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    EudraCT Number:2011-001191-19
    Sponsor's Protocol Code Number:2011-400
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-12
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2011-001191-19
    A.3Full title of the trial
    Cardiac effects of inhibition of the renin angiotensin system with losartan in patients with hypertrophic cardiomyopathy.
    Inhibering af renin angiotensin systemet med losartan hos patienter med hypertrofisk kardiomyopati - strukturelle og funktionelle effekter.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects on the heart in patients with hypertophic cardiomyopathy when treated with losartan.
    Effekter på hjertet ved behandling med losartan hos patienter med hypertrofisk kardiomyopati.
    A.4.1Sponsor's protocol code number2011-400
    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 SponsorHjertemedicinsk klinik B, 2142, Rigshospitalet
    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 supportRegion H
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHjertemedicinsk klinik B, 2142, Rigshospitalet
    B.5.2Functional name of contact pointHenning Bundgaard
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityKbh Ø
    B.5.3.3Post code2100
    B.5.4Telephone number+4535450512
    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. name Losartan "Bluefish" 50 mg
    D. of the Marketing Authorisation holderBluefish
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameLosartan
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboTablet
    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
    Hypertrophic cardiomyopathy
    Hypertrofisk kardiomyopati
    E.1.1.1Medical condition in easily understood language
    Hereditary thickening of the heart muscle (hypertrophic cardiomyopathy)
    Arvelig fortykkelse af hjertemuskulaturen (hypertrofisk kardiomyopati)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10020876
    E.1.2Term Hypertrophic obstructive cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find out whether treatment with losartan reduces left ventricular mass in patients with hypertrophic cardiomyopathy.
    At undersøge hvorvidt losartan reducerer venstre ventrikels masse hos patienter med hypertrofisk kardiomyopati.
    E.2.2Secondary objectives of the trial
    To find out whether treatment with losartan
    - reduces myocardial fibrosis
    - increases systolic and diastolic funktion
    - increases work capacity
    - decreases riskfactors for sudden cardiac death
    - decreases arrythmias
    - reduces symptoms of heart failure
    At undersøge hvorvidt losartan
    - reducerer fibrose i myokardiet
    - forbedrer systolisk og diastolisk funktion
    - forbedrer arbejdskapaciteten
    - reducerer risikofaktorer for pludselig hjertedød
    - reducerer antallet af arytmier
    - reducerer symptom på hjertesvigt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Known hypertophic cardiomyopathy
    - > 18 years
    - Sinus rhythm
    - Kendt hypertofisk kardiomyopati
    - > 18 år
    - Sinusrytme
    E.4Principal exclusion criteria
    - Ejection fraction < 50 %
    - Treatment with inhibitor of the renin angiotensin system within 3 months
    - Pregnancy or lactation
    - Renal insufficiency
    - Liver insufficiency
    - Hypotension
    - Not sufficiently treated hypertesnion
    - Earlier experinced angioneurotic oedema when treated with inhibitor of the renin angiotensin system
    - Treatment with Lithium
    - Expected non-compliance
    - Ejection fraction < 50 %
    - Behanling med et præparat der inhiberer renin angiotensin systemet indenfor de sidste tre måneder
    - Graviditet eller amning
    - Nyreinsufficiens
    - Nedsat leverfunktion
    - Hypotension
    - Utilstrækkeligt behandlet hypertension
    - Tidligere angioneutorisk ødem ved behanling med inhibitor af renin angiotensin systemet
    - Behandling med lithium
    - Forventet dårlig compliance

    E.5 End points
    E.5.1Primary end point(s)
    Left ventricular mass
    Venstre ventrikel masse
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 måneder
    E.5.2Secondary end point(s)
    - Thickness of septum
    - Thckness of left ventricles postrior wall
    - Fibrosis of left ventricular wall
    - Gradient in Left ventricular outflow tract
    - Systolic function of left ventricle
    - Diastolic function of left ventricle
    - Left atrial volume
    - Arythmias
    - Work load
    - Blood pressure response
    - Symptoms of heart failure
    - Hypertrophy in ECG
    - NT-pro-BNP
    - Risk factors of sudden cardiac death
    - Selfassessed health and life quality
    - Tolerability
    - Tykkelse af septum
    - Tykkelse af venstre ventrikels bagvæg
    - Fibrose af venstre ventrikels væg
    - Gradient i Left ventricular outflow tract
    - Systolisk funktion af venstre ventrikel
    - Diastolisk funktion af venstre ventrikel
    - Volumen af venstre atrium
    - Arytmier
    - Arbejdskapacitet
    - Blodtryksrespons ved arbejd
    - Symptomer på hjertesvigt
    - Hypertrofi i EKG
    - NT-pro-BNP
    - Risikofaktorer for pludselig død
    - Selvvurderet helbred og livskvalitet
    - Tolerabilitet
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 måneder
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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. 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 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) No
    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 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
    Last visit of the last subject.
    Sidste forsøgspersons sidste besøg.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 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 state320
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-15
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