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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2012-003034-16
    Sponsor's Protocol Code Number:FNOL-IVA-ICD
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-06-28
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2012-003034-16
    A.3Full title of the trial
    Antiarrhythmic and antiremodelation effects of ivabradin in ICD carriers
    Antiarytmické a antiremodelační účinky ivabradinu u nositelů ICD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of the drug ivabradin on decrease of heart rhythm disturbances and against the heart deshaping followed in patients who have been implanted with defibrillator.
    Účinky léku ivabradin na snížení poruch rytmu a znetvoření srdce u pacientů, kteří mají voperovaný defibrilátor.
    A.4.1Sponsor's protocol code numberFNOL-IVA-ICD
    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 SponsorUniversity Hospital Olomouc
    B.1.3.4CountryCzech Republic
    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 supportMinistery of Health
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Olomouc
    B.5.2Functional name of contact pointDirectoriate of University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressI.P.Pavlova 6
    B.5.3.2Town/ cityOlomouc
    B.5.3.3Post code77520
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420588442489
    B.5.6E-mailegon.havrlant@fnol.cz
    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 Procoralan
    D.2.1.1.2Name of the Marketing Authorisation holderServier
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Coated 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 INNIVABRADINE
    D.3.9.1CAS number 155974-00-8
    D.3.9.4EV Substance CodeSUB08357MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 mg to 7,5 mg
    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
    Heart failure
    srdeční selhání
    E.1.1.1Medical condition in easily understood language
    Heart failure
    srdeční selhání
    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
    Decrease in arrhythmia incidence in heart failure patients using ivabradine
    Snížení výskytu arytmií u pacientů se srdečním selháním, užívajících ivabradin
    E.2.2Secondary objectives of the trial
    Antiremodelation effect on left ventricle
    Antiremodelační efekt na levou komoru
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    adults with ICD and EF ≤35% a resting heart rate > 75/min with a standard up-titrated HF treatment (diuretics, verospiron, betablockers, ACEI)
    dospělí pacienti s ICD a EF ≤35% a klidovou sinusovou frekvencí > 75/min se standardní vytitrovanou léčbou diuretiky, ACE inhibitory, betablokátory a verospironem do tolerovaného maxima
    E.4Principal exclusion criteria
    permanent atrial fibrillation, recent (<1 month) myocardial infarction or acute heart failure decompensation, clinically important liver insufficiency, combination with strong CYP3A4 inhibitors, Recent ICD implantation (<1 month). Women in fertile age without proper contraception, pregnant or breastfeeding women. Other concomitant illness which limits prognosis to less then 1 year.
    permanentní fibrilace síní, recentní užívání silných inhibitorů CYP3A4, klinicky významná jaterní insuficience, akutní dekompensace nebo srdeční infarkt v posledním měsíci. Implantace ICD v posledním měsíci. Jiné onemocnění limitující prognózu pacienta na méně než 1 rok. Těhotné anebo ženy ve fertilním věku bez účinné antikoncepce.
    E.5 End points
    E.5.1Primary end point(s)
    Decrease in arrhythmia incidence in the group treated with ivabradine
    Decrease in ICD therapies delivered by ICD
    Snížení incidence supraventrikulárních a ventrikulárních arytmií v intervenované skupině
    Snížení počtu ICD terapií
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months and in 12 months
    po 6 měsících a po 12 měsících
    E.5.2Secondary end point(s)
    Hemodynamical effect of ivabradine evaluated clinically and echocardiographically
    Hemodynamický efekt ivabradinu hodnocený klinicky a echokardiograficky
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6 months and in 12 months
    po 6 měsíích a 12 měsících
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    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 concerned4
    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
    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 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state160
    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
    žádné
    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 Decision2013-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
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