or potential lipid-altering effects;
    6. History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within 6 months prior to screening;
    7. History of acute or chronic pancreatitis;
    8. History of symptomatic gallstone disease unless treated with cholecystectomy;
    9. Known nephrotic range (>3 g/day) proteinuria;
    10. History or evidence of major and clinically significant, hepatic, pulmonary, renal, hematologic, gastrointestinal (including clinically significant malabsorption), endocrine (other than type 1 or type 2 diabetes), immunologic, dermatologic, neurologic, psychiatric, oncologic, or allergic (including drug allergies, but excluding untreated or treated seasonal allergies at the time of dosing) disease that would interfere with the conduct of the study or interpretation of the data;
    11. Known familial lipoprotein lipase impairment or deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III);
    12. Requirement for peritoneal dialysis or hemodialysis for renal insufficiency;
    13. History of malignancy, except patients who have been disease-free for >5 years, or whose only malignancy has been basal or squamous cell skin carcinoma;
    14. History of bariatric surgery;
    15. Uncontrolled hypertension: sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg;
    16. Known to be infected with human immunodeficiency virus (HIV);
    17. Positive test for hepatitis B surface antigen or hepatitis C antibody at screening (Visit 1 [Week -8 or Week -6]);
    18. Anticipation of major surgery during the screening or double-blind periods of the study;
    19. Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification (e.g., antihypertensive and antidiabetic medications) that has not been stable for >=4 weeks prior to screening;
    20. Ongoing treatment with weight loss drugs (including over the counter);
    21. Ongoing treatment with HIV-protease inhibitors, cyclophosphamide, or isotretinoin;
    22. Treatment with tamoxifen, estrogens, or progestins that has not been stable for >=4 weeks prior to screening;
    23. Routine or anticipated use of all systemic corticosteroids. Use of local, topical, inhalation or nasal corticosteroids is permitted;
    24. Thyroid-stimulating hormone (TSH) >1.5 x upper limit of normal (ULN), clinical evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for >=6 weeks prior to screening;
    25. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x ULN;
    26. Unexplained creatine kinase concentration >3 × ULN or creatine kinase elevation due to known muscle disease (e.g., polymyositis, mitochondrial dysfunction);
    27. Blood donation of >=1 pint (0.5 L) within 30 days prior to screening, or plasma donation within 7 days prior to screening (Visit 1 [Week -8 or Week -6]);
    28. Consumption of >2 alcoholic beverages per day following screening (any time during the study after Visit 1 [Week -8 or Week -6]);
    29. History of illicit drug use within 1 year of screening (before Visit 1 [Week -8 or Week -6]);
    23. Any condition or therapy, which, in the opinion of the investigator, might pose a risk to the patient or make participation in the study not in the patient’s best interest; or
    31. Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study (Visit 1 [Week -8 or Week -6]).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for the double-blind treatment period is percent change in TG from baseline to Week 12 endpoint
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    12 week double-blind followed by 40 week open label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 240
    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 Decision2009-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-19
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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
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