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    Summary
    EudraCT Number:2013-000189-12
    Sponsor's Protocol Code Number:ABR43234
    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:2013-03-08
    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 number2013-000189-12
    A.3Full title of the trial
    Effects of the selective mineralocorticoid receptor antagonist eplerenone on extracellular formation of adenosine
    De effecten van de selectieve mineralocorticoid receptorantagonist eplerenone op de extracellulaire vorming van adenosine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of eplerenone on forearm blood flow
    De effecten van eplerenone op de bloeddoorstroming in de onderarm
    A.3.2Name or abbreviated title of the trial where available
    eplerenone and adenosine
    eplerenon en adenosine
    A.4.1Sponsor's protocol code numberABR43234
    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 Medical Centre Nijmegen
    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 supportUniversity Medical Centre Nijmegen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Nijmegen
    B.5.2Functional name of contact pointDep. of Farmacology-toxicology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 21
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525EZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243613691
    B.5.5Fax number0031243614214
    B.5.6E-mailD.Berg@aig.umcn.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 Inspra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeplerenone
    D.3.9.3Other descriptive nameEPLERENONE
    D.3.9.4EV Substance CodeSUB06574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    healthy volunteers
    gezonde vrijwilligers
    E.1.1.1Medical condition in easily understood language
    healthy volunteers
    gezonde vrijwilligers
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    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 study whether the mineralocorticoid receptor antagonist eplerenone activates CD73 and hereby increases extracellular formation of adenosine in humans in vivo, by using the forearm vasodilator respons to the intrabrachial administration of the ENT-inhibitor dipyridamole, as a surrogate for adenosine stimulation
    Het belangrijkste doel is te onderzoeken of de mineralocorticoid receptorantagonist eplerenon CD73 activeert en hierdoor zorgt voor een toename van de extracellulaire vorming van adenosine bij gezonde vrijwilligers. Om dit te onderzoeken wordt de respons van dipyridamol op de bloeddoorstroming in de onderarm gebruikt. Dipyridamol dient als een surrogaat voor adenosevorming.
    E.2.2Secondary objectives of the trial
    The effect of eplerenone on the forearm vasodilator response to arterial occlusion (post occlusive reactive hyperemia)
    Het verschil in bloeddoorstroming in de onderarm na arteriële occlusie (post occlusive reactive hyperemia) tussen eplerenon en placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    male sex, age 18-40 years, healthy, written informed consent
    mannelijk geslacht, leeftijd 18-40 jaar, gezond, verkregen en geschreven informed consent
    E.4Principal exclusion criteria
    potassium >4.8 mmol/L, smoking, hypertension (SBP >140 or DBP >90 mmHg), hypotension (SBP <100 or DBP <60 mmHg), diabetes mellitus (fasting glucose >7.0 mmol/L or random >11.0 mmol/L), history of any cardiovascular disease, angina pectoris, history of COPD or asthma, alcohol and/or drug abuse, concomitant use of medication, renal dysfunction (MDRD <60 mL/min), liver enzyme abnormalities (ALAT >twice upper limit), fasting total cholesterol >6 mmol/L, 2nd/3rd degree AV block on electrocardiography. During the study a serum potassium of >5.2 mmol/L is an exclusion criterium.
    serum kalium >4.8 mmol/L, roken, hypertensie (SBP >140 of DBP >90 mmHg), hypotensie (SBP <100 of DBP <60 mmHg), diabetes mellitus (nuchter glucose >7.0 mmol/L of random >11.0 mmol/L), voorgeschiedenis met cardiovasculaire aandoeningen, angina pectoris, COPD of astma (in voorgeschiedenis), alcohol en/of drugsmisbruik, gebruik van medicatie, nierfunctiestoornis (MDRD <60 mL/min), leverenzymstoornis (ALAT meer dan 2x verhoogd), nuchter cholesterol >6 mmol/L, 2e of 3e graads AV block op ECG. Tijdens de studie worden personen met een serum kalium >5.2 mmol/L uit de studie geëxcludeerd.
    E.5 End points
    E.5.1Primary end point(s)
    forearm blood flow (measured with venous plethysmography). The forearm blood flow respons will be measured during usage of eplerenone and during usage of placebo to:
    1) administration of incremental dosages of dipyridamole into the brachial artery (as a surrogate for adenosine formation)
    2) 2 and 5 minutes of arterial occlusion (post occlusive reactive hyperemia), because this is known to stimulate adenosine formation
    3) co-administration of dipyridamole and caffeine. Dipyridamole increases adenosine formation and this effect is blocked by caffeine.
    4) two different concentrations of adenosine and sodium-nitroprusside. These substances serve as negative control and exclude non-specific effects of eplerenone on vascular reactivity or adenosine sensitivity.
    De bloeddoorstroming in de onderarm wordt met behulp van veneuze plethysmografie gemeten. Experimenten worden tijdens het gebruik van eplerenon en tijdens het gebruik van placebo gedaan en verschil in bloeddoorstroming wordt gemeten in respons op:
    1) verschillende doseringen dipyridamol. Dipyridamol remt de ENT en verhoogt hiermee het extracellulaire gevormde adenosine.
    2) 2 verschillende perioden van arteriële occlusie (2 en 5 min). Het is bekend dat hiermee de adenosinevorming wordt gestimuleerd.
    3) co-administratie van caffeïne. De verhoging van extracellulair adenosine t.g.v. dipyridamol wordt door caffeïne geblokkeerd.
    4) 2 verschillende concentraties van adenosine en sodium-nitroprusside om non-specifieke effecten van eplerenon op de vasculaire reactiviteit en adenosine gevoeligheid uit te sluiten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days after start of eplerenone or placebo, the experiments will be performed. Because not all experiments can be done on the same day, forearm blood flow response to adenosine and sodium-nitroprusside will be performed 8 days after start of eplerenone.
    7 dagen nadat gestart is met eplerenon of de placebo wordt de veneuze plethysmografie uitgevoerd en wordt gekeken naar het effect op de bloeddoorstroming van deze middelen. Omdat niet alle experimenten of 1 dag kunnen worden voltooid, wordt een dag later de bloeddoorstroming met co-administratie van adenosine en natrium-nitroprusside gemeten.
    E.5.2Secondary end point(s)
    not applicable (see E.5.1.1)
    niet van toepassing (zie ook E.5.1.1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    niet van toepassing
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 Yes
    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
    LVLS
    laatste bezoek van de laatste proefpersoon
    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 months4
    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: 14
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state14
    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)
    exit conversation
    exit gesprek/ afsluitend gesprek
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-23
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