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    Summary
    EudraCT Number:2011-005683-21
    Sponsor's Protocol Code Number:ENM-EA-030
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-12
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-005683-21
    A.3Full title of the trial
    Effects of eplerenone on parathyroid hormone levels in patients with primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial
    Studie zur Untersuchung der Effekte von Eplerenon auf die Parathormonkonzentration bei PatientInnen mit einem primären Hyperparathyreoidismus: Eine randomisierte, doppel-blinde, Plazebo kontrollierte Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of the mineralocorticoid-receptor blocker eplerenone on parathyroid hormone levels in patients with parathyroid hormone excess
    Effekte einer Mineralokortikoidrezeptorblokade mit Eplerenon auf die Parathormonkonzentration in PatientInnen mit einem Parathormonüberschuss
    A.3.2Name or abbreviated title of the trial where available
    EPATH: Eplerenone in hyperPAraTHyroidism Study
    EPATH: Eplerenon bei primären Hyperparathyreoidismus
    A.4.1Sponsor's protocol code numberENM-EA-030
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN33941607
    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 SponsorMedizinische Universität Graz
    B.1.3.4CountryAustria
    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 supportPfizer
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Graz
    B.5.2Functional name of contact pointKlin. Abt. für Kardiologie
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number004331638512544
    B.5.5Fax number004331638513733
    B.5.6E-mailandreas.tomaschitz@gmx.at
    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 Inspra 25 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Corporation Austria
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameInspra 25 mg tablets
    D.3.2Product code 0025-1710-01
    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 INNInspra
    D.3.9.1CAS number 107724-20-9
    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 number25
    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.IMP: 2
    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 Inspra 50mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Corporation Austria
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameInspra 50mg tablets
    D.3.2Product code 0025-1710-01
    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 INNInspra
    D.3.9.1CAS number 107724-20-9
    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 number50
    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 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
    Primary hyperparathyroidism
    Primärer Hyperparathyreoidismus
    E.1.1.1Medical condition in easily understood language
    Primary hyperparathyroidism is characterized by an inadequately
    elevated parathyroid hormone production in regard of the concurrent serum (ionized) calcium concentration.
    Der primäre Hyperparathyreoidismus ist durch eine im Vergleich zur
    Serumkalziumkonzentration inadäquat gesteigerte
    Parathormonproduktion gekennzeichnet.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 of the EPATH Study is to evaluate in patients with primary hyperparathyroidism (PHPT) whether eplerenone treatment 50 mg once daily [treatment will be initiated at 25 mg once daily and titrated 50 mg once daily, after 4 weeks as tolerated by the patient]. (1) reduces PTH levels (PTH 1-84) - in the format of a single-center, randomized, double-blind, placebo-controlled trial.
    Ziel der EPATH Studie ist es daher die Effekte einer Blockade der
    Aldosteronwirkung mit Eplerenon (MR-Blockade) auf die PTH-Sekretion bei PatientInnen mit einem primären Hyperparathyreoidismus zu evaluieren.
    E.2.2Secondary objectives of the trial
    The objective of the EPATH Study is to evaluate in patients with primary hyperparathyroidism (PHPT) whether eplerenone treatment 50 mg once daily [treatment will be
    initiated at 25 mg once daily and titrated 50 mg once daily, after 4 weeks as tolerated by the patient] (1) affects bone metabolism and (2) exerts beneficial effect on cardiovascular and renal parameters (24-hours systolic and diastolic blood pressure, echocardiographic parameters, NT-pro-brain natriuretic peptide (NT-pBNP), osteoprotegerin and 24-hour urinary albumin/protein excretion) - in the format of a single-center, randomized, double-blind, placebo-controlled trial.
    Ziel der EPATH Studie ist es daher die Effekte einer Blockade der
    Aldosteronwirkung mit Eplerenon (MR-Blockade) auf die (1) den Knochenstoffwechsel und (2) auf verschiedene, kardiovaskuläre Surrogatparameter bei PatientInnen mit einem primären Hyperparathyreoidismus zu evaluieren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent
    • Patients with primary hyperparathyroidism (PHPT) (diagnostic workup of patients with PHPT will be performed according to the "2008 Guidelines" (stated in chapters 2.1.4 and 2.1.5) before enrollment into the EPATH Study and after thorough exclusion of other causes of elevated PTH and hypercalcemia):
    - asymptomatic PHPT who do not meet guidelines for surgical treatment (according to the "2008 Guidelines" published by Bilezikian et al. J Clin Endocrinol Metab 2009; 94(2):335-339.)
    - symptomatic PHPT in whom surgery is recommended, but not
    performed because of patient and/or physician preference or perceived
    medical contraindications
    • Age ≥ 18 years
    Informed Consent, Alter von mindestens 18 Jahren, asymptomatischer primärer Hyperparathyreoidismus ohne Indikation zur chirurgischen Therapie entsprechend
    der Richtlinien der Endocrine Society "2008 Arbeitsgruppe - PHPT" [J Clin Endocrinol Metab 2009; 94(2):335-339.], symptomatischer PHPT mit Indikation zur chirurgischen Therapie, wobei aufgrund der fehlenden Operationstauglichkeit oder Operationswunsches keine chirurgische Therapie durchgeführt werden kann.
    E.4Principal exclusion criteria
    • 25(OH)D levels < 20 ng/dl (50 nmol/liter)
    • Estimated glomerular filtration rate (GFR; according to the MDRD formula) ≤ 50 ml/min
    • Serum potassium > 5.0 mEq/L (mmol/L) at baseline or > 5.5 mEq/L (mmol/L) during active study period
    • Pregnancy or lactating women
    • Drug intake as part of another clinical study 4 weeks before enrolment into the EPATH study and/or during the active study periode
    • Any disease with an estimated life expectancy below 1 year
    • Chemotherapy or radiation therapy during the study
    • Intolerance to eplerenone or any ingredient occurring in eplerenone
    • Severe acute or chronic liver diseases (Child-Pugh Class C)
    • Concurrent intake of potassium sparing drugs, e.g. diuretics (amiloride and triamterene) or CPY3A4-inhibitors and ongoing potassium supplementation
    • Vitamin D Spiegel (25(OH)D) <20 ng/dL (50 nmol/L),
    • berechnete (e)GFR < 50 ml/min/1,73 m²
    • Serumkalium > 5,0 mEq/L (mmol/L) zum Zeitpunkt des Studieneinschlusses sowie ein Serumkalium > 5,5 mEq/L /mmol/L) während der aktiven Studienperiode
    • Schwangerschaft und stillende Frauen
    • Medikamenteneinnahme im Rahmen einer anderen klinischen Studie
    • bekannte Unverträglichkeit von Eplerenon oder Inhaltsstoffen von Eplerenon
    • Schwere akute oder chronische Leberfunktionseinschränkungen (Child-Pugh Class C)
    • schwere Erkrankungen mit voraussichtlicher Lebenserwartung von unter 1 Jahr
    • laufende Chemotherapie oder Strahlentherapie
    • Gleichzeitige Einnahme von Kaliumsparenden Diuretika (z.B.:Amilorid oder Triamteren) oder Einnahme von CPY3A4-inhibitoren oder laufende Kaliumsubsituttion
    E.5 End points
    E.5.1Primary end point(s)
     After 8 weeks:
    • mean change of iPTH(1-84) levels from baseline to the third visit
    Das primäre Studienziel ist es in einer randomisierten Placebo
    kontrollierten Studie zu evaluieren, ob die Gabe von Eplerenon 50mg (25mg für 4 Wochen, danach Dosistitration bei fehlenden
    Nebenwirkungen/Konraindikationen) tgl. über 8 Wochen zu
    einer signifikanten Reduktion der PTH-Konzentration (nach 8 Wochen) bei PatientInnen mit einem PHPT (bei fehlender Indikation zu einer chirurgischen Therapie) hat.
    E.5.1.1Timepoint(s) of evaluation of this end point
     After 8 weeks:
    • mean change of iPTH(1-84) levels from baseline to the third visit
    Nach 8 Wochen
    E.5.2Secondary end point(s)
     After 8 weeks:
    • mean change of 24-hour systolic and diastolic ambulatory BP levels from baseline to the third visit
    • mean change of NT-pro-BNP and osteoprotegerin from baseline to the third visit
    • Mean change of biomarkers of bone metabolism: osteocalcin, β-
    CrossLaps, bone alkaline phosphatase, tartrate-resistant acid
    phosphatase from baseline to the fifth visit
    • 24 hours urinary protein and albumin excretion from baseline to the fifth visit
    • mean change of functional and structural echocardiographic LV parameters
    Sekundäre Studienziele sind die Evaluierung von Einflüssen einer
    Eplerenongabe auf:
    Systolischen und diastolischen Blutdruckmittelwert, sowie mittleren arteriellen Blutdruck einer ambulanten 24 Stunden Blutdruckmessung, NT-pro-BNP und Osteoprotegerin (nach 8 Wochen), 24-Stunden Harn: Gesamteiweiss- und Albuminausscheidung (nach 8
    Wochen), Knocherumbauparameter: Osteocalcin, β-CrossLaps, Knochen Alkalische Phosphatase, Tartrat-resistente saure Phosphatase, echocardiographische Parameter der LV Struktur und Funktion
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 Wochen
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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
    The trial ends after the last study visit afer 8 weeks
    Die aktive Phase der Studie endet nach 8 Wochen
    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 months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state110
    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)
    Patients with primary hyperparathyroidisms will be regurarily managed by the department of internal medicine, division of endocrinology and metabolism, medical university of Graz after participation (or exlcusion) of the trial.
    Alle PatientInnen mit einem primären Hyperparathyreoidismus, die an der EPATH Studie teilnehmen, werden nach Beendigung der aktiven Studienphase (oder nach Austritt aus der Studie bei Wunsch oder nach Ausschluss aus der Studie bei Vorliegen entspr. Ausschlusskriterien) im Rahmen der klinischen Routine über die Klinische Abt. Endokrionlogie und Stoffwechsel, Univ. Klinik für Innere Medizin, der Medizinischen Universität Graz betreut.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medical University of Graz
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
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