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    Summary
    EudraCT Number:2023-000166-33
    Sponsor's Protocol Code Number:SLICK-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-03
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2023-000166-33
    A.3Full title of the trial
    Implementation study of lipid management of high-risk cardiovascular patients- Semmelweis Lipid Center for high-risk patients
    Magas rizikójú kardiovaszkuláris betegek lipid-menedzsmentje- az irányelvek gyakorlatba ültetésének vizsgálata (Semmelweis Lipid Centrum magas rizikójú betegeknek)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Semmelweis Lipid Center for high-risk patients
    Semmelweis Lipid Centrum magas rizikójú betegeknek
    A.3.2Name or abbreviated title of the trial where available
    SLICK
    SLICK
    A.4.1Sponsor's protocol code numberSLICK-001
    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 SponsorSemmelweis University
    B.1.3.4CountryHungary
    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 supportNovartis Hungary Ltd.
    B.4.2CountryHungary
    B.4.1Name of organisation providing supportMinistry of Innovation and Technology
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSemmelweis University
    B.5.2Functional name of contact pointVSZÉK study coordinator
    B.5.3 Address:
    B.5.3.1Street Address68 Városmajor street
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1122
    B.5.3.4CountryHungary
    B.5.6E-mailstudycenter.sekk@gmail.com
    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 Leqvio
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.13.1Other medicinal product type siRNA
    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
    primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in atherosclerotic cardiovascular disease
    primer hiperkoleszterinémia (heterozigóta famailiáris és nem-familiáris) vagy kevert diszlipidémia ateroszklerotikus kardiovaszkuláris betegségben
    E.1.1.1Medical condition in easily understood language
    high LDL-cholesterol level
    magas LDL-koleszterinszint
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054380
    E.1.2Term Familial hypercholesterolemia
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077966
    E.1.2Term Primary hypercholesterolemia
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10079969
    E.1.2Term Atherogenic dyslipidemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show that a dicrease in LDL-level is achievable with establishing a complex, intensive lipid management program.
    Megmutatni, hogy egy komplex, intenzív lipid-menedzsment programmal csökkenés érhető el az LDL-szintben.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of the program in reaching LDL-target and plaque regression.
    Felmérni a program hatékonyságát az LDL célérték elérése és plakk-regresszió tekintetében.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female ≥ 18 years of age at signing of informed consent.
    Written informed consent must be obtained before any assessment is performed.
    Subject agrees to the Maximum dose Statin therapy (Rosuvastatin min. 20 mg or Atorvastatin min. 40 mg)
    Fasting LDL-C local lab value at the Screening Visit ≥ 1.8 mmol/L
    proved atherosclerotic coronary disease (at least 1 of the below): 1) non-obstructive coronary plaques on CT scan in the last 6 months without revascularization, at least in 4 four regions (1-69% stenosis is 2 regions and 25-69% stenosis in 2 other regions); 2)proved acute coronary syndrome in one year with multi-vessel disease (at least 50% stenosis on another artery; post-PCI patient with at least 2 coronary arteries involved
    18 év feletti életkor
    Betegtájékoztató megértése, valamint a beleegyező nyilatkozat elfogadása, aláírása
    LDL szint >1.8 mmol/L ha magas dózisú statin (atorvastatin 40-80mg, vagy rosuvastatin 20-40mg) szedő
    LDL szint >3.3 mmol/L ha statin-näive és ezt követően teljesíti az 1 hónap run-in periódust (magas dózisú statinnal)
    bizonyított coronaria atheroscleroticus megbetegedés (alábbiak közül 1):
    utóbbi 6 hónapban coronaria CT-vel igazolt non-obstruktív coronaria atheroscleroticus plakkok korábbi revaszkularizáció nélkül, legalább 4 régióban (ebből 2 régióban 1-69% stenosis, 2 további régióban 25-69% stenosis)
    igazolt akut koronária szindróma 1 éven belül, több ág betegséggel (legalább 1 másik ág 50% stenosisa)
    korábbi perkután koronária intervención átesett beteg, mely legalább 2 koronária ágat érintett
    E.4Principal exclusion criteria
    Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
    Ongoing malignancy at the time of the first study visit
    Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit.
    Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter must have AST and ALT ≤3x ULN
    Use of other investigational drugs within 5 half-lives of the first study visit (Screening Visit), within 30 days (e.g., small molecules), or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or if required by local regulations. COVID-19 vaccines granted Emergency Use Authorization are not considered investigational drugs for the purpose of this study.
    Heart failure New York Heart Association (NYHA) class IV at the Screening Visit.
    Terhesség, szoptatás, vagy termékeny korúnál nem megfelelő fogamzásgátlás
    aktív malignus betegség
    súlyos krónikus veseelégtelenség (eGFR<30 ml/min/1.73m2)
    aktív májbetegség
    súlyos, tünetes szívelégtelenség (NYHA IV funkcionális stádium)
    korábbi vagy jelenlegi PCSK9- inhibitor terápia
    egyéb klinikai vizsgálatban való aktív részvétel
    egyéb vizsgálati szerrel történt kezelés az utolsó 30 napban vagy az adott szer 5-szörös felezési idején belüli időszakban (amelyik hosszabb)
    E.5 End points
    E.5.1Primary end point(s)
    absolute and percent change in LDL-level from first to last visit (mmol/L)
    absolute and percent LDL-change from visit to visit
    abszolút és százalékos LDL-szint változás 0. és 21. hónap között (mmol/L)
    korrigált LDL abszolút és százalékos változás vizitenként
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last visit (5th), at a mean of 21 months from start
    utolsó vizit (5.), átlagosan 21 hónap a kezdettől
    E.5.2Secondary end point(s)
    change (from first to last visit) in percent of patients reaching LDL target (LDL<1.4 mmol/L)
    teljes plakk volumen változás; ún. „low-attenuation” plakk volumen változás; Agatston score változás; plakk kompozíció változás; perikoronariás és perikardiális zsírszövetmennyiség változása
    Ultrasound (femoral/carotid) endpoints: change in (from first to last visit):
    Total plaque area (mm2)
    Intima:media thickness
    plaque composition
    CCTA endpoints (for those entering with a former CTAA):
    Total plaque volume (mm3)
    Low attenuation plaque volume (%)
    Agatston – score
    plaque composition
    Change in BMI
    Change in lifestyle, diet and health behaviour
    célértéket elérő betegek aránya a 21. hónapban (LDL<1,4 mmol/L)
    coronaria CT vizsgálati karon lévő betegek esetében 0. és 21. havi CT vizsgálatot összehasonlítva: teljes plakk volumen változás; ún. „low-attenuation” plakk volumen változás; Agatston score változás; plakk kompozíció változás; perikoronariás és perikardiális zsírszövetmennyiség változása
    arteria femoralis superficialis ill. arteria carotis communis ultrahang vizsgálat esetében 0. és 21. havi teljes plakk area változás; intima-media vastagság változás; plakk kompozíció változás
    BMI változása
    életmód, diéta, egészség-magatartás változása
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last visit (5th), at a mean of 21 months from start, and from visit to visit (1-3-9-15 months from start)
    utolsó vizit (5.), átlagosan 21 hónap a kezdettől, vizitenként (1-3-9-15 hónap a kezdettől)
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    a képalkotó expertek vakok a klinikai adatokra a mérésekkor
    Imaging experts are blinded to clinical data while assessement
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard ellátás és betegút
    standard care, standard patient pathway
    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
    LVLS
    LVLS-utolsó beteg utolsó vizitje
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state200
    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
    nincs
    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 Decision2023-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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