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    The EU Clinical Trials Register currently displays   35504   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004794-41
    Sponsor's Protocol Code Number:Vista
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-004794-41
    A.3Full title of the trial
    Arterial wall inflammation measured with 18F-FDG PET/CT in patients with statin intolerance before and after treatment with a PCSK-9 inhibitor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Arterial wall inflammation measured with 18F-FDG PET/CT in patients with statin intolerance before and after treatment with a PCSK-9 inhibitor
    A.4.1Sponsor's protocol code numberVista
    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 SponsorAcademical medical centre, dep of internal medicine
    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 supportAcademical medical centre, department of internal
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSanofi
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademical medical centre
    B.5.2Functional name of contact pointdepartment of vascular medicine
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-maile.s.stroes@amc.uva.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Alirocumab
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAlirocumab
    D.3.2Product code SAR236553 (REGN727)
    D.3.4Pharmaceutical form Solution and suspension for suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution and suspension for suspension for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with CV-risk and statin intolerance due to statin-associated muscle symptoms (SAMS)
    E.1.1.1Medical condition in easily understood language
    Patients at cardiovascular risk and statin intolerance due to statin-associated muscle symptoms (SAMS)
    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 assess the change in arterial wall inflammation, measured with 18F-FDG PET/CT scan, in patients at increased CV-risk and statin-associated muscle symptoms precluding statin use, before versus after 12 week therapy with Alirocumab 150mg once per 2 weeks subcutaneously.
    E.2.2Secondary objectives of the trial
    1. To determine hematopoietic activity in bone marrow measured by 18F-FDG PET/CT before and after 12 weeks of Alirocumab 150mg once per 2 weeks subcutaneously.
    2. To correlate the activity of arterial wall inflammation and bone marrow measured by 18F-FDG PET/CT with differences in innate immune cell phenotype before and after 12 weeks of Alirocumab 150mg once per 2 weeks subcutaneously.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    • Increased CV-risk
    o Clinical diagnosis of Familial Hypercholesterolemia, OR
    o Previous CV-event, OR
    o Imaging (CT, MRI, Angiography) compatible with atherosclerotic disease, OR
    o (very) high CV risk estimated by risk-engines (Framingham, Score, Procam)
    • Aged 50 years or older
    • Statin-associated Muscle symptoms (SAMS) for at least 3 different statins, precluding statin use
    • LDL-C > 100 mg/dL
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Previous CV-event within 3 months prior to study screening visit
    • Malignant disease in past five years or any medical condition that could interfere with the conduct of the study in the opinion of the investigator.
    • Use of any dose of any statin
    • Chronic or recent (<1 month) infections and/or clinical signs of acute infection
    and/or CRP>10 mg/L
    • Auto-immune diseases
    • Use of chronic immunosuppressant or antibiotics in the last 6 weeks
    • Standard contra-indications to 18F-FDG PET/CT based on physicians experience and current practices
    • Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
    • Participation in a scientific study with radiation exposure in the year prior to inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in 18F-FDG target-to-background ratio (TBR) following 12 weeks of PCSK-9 inhibition.
    E.5.1.1Timepoint(s) of evaluation of this end point
    before and after 3 months of treatment with PCSK9 inhibition or placebo
    E.5.2Secondary end point(s)
    The secondary endpoints are the difference in hematopoietic 18F-FDG activity in bone marrow before and after PCSK-9 inhibition and to evaluate whether there is a correlation between 18F-FDG PET activity in arterial wall and hematopoietic organs (i.e. bone marrow) and circulating immune cell phenotype including but not limited to monocytes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    before and after 3 months of treatment with PCSK9 inhibition or placebo
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 trial2
    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 concerned2
    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 years1
    E.8.9.1In the Member State concerned months0
    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: 50
    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 state50
    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 Decision2017-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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