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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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:2017-005082-47
    Sponsor's Protocol Code Number:HUS/1209/2017
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-03
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-005082-47
    A.3Full title of the trial
    Repolarization study in LQTS patients
    Repolarisaatiotutkimus LQTS potilailla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of electrocardiogram in Long QT syndrome patients
    Sydänsähkökäyrän tutkiminen Pitkä QT -oireyhtymäpotilailla
    A.4.1Sponsor's protocol code numberHUS/1209/2017
    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 SponsorSydän- ja keuhkokeskus, HUS
    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 supportSydän- ja keuhkokeskus, HUS
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSydän- ja keuhkokeskus, HUS
    B.5.2Functional name of contact pointKardiologian poliklinikka
    B.5.3 Address:
    B.5.3.1Street AddressPL 340
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029 HUS
    B.5.3.4CountryFinland
    B.5.6E-mailmikael.koponen@helsinki.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 bisoprololi
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBISOPROLOL
    D.3.9.1CAS number 66722-44-9
    D.3.9.4EV Substance CodeSUB13096MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Long QT syndrome (LQTS) is a hereditary arrhythmia disease. It causes disturbances to the ion flow through cell membranes of cardiomyocytes. These disturbances can sometimes seen in an electrocardiogram (ECG) or 24 hour Holter ECG. LQTS predisposes to cardiac arrhythmia.
    Pitkä QT-oireyhtymä (LQTS) on perinnöllinen rytmihäiriösairaus, johon liittyy äkkikuoleman riski. LQTS:ssa ionivirta kardiomyosyyttien solukalvoilla on häiriintynyt, mikä johtaa sydänfilmissäkin nähtäviin repolarisaation häiriöihin ja rytmihäiriöalttiuteen. Hoitona käytetään mm. beetasalpaajia ja QT-aikaa pidentäviä lääkkeitä tulee välttää.
    E.1.1.1Medical condition in easily understood language
    Long QT syndrome
    Pitkä QT-oireyhtymä
    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
    The objective is to study whether beta-blocker medication stabilizes repolarization in LQT2 patients. Also, the objective is to study repolarization risk factors in high-risk LQTS patients.
    Tutkimuksen tavoitteena on Holter-rekisteröintien repolarisaatioanalyysia käyttäen tutkia beetasalpaajalääkkeen vaikutusta repolarisaation käyttäytymiseen Pitkä QT oireyhtymä tyyppi 2 (LQT2) potilailla, jotta beetasalpaajien merkitys sekä kohdentaminen LQT2-potilailla ymmärrettäisiin paremmin. Tavoitteena on myös löytää keinoja, joilla suuren riskin Pitkä QT -oireyhtymä -potilaat voidaan jatkossa erottaa tehokkaammin pienemmän riskin potilaista vertailemalla elvytettyjen ja ei-elvytettyjen potilaiden sekä terveiden sukulaisten repolarisaatiota. Tulokset voivat edesauttaa aiempaa turvallisemman lääkehoidon ja rytmihäiriöriskiä vähentävien toimien kehittämistä.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-65. Genetically confirmed or excluded LQT1-3.
    Ikä 18-65 vuotta. Geenitestillä varmistettu LQT1, LQT2 tai LQT3 tai geenitestillä poissuljettu LQTS.
    E.4Principal exclusion criteria
    Ikä ei ole 18-65 vuotta. Geenivirheen olemassaolo yksilöllä epävarma.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction or appearance of repolarization abnormalities in Holter recordings.
    EKG-poikkeavuuksien väheneminen beetasalpaajalääkityksen aloittamisen jälkeen Holterissa havaittuna. EKG-poikkeavuudet Holterissa suuren riskin potilailla.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Investigation of Holter recordings,
    Holter-rekisteröintien purku,
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    blinded for statistical analyses
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    not taking beta-blocker (not blinded for study subjects, but blinded for statistical analyses)
    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
    The end of the trial is the Holter recording end of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 120
    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 Yes
    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 state120
    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 Decision2018-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-24
    P. End of Trial
    P.End of Trial StatusOngoing
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