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    Summary
    EudraCT Number:2010-024431-17
    Sponsor's Protocol Code Number:INSERT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-28
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-024431-17
    A.3Full title of the trial
    A PILOT STUDY TO EVALUATE THE INCIDENCE OF HYPONATREMIA IN A MEDICAL-SURGICAL HOSPITAL AND TO EXPLORE THE EFFICACY AND SAFETY OF TOLVAPTAN IN THE CLINICAL PRACTICE
    STUDIO PILOTA PER VALUTARE L'INCIDENZA DI IPONATREMIA NEI PAZIENTI OSPEDALIZZATI E PER ESPLORARE L'EFFICACIA E LA SICUREZZA DELL'IMPIEGO DI TOLVAPTAN NELLA PRATICA CLINICA
    A.3.2Name or abbreviated title of the trial where available
    Tolvaptan for in-hospital hyponatremia
    Tolavaptan nei pazienti ospedalizzati
    A.4.1Sponsor's protocol code numberINSERT
    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 SponsorIST. DI RICERCHE FARMACOLOG. M. NEGRI
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 SAMSCA
    D.2.1.1.2Name of the Marketing Authorisation holderOTSUKA PHARMACEUTIC.ITALY Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number15
    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
    Hyponatremia
    Iponatremia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021036
    E.1.2Term Hyponatraemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 compare between the two treatment arms: - the proportion of subjects achieving normonatremia (Serum sodium>135 mEq/L); - the absolute changes vs baseline in serum sodium levels considered as a continuous variable.
    Paragonare nei due gruppi di trattamento: - La percentuale di soggetti che raggiungono la normonatremia (Sodio nel sangue &gt;135 mEq/L) - Le variazioni assolute rispetto al basale dei livelli di sodio nel sangue considerate come una variabile continua
    E.2.2Secondary objectives of the trial
    To compare between the two treatment arms: - The proportion of subjects achieving normonatremia and absolute changes in serum sodium levels vs baseline at discharge and at predefined time-points including 8 hours, 1, 2, 3, and 10 days and 1, 2, 4 and 6 months after randomization; - Time to normalization in serum sodium levels (Serum sodium >135 mEq/L) confirmed in at least 2 consecutive evaluations; - Duration of fluid restriction, use of hypertonic saline for rescue therapy, time to reintroduction of diuretic, length of hospital stay, incidence of re-hospitalization; - Cost-effectiveness; - Quality of life.
    Paragonare nei due gruppi di trattamento: - La percentuale dei soggetti che raggiungono la normonatremia e le variazioni assolute nei livelli di sodio nel sangue rispetto al basale al momento della dimissione, alle 8 ore, a 1, 2, 3 e 10 giorni e a 1, 2, 4 e 6 mesi dopo la randomizzazione - Il tempo in cui si normalizzano i livelli di sodio nel sangue (sodio nel sangue &gt;135 mEq/L) confermati in almeno due valutazioni consecutive - Durata della restrizione idrica, uso di soluzione salina ipertonica per rescue therapy, tempo di reintroduzione del diuretico, durata dell’ospedalizzazione, incidenza di riospedalizzazione - Rapporto costo-efficacia - Qualita' della vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Non artifactual hyponatremia in euvolemic or hypervolemic states, defined as serum sodium <135 mEq/L confirmed in at least 2 consecutive evaluations; - 18 years of age or older; - Able to give written Informed Consent.
    - Iponatremia non dovuta ad artefatti in condizioni di eu- o ipervolemia, definita come rilevazione di valori di sodio nel sangue &lt;135 mEq/L in almeno due misurazioni consecutive; - Eta' uguale o maggiore di 18 anni; - Capacita' di fornire il consenso informato scritto.
    E.4Principal exclusion criteria
    - Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods; - Hyponatremia in hypovolemic states; - Acute and transient hyponatremia associated with head trauma or post-operative state; - Hyponatremia due to uncontrolled hypothyroidism or uncontrolled adrenal insufficiency; - Cardiac surgery within 30 days prior to the potential study enrollment, excluding percutaneous coronary interventions; - History of a myocardial infarction within 30 days prior to the potential study enrollment; - History of sustained ventricular tachycardia or ventricular fibrillation within the last 30 days, unless in the presence of an automatic implantable cardioverter defibrillator; - Severe angina including angina at rest or at slight exertion and/or unstable angina; - History of a cerebrovascular accident within the last 30 days; - Subjects with psychogenic polydipsia may not be included, however subjects with other psychiatric illness may be included; - Systolic arterial blood pressure <90 mmHg; - History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril); - History of drug or medication abuse within the past year, or current alcohol abuse; - Uncontrolled diabetes mellitus defined as fasting glucose >300mg/dL; - Urinary tract obstruction except BPH if non-obstructive; - Terminally ill or moribund condition with little chance of short-term survival; - Serum creatinine >3.5 mg/dL; - Serum sodium <120 mEq/L with associated neurologic impairment, i.e. symptoms such as apathy, confusion, seizures; - Patients with progressive or episodic neurologic disease such as multiple sclerosis or history of multiple strokes; - Child-Pugh score greater than 10 (unless approved); - Patients receiving intravenous fluids at a rate greater than KVO (Keep Vein Open); - Hyponatremia due to lab artifacts; - Patients receiving AVP or its analogs for treatment of any condition; - Patients receiving within 7 days of randomization, other medications for treatment of hyponatremia specifically: demeclocycline, lithium carbonate or urea; - Patients likely requiring IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study; - Severe pulmonary artery hypertension; - Hyponatremia should not be the result of any medication that can safely be withdrawn.
    - Donne in stato di allattamento o potenzialmente fertili che non utilizzino metodi contraccettivi scientificamente approvati; - Iponatremia in condizione di ipovolemia; - Iponatremia acuta e transitoria associata a trauma alla testa o ad un intervento chirurgico; - Iponatremia dovuta a ipotiroidismo incontrollato o a insufficienza delle surrenali; - Interventi chirurgici al cuore nei 30 giorni precedenti l’arruolamento nello studio, con l’eccezione di interventi percutanei alle coronarie; - Infarto del miocardio nei 30 giorni precedenti l’arruolamento nello studio; - Tachicardia ventricolare sostenuta o fibrillazione ventricolare nei 30 giorni precedenti l’arruolamento, tranne che nei pazienti che abbiano impiantato un defribillatore per cardioversione; - Angina severa compresa l’angina a riposo e/o angina instabile; - Ictus nei 30 giorni precedenti l’arruolamento; - I soggetti con polidipsia psicogena non possono essere inclusi, a differenza dei soggetti con altre patologie psichiatriche; - Pressione sistolica &lt;90 mmHg; - Ipersensibilita' o reazione idiosincrasica alle benzazepine e ai loro derivati ( come il benazepril); - Storia d’abuso di farmaci negli anni precedenti o abuso d’alcol; - Diabete mellito incontrollato definito come glucosio a digiuno &gt;300mg/dL; - Ostruzione del tratto urinario ad eccezione di BPH se non ostruttivo; - Malati terminali o moribondi; - Creatinina sierica &gt;3.5 mg/dL - Valori di sodio nel sangue &lt;120 mEq/L associati a problemi neurologici quali apatia, confusione, attacchi epilettici; - Pazienti con malattie neurologiche progressive o episodiche come sclerosi multipla o ictus ripetuti; - Score di Child-Pugh maggiore di 10; - Pazienti che ricevono liquidi per via intravenosa ad una velocita' maggiore di KVO; - Iponatremia dovuta ad artefatti di laboratorio; - Pazienti che ricevano AVP o suoi analoghi; - Pazienti la cui iponatremia, nei 7 giorni precedenti la randomizzazione siano stati trattati con altri farmaci, in particolare demeclociclina, carbonato di litio o urea; - Pazienti che necessitino nel corso dello studio di infusione IV di salina per la correzione sintomatica o asintomatica di una severa iponatremia; - Severa ipertensione dell’arteria polmonare; - Iponatremia non deve dipendere da nessun farmaco che possa essere sospeso senza pregiudicare la sicurezza del paziente.
    E.5 End points
    E.5.1Primary end point(s)
    Normonatremia (Serum sodium>135 mEq/L).
    Normonatremia (Sodio sierico >135 mEq/L).
    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 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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia convenzionale
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 state100
    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 Decision2011-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-07-26
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