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    Summary
    EudraCT Number:2016-005141-23
    Sponsor's Protocol Code Number:021FSGS16010
    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:2021-01-15
    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 number2016-005141-23
    A.3Full title of the trial
    A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)
    Studio randomizzato, multicentrico, in doppio cieco, a gruppi paralleli, con controllo attivo degli effetti di sparsentan, un bloccante duplice del recettore dell’endotelina e del recettore dell’angiotensina, sugli esiti renali in pazienti con glomerulosclerosi focale segmentaria (FSGS) primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)
    Effetti e Sicurezza di Sparsentan come trattamento per glomerulosclerosi focale segmentaria (FSGS) primaria
    A.3.2Name or abbreviated title of the trial where available
    Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (
    Efficacia e sicurezza di Sparsentan come trattamento per la glomerulosclerosi focale segmentaria (FS
    A.4.1Sponsor's protocol code number021FSGS16010
    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 SponsorRETROPHIN, INC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRetrophin Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRetrophin, Inc.
    B.5.2Functional name of contact pointRetrophin Call Center
    B.5.3 Address:
    B.5.3.1Street Address3721 Valley Centre Drive, Suite 200
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number187765955
    B.5.5Fax number187765955
    B.5.6E-mailcallcenter@retrophin.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1574
    D.3 Description of the IMP
    D.3.1Product nameSparsentan
    D.3.2Product code [R-021]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 254740-64-2
    D.3.9.2Current sponsor codeRE-021
    D.3.9.4EV Substance CodeSUB168607
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 Irbesartan
    D.2.1.1.2Name of the Marketing Authorisation holderCatalent CTS, LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIRBESARTAN
    D.3.2Product code [SUB08293MIG]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 138402-11-6
    D.3.9.2Current sponsor code43547-0374-03
    D.3.9.4EV Substance CodeSUB08293MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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 Irbesartan tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMilpharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameover-encapsulated Irbesartan
    D.3.2Product code [over-encapsulated Irbesartan]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNIrbesartan
    D.3.9.1CAS number 138402-11-6
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameIrbesartan
    D.3.9.4EV Substance CodeSUB08293MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Focal segmental glomerulosclerosis (FSGS)
    Glomerulosclerosi focale segmentaria (FSGS) primaria
    E.1.1.1Medical condition in easily understood language
    Scarring of the tissue in the filtering unit of the kidney (glomerulus).
    Cicatrizzazione del tessuto nell'unità filtrante del rene (glomerulo).
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The efficacy objective of the study is to determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary FSGS.

    The safety objective of the study is to assess the safety and tolerability of sparsentan by double-blind monitoring of safety endpoints.
    L’obiettivo di efficacia dello studio è determinare il potenziale nefroprotettivo a lungo termine del trattamento con sparsentan rispetto a un bloccante del recettore dell’angiotensina in pazienti con glomerulosclerosi focale segmentaria (FSGS) primaria. L’obiettivo di sicurezza dello studio è valutare la sicurezza e la tollerabilità di sparsentan mediante monitoraggio in doppio cieco degli endpoint di sicurezza.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent, and where required, the patient is willing to provide assent, prior to any screening procedures.
    2. The patient has biopsy-proven primary FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS. The biopsy may have been performed at any time in the past, but will preferably include electron microscopy (EM) and immunofluorescence (IF) characteristics consistent with primary FSGS. The patient may be enrolled based on light microscopy diagnosis of FSGS in the absence of EM and/or IF analysis, provided the history (nephrotic syndrome with hypoalbuminemia, treatment with immunosuppression) and the course of the disease are indicative of primary FSGS, and potential secondary causes captured by the exclusion criteria have been carefully ruled out.
    3. Sites within the US: The patient is male or female aged 8 to 75 years, inclusive.
    Sites outside the US: The patient is male or female aged 18 to 75 years, inclusive.
    4. The patient has a UP/C =1.5 g/g at screening.
    5. The patient has an eGFR =30 mL/min/1.73 m2 at screening.
    6. The patient has a mean seated blood pressure =100/60 mmHg (on a maximum of 2 antihypertensive treatments at screening, including RAAS inhibitors) and =160/100 mmHg (patients >18 years of age) or =90/60 mmHg and = the 95th percentile for age, sex, and height (patients =18 years of age).
    7. Sexually active women of childbearing potential (WOCBP) must agree to the simultaneous use of 2 medically accepted methods of contraception from Day 1/Randomization until 90 days after the last dose of study medication. At least one method of contraception must be highly reliable (ie, can achieve a failure rate of <1% per year), such as stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in place for at least 3 months. The other method of contraception must be a barrier method, such as a diaphragm with spermicide or male partner’s use of male condom with spermicide. WOCBP are defined as those who are fertile, following menarche and until becoming postmenopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as amenorrhea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level >40 mIU/mL. All WOCBP must have a negative pregnancy test (urine, with positive results confirmed by serum) at Visits 1 and 3 (Screening and Day 1/Randomization).
    NOTE: Prior to menarche, pregnancy testing and contraceptive use is not required. However, the patient and their parent/guardian must be advised that, immediately upon menarche, the patient will be required to begin pregnancy testing and, if deemed necessary by the Investigator, initiate contraceptive use. This requirement cannot be avoided.
    8. Males must be surgically sterile (more than 3 months post-vasectomy) or must agree to the use of medically accepted methods of contraception that are considered highly reliable from Day 1/Randomization until 90 days after the last dose of study medication.
    1. Il paziente o genitore/tutore legale (ove pertinente) è disposto a e in grado di fornire il consenso informato firmato e, ove richiesto, il paziente è disposto a fornire l’assenso, prima di qualsiasi procedura di screening.
    2. Il paziente presenta FSGS primaria confermata da biopsia o dispone della documentazione di una mutazione genetica in una proteina podocitica associata alla FSGS. La biopsia può essere stata eseguita in qualsiasi momento in passato, ma dovrà includere preferibilmente caratteristiche di microscopia elettronica (ME) e immunofluorescenza (IF) coerenti con FSGS primaria. Il paziente può essere arruolato in base a una diagnosi di FSGS con microscopia ottica in assenza di un’analisi mediante ME e/o IF, a condizione che l’anamnesi (sindrome nefrotica con ipoalbuminemia, trattamento con immunosoppressione) e il decorso della malattia indichino la presenza di FSGS primaria e che siano state accuratamente escluse potenziali cause secondarie contemplate dai criteri di esclusione.
    3. Centri negli USA: il paziente è di sesso maschile o femminile di età da 8 a 75 anni, compresi.
    Centri al di fuori degli USA: il paziente è di sesso maschile o femminile di età da 18 a 75 anni, compresi.
    4. Il paziente presenta un rapporto Up/C =1,5 g/g allo screening.
    5. Il paziente presenta una eGFR =30 ml/min/1,73 m2 allo screening.
    6. Il paziente presenta una pressione sanguigna media da seduto =100/60 mmHg (durante un massimo di 2 trattamenti antipertensivi allo screening, compresi gli inibitori del RAAS) e =160/100 mmHg (pazienti di età >18 anni) o =90/60 mmHg e =95 percentile per età, sesso e altezza (pazienti di età =18 anni).
    7. Le donne in età fertile (WOCBP) sessualmente attive devono acconsentire all’uso simultaneo di 2 metodi contraccettivi accettabili a livello medico dal Giorno 1/dalla randomizzazione fino a 90 giorni dopo l’ultima dose del farmaco dello studio. Almeno un metodo contraccettivo deve essere altamente affidabile (ovvero, in grado di raggiungere un tasso di fallimento <1% annuo), quali ormoni contraccettivi orali, impiantabili, transdermici o iniettabili stabili associati all’inibizione dell’ovulazione, oppure un dispositivo intrauterino (IUD) inserito da almeno 3 mesi. L’altro metodo contraccettivo deve essere un metodo barriera, quali diaframma con spermicida o uso del preservativo maschile con spermicida da parte del compagno. Per WOCBP si intendono donne fertili post-menarca e fino all’inizio del periodo post-menopausale, a meno che non siano permanentemente sterili; i metodi di sterilizzazione permanente includono isterectomia, salpingectomia bilaterale ed ooforectomia bilaterale. Per stato post-menopausale si intende la presenza di amenorrea da oltre 24 mesi consecutivi senza una causa medica alternativa; le donne che assumono una terapia di sostituzione ormonale devono avere un livello documentato di ormone follicolo-stimolante plasmatico >40 mUI/ml. Tutte le WOCBP devono risultare negative al test di gravidanza (sulle urine, con risultati positivi confermati sul siero) alle Visite 1 e 3 (screening e Giorno 1/randomizzazione).
    NOTA: prima del menarca, non sono necessari né il test di gravidanza né l’uso di contraccettivi. Tuttavia, la paziente e il rispettivo genitore/tutore devono essere consapevoli del fatto che, immediatamente dopo il menarca, la paziente dovrà iniziare a sottoporsi a test di gravidanza e, se ritenuto necessario dallo sperimentatore, iniziare l’uso di contraccettivi. Questo requisito non può essere eluso.
    8. Gli uomini devono essere chirurgicamente sterili (>3 mesi post-vasectomia) o devono acconsentire all’uso di metodi contraccettivi accettabili a livello medico e considerati altamente affidabili dal Giorno 1/dalla randomizzazione fino a 90 giorni dopo l’ultima dose del farmaco dello studio.
    E.4Principal exclusion criteria
    1. FSGS secondary to another condition.
    2. Positive findings on serological tests of primary or secondary glomerular injury.
    3. Indications of relapse from complete remission.
    4. History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose
    >180 mg/dL at screening.
    5. Any organ transplantation, with the exception of corneal transplants.
    6. Treatment with any of the prohibited concomitant medications.
    7. Treatment with rituximab, cyclophosphamide, or abatacept within =3
    months prior to screening. If a patient is taking other chronic
    immunosuppressive medications, the dosage must be stable for =1
    month prior to randomization.
    8. Documented history of heart failure and/or previous hospitalization
    for heart failure or unexplained dyspnea, orthopnea, paroxysmal
    nocturnal dyspnea, ascites, and/or peripheral edema.
    9. Clinically significant cerebrovascular disease and/or coronary artery
    disease.
    10. Hemodynamically significant valvular disease.
    11. Jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or transaminase levels >2 times the upper limit of the normal range at screening.
    12. Positive at screening for the human immunodeficiency virus (HIV) or
    markers indicating acute or chronic hepatitis B (HBV) infection or
    hepatitis C virus (HCV) infection.
    13. History of malignancy other than adequately treated basal cell or
    squamous cell skin cancer or cervical carcinoma within the past 2 years.
    14. A screening hematocrit value <27% or hemoglobin value <9 g/dL.
    15. A screening potassium value of >5.5 mEq/L.
    16. Body mass index (BMI) >40.
    17. Female patient is pregnant, breastfeeding, or planning to conceive
    during the study.
    18. Participation in a study of another investigational product within 28
    days prior to screening.
    19. Prior exposure to sparsentan.
    1. Il paziente presenta FSGS secondaria a un’altra condizione.
    2. Il paziente presenta risultati positivi a test sierologici di lesione glomerulare primaria o secondaria:
    3. Il paziente presenta un indicatore di recidiva dalla remissione completa
    4. Il paziente presenta un’anamnesi di diabete mellito di tipo 1, diabete mellito di tipo 2 non controllato (emoglobina A1c [HbA1c] > 8%) o glucosio nel sague a digiuno >180 mg/dL allo screening
    5. Il paziente è stato sottoposto a un qualsiasi trapianto d’organo, esclusi trapianti di cornea.
    6. Il paziente ha bisogno di uno qualsiasi dei farmaci concomitanti proibiti.
    7. Il paziente è stato trattato con rituximab, ciclofosfamide o abatacept entro =3 mesi prima dello screening. Se un paziente sta assumendo altri farmaci immunosoppressivi cronici, il dosaggio deve essere stabile da =1 mese prima della randomizzazione.
    8. Il paziente presenta un’anamnesi documentata di insufficienza cardiaca e/o precedente ricovero per insufficienza cardiaca o dispnea inspiegabile, ortopnea, dispnea parossistica notturna, ascite e/o edema periferico.
    9. Il paziente presenta una malattia cerebrovascolare clinicamente significativa e/o arteriopatia coronarica
    10. Il paziente presenta una malattia valvolare emodinamicamente significativa.
    11. Il paziente presenta ittero, epatite o malattia epatobiliare nota (esclusa la colelitiasi asintomatica), o livelli di transaminasi >2 volte il limite superiore dell’intervallo di normalità allo screening.
    12. Il paziente risulta positivo allo screening per il virus dell’immunodeficienza umana (HIV) o marcatori che indicano infezione
    acuta o cronica da virus dell’epatite B (HBV) o infezione da virus dell’epatite C (HCV)
    13. Il paziente presenta un’anamnesi di tumore maligno diverso da carcinoma cutaneo basocellulare o squamocellulare o
    carcinoma della cervice adeguatamente trattato nei 2 anni precedenti.
    14. Il paziente presenta un valore di ematocrito allo screening <27% o di emoglobina <9 g/dl.
    15. Il paziente presenta un valore di potassio allo screening >5,5 mEq/l.
    16. Il paziente ha un indice di massa corporea (IMC) >40
    17. Il paziente di sesso femminile è in stato di gravidanza o prevede di avviare una gravidanza nel corso dello studio, oppure sta allattando al seno.
    18. Il paziente ha partecipato a uno studio di un altro prodotto sperimentale nei 28 giorni precedenti lo screening
    19. Il paziente è stato precedentemente esposto a sparsentan
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy End points:
    The primary efficacy endpoint is the slope of eGFR.
    Safety End points:
    • Descriptive statistics will be used to summarize the safety data.
    L’endpoint primario di efficacia è la pendenza dell’eGFR valutata all’analisi finale.

    Endpoint di sicurezza:
    Valutazioni statistiche descrittive saranno utilizzate per riassumere i dati di sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 108
    Settimana 108
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include:
    -The percent change in eGFR.
    -The percent change in eGFR from baseline to 4 weeks post-treatment
    Gli endpoint secondari di efficacia comprendono:
    La variazione percentuale in eGFR.
    La variazione percentuale dell'eGFR dal basale a 4 settimane dopo il trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 108 and 112
    Settimana 108 e 112
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Hong Kong
    Korea, Democratic People's Republic of
    Korea, Republic of
    New Zealand
    South Africa
    Taiwan
    United States
    Belgium
    Croatia
    Czechia
    Denmark
    Estonia
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Spain
    Switzerland
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 300
    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)
    None. The Investigator should resume standard of care treatment, including treatment with appropriate medications, as deemed appropriate except irbesartan
    Nessuna. Lo sperimentatore dovrebbe riprendere il trattamento standard di cura, compreso il trattamento con farmaci appropriati, come ritenuto appropriato escluso irbesartan
    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 Decision2018-09-17
    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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