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    Summary
    EudraCT Number:2019-000919-85
    Sponsor's Protocol Code Number:DP13C201
    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:2021-01-28
    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 number2019-000919-85
    A.3Full title of the trial
    DP13 – A Phase II Study in Patients with Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of the Aldosterone Synthase Inhibitor, DP13, over an 8-week Treatment Period
    DP13 – Studio di Fase II in pazienti con aldosteronismo primario per valutare l’efficacia, la sicurezza e la tollerabilità dell’inibitore della sintesi di aldosterone, DP13, in un periodo di trattamento della durata di 8 settimane
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in Patients with Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of the Aldosterone Synthase Inhibitor, DP13, over an 8-week Treatment Period
    Studio in pazienti con aldosteronismo primario per valutare l’efficacia, la sicurezza e la tollerabilità dell’inibitore della sintesi di aldosterone, DP13, in un periodo di trattamento della durata di 8 settimane
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberDP13C201
    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 SponsorDAMIAN Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportDAMIAN Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDAMIAN Pharma AG
    B.5.2Functional name of contact point-
    B.5.3 Address:
    B.5.3.1Street AddressHaltli 6
    B.5.3.2Town/ cityWalchwil
    B.5.3.3Post code6318
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41415004232
    B.5.5Fax number+41417606667
    B.5.6E-mailchristoph.schumacher@damianpharma.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDP13
    D.3.2Product code [DP13]
    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 INNFADROZOLE
    D.3.9.1CAS number 102676-47-1
    D.3.9.2Current sponsor codeDP13
    D.3.9.3Other descriptive name5R-(+)-Fadrozole-Enantiomer Phosphate
    D.3.9.4EV Substance CodeSUB07497MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 No
    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 nameDP13
    D.3.2Product code [DP13]
    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 INNFADROZOLE
    D.3.9.1CAS number 102676-47-1
    D.3.9.2Current sponsor codeDP13
    D.3.9.3Other descriptive name5R-(+)-Fadrozole-Enantiomer Phosphate
    D.3.9.4EV Substance CodeSUB07497MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 No
    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 nameDP13
    D.3.2Product code [DP13]
    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 INNFADROZOLE
    D.3.9.1CAS number 102676-47-1
    D.3.9.2Current sponsor codeDP13
    D.3.9.3Other descriptive name5R-(+)-Fadrozole-Enantiomer Phosphate
    D.3.9.4EV Substance CodeSUB07497MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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 Aldosteronism
    Aldosteronismo primario
    E.1.1.1Medical condition in easily understood language
    Primary Aldosteronism
    Aldosteronismo primario
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001656
    E.1.2Term Aldosteronism
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the efficacy of daily oral DP13 treatment (all dose arms combined) to decrease the plasma aldosterone-to-renin ratio (ARR) from baseline in patients with primary aldosteronism (PA)
    • To determine the efficacy of daily oral DP13 treatment (all dose arms combined) to reduce 24-hour ambulatory systolic blood pressure (aSBP) from baseline in patients with PA
    • Determinare l’efficacia del trattamento giornaliero con DP13 per via orale nella diminuzione del rapporto plasmatico aldosterone-renina (Aldosterone-to-Renin Ratio – ARR) rispetto al basale in pazienti con aldosteronismo primario (Primary Aldosteronism – PA)
    • Determinare l’efficacia del trattamento giornaliero con DP13 per via orale nella riduzione della pressione arteriosa sistolica ambulatoriale sulle 24 ore (ambulatory Systolic Blood Pressure – aSBP) rispetto al basale in pazienti con PA
    E.2.2Secondary objectives of the trial
    • To determine the safety and tolerability of DP13 treatment in patients with PA
    • To determine the efficacy of daily oral DP13 (all dose arms combined) to reduce office systolic blood pressure (oSBP) from baseline in patients with PA
    • To determine the efficacy to decrease the plasma ARR from baseline in each individual dose arm
    • To determine the efficacy of daily oral DP13 to reduce oSPB and 24-hour aSBP from baseline in each individual dose arm
    • To determine the DP13 dose-dependent efficacy to decrease the plasma ARR from baseline in patients with PA
    • To determine the DP13 dose-dependent efficacy to reduce oSBP and 24-hour aSBP from baseline in patients with PA
    • Determinare la sicurezza e la tollerabilità del trattamento con DP13 in pazienti con PA
    • Determinare l’efficacia della somministrazione giornaliera per via orale di DP13 (tutti i gruppi di dosaggio combinati) nella riduzione della pressione arteriosa sistolica misurata presso lo studio medico (office Systolic Blood Pressure – oSBP) rispetto al basale in pazienti con PA
    • Determinare l’efficacia nella diminuzione dell’ARR plasmatico rispetto al basale in ogni singolo gruppo di trattamento
    • Determinare l’efficacia della somministrazione giornaliera per via orale di DP13 nella riduzione di oSPB e aSBP sulle 24 ore rispetto al basale in ogni singolo gruppo di trattamento
    • Determinare l’efficacia dose-dipendente di DP13 nella diminuzione dell’ARR plasmatico rispetto al basale in pazienti con PA
    • Determinare l’efficacia dose-dipendente di DP13 nella riduzione di oSBP e aSBP sulle 24 ore rispetto al basale in pazienti con PA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ARR of =40 with plasma aldosterone concentration (PAC) =15 ng/dL and plasma renin activity (PRA) <1.0 ng/mL/h. A prescreening ARR of =3.7 results by using plasma renin concentration (PRC) <15 mU/L instead of PRA as denominator.
    • A IV saline loading test (2 litres of 0.9% saline infused over 4 hours) with resulting PAC >7.0 ng/dL after infusion. For patients at risk for volume expansion, a captopril test (50 mg captopril peroral) can be used instead with resulting ARR >30 and PAC >11 ng/dL (respectively ARR >2.4 using PRC in mU/L instead of PRA as denominator).
    • Systolic blood pressure >145 mmHg by automatic office blood pressure measurement and in presence of hypertension control therapy (doxazosin 1 - 8 mg QD and, only if necessary, verapamil slow release 40 - 120 mg BID or amlodipine 2.5 - 10 mg QD).
    •Estimated glomerular filtration rate (eGFR) =45 mL/min/1.73 m2 using the MDRD-4 GFR equation

    Formal eligibility verification after implementation of a doseadjusted blood pressure control therapy with a documented case review process led by the Central Review Board is mandatory prior to final enrolment.
    • ARR =40 con concentrazione plasmatica di aldosterone (Plasma Aldosterone Concentration – PAC) =15 ng/dL e attività plasmatica della renina (Plasma Renin Activity – PRA) <1.0 ng/mL/h. Un valore pre-screening di ARR =3.7 risulta utilizzando la concentrazione plasmatica di renina (Plasma Renin Concentration – PRC) <15 mU/L invece della PRA come denominatore.
    • Un test di carico con soluzione salina per via endovenosa (2 litri di soluzione salina allo 0.9% infusi nel corso di 4 ore) con PAC risultante >7.0 ng/dL dopo l’infusione. Per i pazienti a rischio di espansione del volume, può essere utilizzato in sostituzione un test con captopril (50 mg di captopril per via orale) con ARR risultante >30 e PAC >11 ng/dL (rispettivamente ARR >2.4 utilizzando PRC in mU/L invece di PRA come denominatore).
    • Pressione arteriosa sistolica >145 mmHg con misurazione automatica della pressione arteriosa presso lo studio medico e in presenza di terapia per il controllo dell’ipertensione (doxazosina 1-8 mg QD e, solo se necessario, verapamil a lento rilascio 40-120 mg BID o amlodipina 2.5 -10 mg QD).
    • Velocità di filtrazione glomerulare stimata (estimated Glomerular Filtration Rate – eGFR) =45 mL/min/1.73 m2 utilizzando l’equazione MDRD-4 GFR.

    Prima dell’arruolamento finale, è obbligatoria la verifica formale dell’eleggibilità dopo l’implementazione di una terapia per il controllo dell’ipertensione con aggiustamento della dose con processo documentato di revisione del caso condotto dal Comitato di Revisione Centralizzata (Central Review Board).
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they satisfy any of the following criteria:
    1. Patients with PA and:
    1.1. treated with spironolactone within 2 months of enrolment
    1.2. hyperkalaemia of >5.0 mmol/L
    1.3. prolonged QT intervals with QTc of >500 msec using Bazett’s formula

    2. Patients with PA and:
    2.1. sitting office systolic office blood pressure (oSBP) >190 mmHg
    and/or
    2.2. sitting office diastolic office blood pressure (oDBP) >110 mmHg
    and if applicable
    2.3. in presence of non-interfering hypertension control therapy consisting of doxazosin (1
    – 8 mg QD) as first-line medication and, if necessary, only verapamil slow release (40
    – 120 mg BID) or amlodipine (2.5 – 10 mg QD) at adjusted and fixed doses

    3. Patients with PA who will not consent to special contraception measures during the entire
    study period, specifically
    3.1. female patients not withdrawing oral contraceptives >2 weeks prior to enrolment
    3.2. female patients not using intrauterine devices (IUD), diaphragm, sponge with
    spermicide or adhering to abstinence
    3.3. male patients not using condoms or not adhering to abstinence and not refraining from
    sperm donation

    4. Patients with PA and a medical history of:
    4.1. cerebro- and cardiovascular events (stroke, myocardial infarction, percutaneous
    transluminal coronary angioplasty) within 6 months of study enrolment
    4.2. gastrointestinal tract surgeries or malabsorption syndromes
    4.3. chronic use of oral or parenteral corticosteroids

    5. Patients with PA who:
    5.1. participated in any clinical study within 6 weeks
    5.2. suffered a significant blood loss within <2 months
    5.3. had a significant illness within <2 weeks
    5.4. are pregnant or breastfeeding
    5.5. are unable to follow all study procedures
    I pazienti che soddisfano uno qualsiasi dei seguenti criteri saranno esclusi dallo studio:
    1. Pazienti con PA e:
    1.1. trattati con spironolattone nei 2 mesi precedenti l’arruolamento
    1.2. Iperkaliemia >5.0 mmol/L
    1.3. Prolungamento degli intervalli QT con QTc >500 msec utilizzando la formula di Bazett
    2. Pazienti con PA e:
    2.1. Pressione arteriosa sistolica in posizione seduta misurata ambulatorialmente (office Sistolic Blood Pressure – oSBP) >190 mmHg
    e/o
    2.2. Pressione arteriosa diastolica in posizione seduta misurata ambulatorialmente (office Diastolic Blood Pressure – oDBP) >110 mmHg
    e se applicabile
    2.3. In presenza di terapia di controllo per ipertensione non interferente consistente di doxazosina (1 – 8 mg QD) come trattamento di prima linea e, se necessario, solo verapamil a lento rilascio (40 – 120 mg BID) o amlodipina (2.5 – 10 mg QD) a dosi aggiustate e fisse
    3. Pazienti con PA che non acconsentono all’utilizzo di misure contraccettive speciali durante l’intero periodo di studio, in modo specifico:
    3.1. Pazienti di sesso femminile che non sospendono l’uso di contraccettivi orali > 2 settimane prima dell’arruolamento
    3.2. Pazienti di sesso femminile che non utilizzano dispositivi intrauterini (IUD), diaframma, spugna con spermicida o che non aderiscono all’astinenza
    3.3. Pazienti di sesso maschile che non utilizzano preservativi o che non aderiscono all’astinenza e che non si astengono dalla donazione di sperma
    4. Pazienti con PA e anamnesi di:
    4.1. Eventi cerebro- e cardiovascolari (ictus, infarto miocardico, angioplastica coronarica percutanea transluminale) nei 6 mesi precedenti l’arruolamento nello studio
    4.2. Interventi chirurgici al tratto gastrointenstinale o sindromi da malassorbimento
    4.3. Utilizzo cronico di corticosteroidi per via orale o parenterale
    5. Pazienti con PA che:
    5.1. Hanno partecipato a qualsiasi studio clinico nelle precedenti 6 settimane
    5.2. Hanno subito una perdita di sangue significativa nei <2 mesi precedenti
    5.3 Hanno avuto una malattia significativa nelle <2 settimane precedenti
    5.4. Sono in gravidanza o allattamento
    5.5. Non sono in grado di seguire tutte le procedure di studio
    E.5 End points
    E.5.1Primary end point(s)
    • Change in the plasma ARR for all dose arms combined
    • Change in mean 24-hour aSBP for all dose arms combined
    • Variazione in ARR plasmatico per tutti i gruppi di trattamento combinati
    • Variazione di aSBP sulle 24 ore media per tutti i gruppi di trattamento combinati
    E.5.1.1Timepoint(s) of evaluation of this end point
    • from baseline (Day 1) to the end of the 8-week daily oral DP13 treatment period (Day 56)
    • from baseline (Day 1) to the end of the 8-week daily oral DP13 treatment period (Day 56)
    • Dal basale (Giorno 1) al termine del periodo di trattamento giornaliero della durata di 8 settimane con DP13 per via orale (Giorno 56)
    • Dal basale (Giorno 1) al termine del periodo di trattamento giornaliero della durata di 8 settimane con DP13 per via orale (Giorno 56)
    E.5.2Secondary end point(s)
    • Occurrence of treatment-emergent adverse events (TEAE) and serious
    adverse events (SAE)
    • Change in oSBP for all dose arms combined
    • Change in the plasma ARR in each individual dose arm
    • Change in 24-hour aSBP in each individual dose arm
    • Change in oSBP from baseline in each individual dose arm
    • Insorgenza di eventi avversi emergenti dal trattamento (Treatment-Emergent Adverse Events - TEAE) ed eventi avversi seri
    • Variazioni di oSBP per tutti i gruppi di trattamento combinati
    • Variazioni in ARR plasmatico in ciascun singolo gruppo di trattamento
    • Variazione di aSBP sulle 24 ore in ciascun singolo gruppo di trattamento
    • Variazione di oSBP rispetto al basale in ciascun singolo gruppo di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    • over the entire study duration
    • from baseline (Day 1) to the end of the 8-week daily oral DP13 treatment period (Day 56)
    • from baseline (Day 1) to biweekly office visits (week 2, week 4, week 6) and to the end of the 8-week daily oral DP13 treatment period (Day 56)
    • from baseline (Day 1) to biweekly office visits (week 2, week 4, week 6) and to the end of the 8-week daily oral DP13 treatment period (Day 56)
    • from baseline (Day 1) to biweekly office visits (week 2, week 4, week 6) and to the end of the 8-week daily oral DP13 treatment period (Day 56)
    • Per tutta la durata dello studio
    • Dal basale (Giorno 1) al termine del periodo di trattamento della durata di 8 settimane con DP13 per via orale (Giorno 56)
    • Dal basale (Giorno 1) alle visite ambulatoriali bisettimanali (settimana 2, settimana 4, settimana 6) e al termine del periodo di trattamento della durata di 8 settimane con DP13 per via orale (Giorno 56)
    • Dal basale (Giorno 1) alle visite ambulatoriali bisettimanali (settimana 2, settimana 4, settimana 6) e al termine del periodo di trattamento della durata di 8 settimane con DP13 per via orale (Giorno 56)
    • Dal basale (Giorno 1) alle visite ambulatoriali bisettimanali (settimana 2, settimana 4, settimana 6) e al termine del periodo di trattamento della durata di 8 settimane con DP13 per via orale (Giorno 56)
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Periodo con PL in singolo cieco
    Placebo single-blind period
    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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Germany
    Italy
    Switzerland
    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
    LVLS
    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 months4
    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 months4
    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.1.1.1In 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 36
    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)
    Standard of care
    Terapia Standard
    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 Decision2019-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-01
    P. End of Trial
    P.End of Trial StatusOngoing
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