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    Summary
    EudraCT Number:2017-002898-19
    Sponsor's Protocol Code Number:IndiviStat#1
    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:2017-12-19
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-002898-19
    A.3Full title of the trial
    There is no English name for the trial.
    IndiviStat#1-tutkimus: Perinnöllisten ja muiden yksilötekijöiden vaikutus statiinilääkehoitoon
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    There is no English name for the trial.
    IndiviStat#1-tutkimus: Perinnöllisten ja muiden yksilötekijöiden vaikutus statiinilääkehoitoon
    A.4.1Sponsor's protocol code numberIndiviStat#1
    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 SponsorHelsinki University Central Hospital
    B.1.3.4CountryFinland
    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 supportEuropean Research Council, European Commission
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Central Hospital
    B.5.2Functional name of contact pointDepartment of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressTukholmankatu 8C
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.6E-mailmikko.niemi@hus.fi
    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 The products to be administered as IMPs are defined as belonging to an ATC group
    D.2.1.1.2Name of the Marketing Authorisation holderMarketing authorisation holder is not fixed
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 Tablet
    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 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 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
    Primary prevention of atherosclerotic disease
    E.1.1.1Medical condition in easily understood language
    Primary prevention of atherosclerotic disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effects of genetic variants and other individual factors on statin efficacy, tolerability and concentrations in patients starting a new statin treatment
    Tämän tutkimuksen tavoitteena on tutkia miten geenimuunnokset ja muut yksilölliset tekijät vaikuttavat statiinien tehoon, siedettävyyteen ja pitoisuuksiin potilailla, jotka aloittavat uuden statiinilääkityksen

    E.2.2Secondary objectives of the trial
    To investigate the effect of statin therapy on the levels of metabolism-derived products in patients starting a new statin treatment
    Tutkia miten statiinilääkitys vaikuttaa aineenvaihduntatuotteiden pitoisuuksiin potilailla, jotka aloittavat uuden statiinilääkityksen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • a signed informed consent,
    • age ≥18 years,
    • an indication for statin treatment in agreement with Finnish standard treatment guidelines ("käypä hoito"),
    • a new statin prescription for primary prevention of atherosclerosis
    • allekirjoitettu tietoinen suostumus,
    • ikä ≥18 vuotta,
    • käypä hoito -suosituksen mukainen indikaatio statiinihoidolle,
    • uusi statiinilääkitys ateroskleroottisen sairauden primaaripreventioon
    E.4Principal exclusion criteria
    • a person as defined in sections 7-10§ of the Finnish law on Medical Research (disabled, underage, pregnant, nursing or prisoner),
    • a contraindication for statin treatment
    • ”lain lääketieteellisestä tutkimuksesta” 7-10§:ssä tarkoitettu henkilö (vajaakykyinen, alaikäinen, raskaana oleva, imettävä tai vanki),
    • vasta-aihe statiinilääkitykselle
    E.5 End points
    E.5.1Primary end point(s)
    • % change in LDL cholesterol levels (ΔLDL%),
    • statin intolerance
    • LDL-kolesterolipitoisuuden %-muutos (ΔLDL%),
    • statiini-intoleranssi
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 and 12 months
    1 ja 12 kk
    E.5.2Secondary end point(s)
    • adherance
    • plasma concentrations of statins, their metabolites, and endogenous and nutrition-derived metabolites
    • adherenssi
    • statiinien ja niiden aineenvaihduntatuotteiden sekä endogeenisten ja ravintoperäisten aineenvaihduntatuotteiden plasmapitoisuudet
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 12 months
    1 ja 12 kk
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    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
    Prospektiivinen havainnoiva kliininen tutkimus
    Prospective observational clinical trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    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, otherwise approximately 12 months after enrollment of last subject.
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-12-19. Yes
    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 state500
    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)
    This is an observational trial. The trial will not interfere with patient treatment or care.
    Kyseessä on havainnoiva tutkimus. Tutkimuksessa ei puututa potilaiden lääkehoitoon tai muuhun hoitoon.
    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 Decision2018-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-03
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