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    Summary
    EudraCT Number:2015-000462-62
    Sponsor's Protocol Code Number:Statex1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-000462-62
    A.3Full title of the trial
    The effects of statins on skeletal muscle mitochondria: is exercise the medicine?
    De effecten van statines op skeletspier mitochondria: is inspanning het medicijn?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The influence of exercise on the energy generating capacity of the mitochondria: could exercise offer a solution?
    de effecten van statine gebruik op het energie gebruik van de skeletspieren: biedt inspanning een oplossing?
    A.3.2Name or abbreviated title of the trial where available
    statins, mitochondria, exercise
    statines, mitochondria, inspanning
    A.4.1Sponsor's protocol code numberStatex1
    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 SponsorRadboud university medical centre
    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 supportRadboud university medical centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud university medical centre
    B.5.2Functional name of contact pointdr. Silvie Timmers
    B.5.3 Address:
    B.5.3.1Street AddressPhilips van Leijdenlaan 15
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525EX
    B.5.3.4CountryNetherlands
    B.5.6E-mailsilvie.timmers@radboudumc.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 Atorvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV
    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.3.4Pharmaceutical form Capsule
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Asymp and symp statin users will undergo baseline measurements of skeletal muscle mitochondrial function and muscle function after which they will be switched to a single-blind placebo intervention for 12 weeks. Then the same measurements will be repeated. Hereafter, only the symptomatic statin users will continue with the intervention en will be randomely allocated to: atorvastatin, atorvastin+exercise or placebo+exercise for another 12 weeks. Then the same measurements will be repeated again.
    E.1.1.1Medical condition in easily understood language
    skeletal muscle side effects of statin use
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    •Do statins accumulate in muscle and cause inhibition of complex III activity of the mitochondrial respiratory chain ?

    •Is the severity of the muscle function decline determined by the total statin concentration in muscle, as well as by the pharmacokinetic properties of the statin?

    •Could aerobic exercise training on top of statin treatment offer protection against statin-associated muscle symptoms by positively influencing muscle metabolism?
    E.2.2Secondary objectives of the trial
    • Can we identify clinically relevant predictive parameters that could facilitate the diagnosis of Statin-associated muscle symptoms in clinical practice (e.g. plasma markers, muscle function, muscle gene expression, whole body energy metabolism)?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age: 18-70 years old
    current statin users
    mentally able/allowed to give informed consent
    E.4Principal exclusion criteria
    familial hypercholesterolemia
    impaired liver function
    hereditary muscle defect
    kidney insufficiency
    unwillingness to abstain from grapefruit juice during the intervention
    E.5 End points
    E.5.1Primary end point(s)
    o Energy generating capacity of muscle mitochondria (in muscle biopsy)
    (see ex vivo measurement in 8.3 study procedures for the detailed biochemical assays that will be carried out in the fresh muscle tissue).
    o Muscle function (= muscle force, contractile speed, relaxation and
    fatigability)
    o Cardiorespiratory fitness (incremental cycling test)
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline (in both symptomatic and asymptomatic statin users);
    at12 weeks: after a 12-week single-blind placebo intervention (in both symptomatic and asymptomatic statin users);
    after 24 weeks: after a subsequent 12 weeks of double-blind randomized intervention with atorvastatin, atorvastatin+exercise or placebo+exercise in symptomatic statin users only
    E.5.2Secondary end point(s)
    o Mitochondrial number (in muscle biopsy)
    o Blood parameters: lipid profile (total cholesterol, HDL-, LDL-cholesterol,
    triglycerides), liver enzymes (ASAT, ALAT, gamma-GT), kidney function (creatinin), creatine kinase, WBC count, pyruvate and lactate
    o Statin concentrations in the muscle and blood
    o Questionnaires on muscle complaints (Short-form McGill pain questionnaire
    and Short-form Brief Pain Inventory)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mitochondrial number: baseline, 12 weeks, 24 weeks
    blood parameters, statin concentrations, questionnaires: every three weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    combination of single blind and double blind intervention
    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.8.2.4Number of treatment arms in the trial4
    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 months
    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: 45
    F.1.3Elderly (>=65 years) No
    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 state45
    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
    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 Decision2015-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-01
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