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    Summary
    EudraCT Number:2017-004701-40
    Sponsor's Protocol Code Number:TOOL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004701-40
    A.3Full title of the trial
    A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF
    TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY
    IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION
    A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF
    TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY
    IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION
    PROPOSTA DI STUDIO PER VALUTARE L’EFFETTO A BREVE TERMINE DELLA SOMMINISTRAZIONE DI TOLVAPTAN E PLACEBO RISPETTO ALLA COMBINAZIONE DI TOLVAPTAN E OCTREOTIDE LAR IN PAZIENTI AFFETTI DA MALATTIA POLICISTICA DEL RENE CON FUNZIONE RENALE NORMALE O IPERFILTRANTI
    A.3.2Name or abbreviated title of the trial where available
    Tolvaptan-Octreotide combination in ADPKD
    Terapia combinata con Tolvaptan e Octreotide nella malattia del rene policistico autosomico dominant
    A.4.1Sponsor's protocol code numberTOOL
    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 SponsorIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO 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 supportOtsuka
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportIRCCS ISTITUTO MARIO NEGRI
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS ISTITUTO MARIO NEGRI
    B.5.2Functional name of contact pointLAB. ATTIVITà REGOLATORIE RELATIVE
    B.5.3 Address:
    B.5.3.1Street AddressVIA G. B. CAMOZZI 3
    B.5.3.2Town/ cityRANICA
    B.5.3.3Post code24020
    B.5.3.4CountryItaly
    B.5.4Telephone number03545351
    B.5.5Fax number0354535371
    B.5.6E-mailpaola.boccardo@marionegri.it
    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 JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG)
    D.2.1.1.2Name of the Marketing Authorisation holderOTSUKA PHARMACEUTICAL EUROPE LTD
    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.3.1Product nameJinarc
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOLVAPTAN
    D.3.9.2Current sponsor codeTolvaptan
    D.3.9.3Other descriptive nameTOLVAPTAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number60 to 120
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG)
    D.2.1.1.2Name of the Marketing Authorisation holderOTSUKA PHARMACEUTICAL EUROPE LTD
    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.3.1Product nameJinarc
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOLVAPTAN
    D.3.9.2Current sponsor codeTolvaptan
    D.3.9.3Other descriptive nameTOLVAPTAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number60 to 120
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG)
    D.2.1.1.2Name of the Marketing Authorisation holderOTSUKA PHARMACEUTICAL EUROPE LTD
    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.3.1Product nameJinarc
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOLVAPTAN
    D.3.9.2Current sponsor codetolvaptan
    D.3.9.3Other descriptive nameTOLVAPTAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number60 to 120
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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 SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA S.P.A.
    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.3.1Product namesandostatina LAR
    D.3.2Product code sandostatina
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autosomal Dominant Policiytic Kidney Disease
    Malattia del rene policistico autosomico dominante
    E.1.1.1Medical condition in easily understood language
    Autosomal Dominant Policystic Kidney Disease
    Malattia del rene policistico autosomico dominante
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of 4-week Tolvaptan and Octreotide LAR combination therapy as compared to Tolvaptan and Placebo combination therapy on GFR, as assessed by the Iohexol Plasma Clearance Technique, in 20 ADPKD patients with normal kidney function (GFR: >80 and <120 ml/min/1.73m2) or hyperfiltration (GFR >120 ml/min/1.73m2).
    Valutare l’effetto sul GFR (misurato con la tecnica della clearance dello ioexolo) della somministrazione per quattro settimane di Tolvaptan e Octreotide LAR rispetto a Tolvaptan e placebo, in 20 pazienti affetti da ADPKD con funzione renale normale (GFR: >80 e <120 ml/min/1.73m2) o iperfiltranti (GFR >120 ml/min/1.73m2).
    E.2.2Secondary objectives of the trial
    To evaluate the effect of 4-week Tolvaptan and Octreotide LAR combination therapy as compared to Tolvaptan and Placebo Combination therapy on TKV percentage changes as assessed by MRI, in 20 ADPKD patients with normal kidney function or hyperfiltration.
    Valutare l’effetto sulle variazioni percentuali del TKV (misurato con la risonanza magnetica) della somministrazione per quattro settimane di Tolvaptan e Octreotide LAR rispetto a Tolvaptan e placebo, in 20 pazienti affetti da ADPKD con funzione renale normale o iperfiltranti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult (>18-yr-old) men and women, with a clinical and ultrasonographic diagnosis of ADPKD;
    2. Serum creatinine < 1.0 mg/dl (for man) and < 1.2 mg/dl (for woman) and changes in serum creatinine (and creatinine clearance when available) <30% over the last six months;
    3. Creatinine clearance > 80 ml/min/1.73m2 measured one to two weeks apart during the pre-screening period;
    4. GFR ≥ 80 ml/min/1.73m2 (by iohexol plasma clearance technique) at screening and baseline evaluations;
    5. TKV ranging between 1000 and 2000 ml at screening (by ultrasound imaging) and at baseline (by MRI) evaluations;
    6. Female participants must be of non-childbearing potential or must agree to abstinence or use a highly effective form of contraception;
    7. Written informed consent.
    1. Donne e uomini di età >18 anni, con diagnosi clinica ed ecografica di ADPKD;
    2. Creatinina sierica < 1.0 mg/dl (per gli uomini) e < 1.2 mg/dl (per le donne) e variazioni nei valori di creatinina sierica (e clearance della creatinina quando disponibile) <30% nei 6 mesi precedenti l’inizio dello studio;
    3. Clearance della creatinina > 80 ml/min/1.73m2 misurata con un intervallo da una a due settimane durante il periodo pre-screening;
    4. GFR ≥ 80 ml/min/1.73m2 (misurato con la clearance plasmatica dello ioexolo) allo screening e al basale;
    5. TKV compreso tra 1000 e 2000 ml allo screening (determinato con l’ecografia) e al basale (determinato con la risonanza magnetica);
    6. Le donne che parteciperanno allo studio devono essere non fertili o devono accettare di praticare l’astinenza o utilizzare un metodo contraccettivo efficace per tutta la durata dello studio;
    7. Consenso informato scritto.
    E.4Principal exclusion criteria
    1. Patients with concomitant systemic, renal parenchymal or urinary tract disease;
    2. Diabetes;
    3. Overt proteinuria (urinary protein excretion rate >1 g/24 hours);
    4. Abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease, urinary tract lithiasis, infection or obstruction, biliary tract lithiasis or obstruction;
    5. Hemorrhagic or complicated cysts which might acutely affect kidney function and volumes;
    6. QT-related ECG abnormalities;
    7. Cancer and major systemic diseases that could prevent completion of the planned follow-up or interfere with data collection or interpretation;
    8. Hypersensitivity to the IMP active substance or to any of the excipients or to benzazepine or benzazepine derivatives;
    9. Concomitant treatment with drugs that may affect glomerular hemodynamics during the three months before the beginning of the study (including ACE inhibitors, angiotensin receptor blockers, aldosterone antagonists and non-steroideal anti-inflammatory medications);
    10. Elevated liver enzymes and/or signs or symptoms of liver injury prior to initiation of treatment that meet the requirements for permanent discontinuation of tolvaptan
    11. Patients with anuria, volume depletion and hypernatraemia
    12. Patients who cannot perceive or respond to thirst
    13. Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or any other contraindication to MRI evaluation;
    14. Psychiatric disorders and any condition that could prevent full comprehension of the purposes and risks of the study;
    15. Pregnant or lactating;
    16. Participation in another interventional clinical trial within the 4 weeks prior to screening.
    1. Pazienti con malattie concomitanti sistemiche, parenchimali renali o a carico del tratto urinario;
    2. Diabete;
    3. Proteinuria conclamata (escrezione urinaria di proteine >1 g/24 ore);
    4. Anomalie nell’analisi delle urine tali da far ipotizzare la presenza di malattie glomerulari concomitanti, litiasi, infezioni o ostruzione a carico delle vie urinarie, litiasi o ostruzione del tratto biliare;
    5. Cisti emorragiche o complicate che potrebbero compromettere la funzione e il volume del rene;
    6. Anomalie dell’ECG relative all’intervallo QT;
    7. Cancro, malattie sistemiche importanti che potrebbero impedire il completamento del follow-up previsto dal protocollo o interferire con la raccolta o l’interpretazione dei dati;
    8. Ipersensibilità al principio attivo del prodotto sperimentale o ad uno qualsiasi degli eccipienti o a benzazepine o loro derivati;

    9. Trattamenti concomitanti con farmaci che potrebbero alterare l’emodinamica renale nei tre mesi precedenti l’inizio dello studio (inclusi ACE inibitori, antagonisti del recettore dell’angiotensina, antagonisti dell’aldosterone e farmaci antinfiammatori non steroidei);
    10. Enzimi epatici elevati e/o segni o sintomi di danno epatico prima dell’inizio del trattamento, che soddisfino i requisiti per l’interruzione permanente di tolvaptan;
    11. Pazienti con anuria, ipovolemia e ipernatremia;
    12. Pazienti non in grado di avvertire o di rispondere allo stimolo della sete;
    13. Protesi ferro-magnetiche, clip per aneurisma, claustrophobia grave o qualsiasi altra controindicazione alla risonanza magnetica;
    14. Disordini psichiatrici e qualsiasi condizione che possa impedire la piena comprensione degli scopi e dei rischi dello studio;
    15. Donne in gravidanza o allattamento;
    16. Partecipazione ad un altro studio clinico interventistico nelle 4 settimane che precedono il periodo di screening.
    E.5 End points
    E.5.1Primary end point(s)
    Effect of 4-week Tolvaptan and Octreotide LAR combination therapy as compared to Tolvaptan and Placebo combination therapy on GFR, assessed
    by the Iohexol Plasma Clearance Technique.
    Valutare l’effetto sul GFR (misurato con la tecnica della clearance dello ioexolo) della somministrazione per quattro settimane di Tolvaptan e Octreotide LAR rispetto a Tolvaptan e placebo, in 20 pazienti affetti da ADPKD con funzione renale normale (GFR: >80 e <120 ml/min/1.73m2) o iperfiltranti (GFR >120 ml/min/1.73m2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks before the randomization, at baseline, 1,4,8,9,12 and 16 weeks after randomization
    4 settimane prima della randomizzazione, al basale, 1, 4, 8, 9, 12 e 16 settimane dopo la randomizzazione.
    E.5.2Secondary end point(s)
    Effect of 4-week Tolvaptan and Octreotide LAR combination therapy as compared to Tolvaptan and Placebo Combination therapy on TKV percentage changes assessed by MRI.
    Valutare l’effetto sulle variazioni percentuali del TKV (misurato con la risonanza magnetica) della somministrazione per quattro settimane di Tolvaptan e Octreotide LAR rispetto a Tolvaptan e placebo, in 20 pazienti affetti da ADPKD con funzione renale normale o iperfiltranti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline (randomization), 4, 8, 12 and 16 weeks after the randomization.
    Al basale (randomizzazione), 4, 8,12 e 16 settimane dopo la randomizzazione.
    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 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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 natural conclusion of the clinical trial coincides with the closure of the study database.
    Lo studio si definirà concluso al momento della chiusura del database.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    The patients will be followed with the best therapy available.
    I pazienti proseguiranno con il miglior trattamento possibile.
    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 Decision2018-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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