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    Summary
    EudraCT Number:2022-002400-20
    Sponsor's Protocol Code Number:81866
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-002400-20
    A.3Full title of the trial
    Feasibility of empagliflozin as treatment for idiopathic pulmonary arterial hypertension
    Haalbaarheidsstudie van empagliflozine als behandeling voor idiopathische pulmonale arteriële hypertensie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Feasibility of empagliflozin as treatment for pulmonary arterial hypertension (increase pressure in the pulmonary artery)
    Haalbaarheidsstudie van empagliflozine als behandeling voor pulmonale arteriële hypertensie (verhoogde druk in de longslagader)
    A.3.2Name or abbreviated title of the trial where available
    EMPHOWER proof-of-concept
    EMPHOWER bewijs van concept
    A.4.1Sponsor's protocol code number81866
    A.5.4Other Identifiers
    Name:Clinical Trials Information System (CTIS)Number:2022-501512-33-00
    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 SponsorAmsterdam UMC, location VUmc
    B.1.3.4CountryNetherlands
    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 supportPHAEDRA
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, location VUmc
    B.5.2Functional name of contact pointHarm Jan Bogaard
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117, Room number 5A-72
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.6E-mailhj.bogaard@amsterdamumc.nl
    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 Jardiance
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameEmpagliflozin
    D.3.2Product code EMEA/H/C/002677
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Idiopathic Pulmonary Arterial Hypertension
    Idiopathische pulmonale arteriële hypertensie
    E.1.1.1Medical condition in easily understood language
    increased pulmonary artery pressure of unknown cause
    verhoogde druk van de longslagader met onbekende oorzaak
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077731
    E.1.2Term Pulmonary hypertension WHO functional class I
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to determine whether conducting a randomized placebo-controlled clinical trial is feasible, safe for the patient and whether the treatment is well tolerated in patients with idiopathic pulmonary arterial hypertension.
    Het doel van het onderzoek is om te achterhalen of het uitvoeren van een gerandomiseerde placebo gecontroleerde klinische studie haalbaar, veilig is voor de patiënt en of de behandeling goed verdragen wordt door patienten met idiopathische pulmonale arteriële hypertensie
    E.2.2Secondary objectives of the trial
    Secondary objectives include change over time (from baseline to end of study follow up) of:

    • Right heart function measured using MRI
    • Right heart function measured using transthoracic ultrasound.
    • Blood safety biomarkers.
    • Urine biomarkers.
    • Functional class.
    • Six-Minute Walk Distance.
    • Quality of life.
    • Rechterhartfunctie gemeten met MRI:
    • Rechterhartfunctie gemeten met transthoracale echografie.
    • Bloedbiomarkers.
    • Biomarkers voor bloedveiligheid.
    • Urine-biomarkers.
    • Functionele klasse.
    • Zes minuten loopafstand.
    • Kwaliteit van het leven.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Diagnosis of idiopathic PAH
    3. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH with subtype idiopathic PAH. The documented RHC shows all of the following criteria:
    a. mPAP > 20 mmHg at rest
    b. Pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg at rest
    c. PVR ≥ 240 dyn·sec/cm5 (3 Wood units) at rest
    4. Symptomatic pulmonary hypertension classified as World Health Organization (WHO) functional class (FC) II, III or IV
    5. PAH therapy is at stable (per investigator) dose levels of standard of care (SoC) therapies for at least 90 days prior screening. SoC therapy refers to a therapy consisting of at least 1 agent from a list including: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist (SC/inhaled/PO).
    1. Leeftijd: ≥ 18 jaar
    2. Diagnose van idiopathische PAH
    3. Gedocumenteerde diagnostische rechterhartkatheterisatie (RHC) op elk moment voorafgaand aan screening ter bevestiging van de diagnose van WHO diagnostische pulmonale hypertensie Groep I: PAH met subtype idiopathische PAH. De gedocumenteerde RHC toont alle volgende criteria:
    a. mPAP > 20 mmHg in rust
    b. Pulmonale arterie wiggedruk (PAWP) of linkerventrikel einddiastolische druk (LVEDP) ≤ 15 mmHg in rust
    c. PVR ≥ 240 dyn sec/cm5 (3 WU) in rust
    4. Symptomatische pulmonale hypertensie geclassificeerd als World Health Organization (WHO) functionele klasse (FC) II, III of IV
    5. PAH-therapie is op stabiele (per onderzoeker) dosisniveaus van standaardzorg gedurende ten minste 90 dagen voorafgaand aan screening. SoC-therapie verwijst naar een therapie die bestaat uit ten minste één middel uit de: een endothelinereceptorantagonist (ERA), een fosfodiësterase 5 (PDE5)-remmer, een oplosbare guanylaatcyclasestimulator en/of een prostacycline-analoog of -receptoragonist ( SC/geïnhaleerd/PO).
    E.4Principal exclusion criteria
    1. Any subject who received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study. Patients participating in a purely observational trial will not be excluded
    2. Females of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 months), unable or unwillingly to either:
    a. Use highly effective methods of birth control according to the International Conference on harmonisation of pharmaceuticals for human use (ICH) that result in a low failure rate of less than 1% per year when used consistently and correctly 43. Highly effective methods include hormonal contraception (for example, birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation (having your tubes tied); or a partner with a vasectomy who has completed follow-up to confirm a successful procedure
    b. Have a negative pregnancy tests as verified by the investigator prior to starting study therapy and agrees to have an extra pregnancy test 8 weeks after start of the study
    3. Contraindication for CMR imaging as defined in the protocol of the Amsterdam UMC “Kwaliteitsdocument Cardiale MRI (Versie 1)”. The list of contra-indications includes: claustrophobia, ferromagnetic implants, implanted cardioverter defibrillator (ICD) or pacemaker (except for the MR conditional) and ball-in-cage mechanic heart valve.
    4. Impaired renal function, defined as eGFR < 30 mL/min/1.73 m2 (CKD-EPI) or
    requiring dialysis
    5. History of chronic severe (Child Pugh classification score >10, Appendix 1) or active liver disease defined as serums transaminases >5 x upper limit of normal (ULN) or bilirubin > 1.5 x ULN
    6. History of ketoacidosis
    7. Known allergy, intolerance or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
    8. Use of lithium compounds and being unable or unwillingly to increase the monitoring frequency of lithium levels
    9. Current or scheduled use of the following Uridine glucuronosyltransferase (UGT) inducers: phenytoin, rifampicin, carbamazepine, lamotrigine, ritonavir, efavirenz, tipranavir, phenobarbital, testosterone propionate and nelfinavir.
    10. Current or prior use of a SGLT-2 inhibitor
    11. Heart transplant recipient or listed for heart transplant
    12. Chronic pulmonary disease requiring home oxygen or steroid maintenance therapy
    13. Symptomatic hypotension and/or a systolic blood pressure (SBP) < 90 mmHg at screening
    14. Gastrointestinal (GI) surgery or GI disorder that could interfere with absorption of trial medication in the investigator’s opinion
    15. Presence of any other disease than pulmonary arterial hypertension with a life expectancy of <1 year in the investigator’s opinion
    16. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
    17. History of severe (previously required or prolonged patient hospitalization, resulted in persistent or marked disability/incapacity) or recurrent (≥2 infections in six months or ≥3 infections in one year) genital infections.
    18. History of severe hypoglycaemia (<40 - 30 mg/dL = <2.2 - 1.7 mmol/L), previous hospitalisation for hypoglycaemia or seizures attributed to hypoglycaemia
    19. Active solid or haematological malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin
    20. History or suspicion of inability to cooperate adequately
    21. Any condition that, in the investigator’s opinion, makes them an unreliable trial subject or unlikely to complete the trial
    1. Elke proefpersoon die binnen 1 maand voorafgaand aan de start van dit onderzoek enige onderzoeksmedicatie heeft gekregen of voor wie in de loop van dit onderzoek een ander onderzoeksgeneesmiddel is gepland. Patiënten die deelnemen aan een puur observationele studie worden niet uitgesloten
    2. Vrouwen die zwanger kunnen worden, gedefinieerd als een vruchtbare vrouw die: 1) geen hysterectomie of bilaterale ovariëctomie heeft ondergaan of 2) niet van nature postmenopauzaal is geweest (amenorroe na kankertherapie sluit de mogelijkheid om zwanger te worden niet uit) gedurende ten minste 24 opeenvolgende maanden (d.w.z. heeft op enig moment in de voorgaande 24 maanden een menstruatie gehad), niet in staat of onwillig om:
    a. Gebruik te maken zeer effectieve anticonceptiemethoden volgens de Internationale Conferentie over de harmonisatie van geneesmiddelen voor menselijk gebruik (ICH), die resulteren in een laag percentage mislukkingen van minder dan 1% per jaar bij consequent en correct gebruik 43. Zeer effectieve methoden zijn onder meer hormonale anticonceptie ( bijvoorbeeld anticonceptiepillen, injectie, implantaat, transdermale pleister, vaginale ring); spiraaltje (IUD); afbinden van de eileiders (met de tubae vastgebonden); of een partner die een vasectomie inclusief follow-up heeft voltooid om een ​​succesvolle procedure te bevestigen.
    b. Een negatieve zwangerschapstest hebben, zoals geverifieerd door de onderzoeker voordat de onderzoekstherapie wordt gestart en akkoord gaan met een extra zwangerschapstest 8 weken na de start van de studie
    3. Contra-indicatie voor MRI-beeldvorming zoals gedefinieerd in het protocol van het Amsterdam UMC “Kwaliteitsdocument Cardiale MRI (Versie 1)”. De lijst met contra-indicaties omvat: claustrofobie, ferromagnetische implantaten, geïmplanteerde cardioverter defibrillator (ICD) of pacemaker (behalve de MR-conditional) en mechanische bal-in-kooi hartklep.
    4. Verminderde nierfunctie, gedefinieerd als eGFR < 30 ml/min/1,73 m2 (CKD-EPI) of dialyse afhankelijk nierfalen
    5. Geschiedenis van chronisch ernstige (Child Pugh classificatiescore >10, bijlage 1) of actieve leverziekte gedefinieerd als serumtransaminasen >5 x bovengrens van normaal (ULN) of bilirubine > 1,5 x ULN
    6. Geschiedenis van ketoacidose
    7. Bekende allergie, intolerantie of overgevoeligheid voor empagliflozine of andere SGLT-2-remmers
    8. Gebruik van lithiumverbindingen en het niet kunnen of willen verhogen van de monitoringfrequentie van lithiumspiegels
    9. Huidig ​​of gepland gebruik van de volgende uridineglucuronosyltransferase (UGT)-inductoren: fenytoïne, rifampicine, carbamazepine, lamotrigine, ritonavir, efavirenz, tipranavir, fenobarbital, testosteronpropionaat en nelfinavir.
    10. Huidig ​​of eerder gebruik van een SGLT-2-remmer
    11. Ontvanger van een harttransplantatie of aangemeld voor harttransplantatie
    12. Chronische longziekte die thuiszuurstof of onderhoudstherapie met steroïden vereist
    13. Symptomatische hypotensie en/of een systolische bloeddruk (SBP) < 90 mmHg bij screening
    14. Gastro-intestinale (GI) chirurgie of GI-stoornis die volgens de onderzoeker de absorptie van onderzoeksmedicatie zou kunnen verstoren
    15. Aanwezigheid van een andere ziekte dan pulmonale arteriële hypertensie met een levensverwachting van <1 jaar naar het oordeel van de onderzoeker
    16. Vrouwen die zwanger zijn, borstvoeding geven of van plan zijn zwanger te worden tijdens het onderzoek
    17. Geschiedenis van ernstige (eerder vereiste of langdurige ziekenhuisopname van de patiënt, resulteerde in aanhoudende of duidelijke invaliditeit/ongeschiktheid) of terugkerende (≥2 infecties in zes maanden of ≥3 infecties in één jaar) genitale infecties.
    18. Voorgeschiedenis van ernstige hypoglykemie (<40 - 30 mg/dL = <2,2 - 1,7 mmol/L), eerdere ziekenhuisopname voor hypoglykemie of toevallen toegeschreven aan hypoglykemie
    19. Actieve vaste of hematologische maligniteit, met uitzondering van volledig uitgesneden of behandeld basaalcelcarcinoom, in-situ baarmoederhalscarcinoom of ≤ 2 plaveiselcelcarcinomen van de huid
    20. Geschiedenis of vermoeden van onvermogen om adequaat mee te werken
    21. Elke voorwaarde die, naar de mening van de onderzoeker, van hen een onbetrouwbare proefpersoon maakt of het onwaarschijnlijk maakt dat ze de proef zullen voltooien
    E.5 End points
    E.5.1Primary end point(s)
    The main study objectives and endpoints of this trial are to determine during a follow up of 12 weeks:
    • Tolerability. Endpoints: the number of patients who have to prematurely discontinue treatment due to intolerability or adverse events.
    • Feasibility: Endpoints: time needed to include all patients and number of patients needed to screen.
    • Safety. Endpoints: the number of adverse events (AEs), severe adverse events (SAEs), adverse event of special interest (AESI) and suspected unexpected serious adverse reactions (SUSARs).
    • Veiligheid: het aantal bijwerkingen (AE's), ernstige bijwerkingen (SAE's) en vermoedelijke onverwachte ernstige bijwerkingen (SUSAR's) tussen de eerste toediening van het geneesmiddel en 12 weken follow-up
    • Verdraagbaarheid: het aantal patiënten dat de studie voltooit zonder stopzetting van IMP
    • Haalbaarheid: Tijd die nodig is om alle patiënten op te nemen en het aantal patiënten dat nodig is om te screenen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tolerability and safety: from first drug administration to 12 weeks follow up
    Feasibility: From the start of screening to the last signed informed consent form
    Verdraagbaarheid en veiligheid: van eerste medicijntoediening tot 12 weken follow-up
    Haalbaarheid: vanaf het begin van de screening tot het laatst ondertekende formulier voor geïnformeerde toestemming
    E.5.2Secondary end point(s)
    • Right heart function measured using MRI: Endpoints: RVESVi, RVEDVi, RVEF, RV mass, LVSVi, LVEDVi, stroke volume and LVEF. Timepoints: baseline and week 12.
    • Right heart function measured using transthoracic ultrasound. Endpoints: Pulmonary artery acceleration time, early diastolic pulmonary regurgitation velocity, right ventricle fractional area change (RVFAC), right atrial area, S wave velocity, tricuspid annular plane systolic excursion (TAPSE), peak tricuspid valve regurgitation velocity (TRV) at rest, inferior cava diameter, estimated sPAP, estimated mPAP. Timepoints: baseline and week 12.
    • Blood biomarkers. Endpoints: Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) and bone morphogenetic protein receptor II (BMPR2) in peripheral blood mononuclear cells (PMBC) and Glycated hemoglobin (HbA1c). Timepoints: baseline and week 12.
    • Blood and urine safety biomarkers. Endpoints: Fasting glucose, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP) and creatinine in blood. Ketones, nitrites, leukocytes and glucose in urine test strip (dipstick). Timepoints: baseline, week 2, 6 and 12.
    • Functional class. Endpoint: World Health Organization Function Classification of Pulmonary Hypertension. Timepoints: baseline, week 2, 6 and 12.
    • Six-Minute Walk Distance. Endpoint: 6MWD. Timepoints: baseline and week 12.
    • Quality of life. Endpoint: EMPHASIS-10 and CAMPHOR questionnaires score. Timepoints: baseline and week 12.
    • Rechterhartfunctie gemeten met MRI: Eindpunten: Eindpunten: VESVi, RVEDVi, RVEF, RV mass, LVSVi, LVEDVi, stroke volume and LVEF. Tijdspunten: baseline en week 12.
    • Rechterhartfunctie gemeten met transthoracale echografie. Eindpunten: Pulmonary artery acceleration time, early diastolic pulmonary regurgitation velocity, right ventricle fractional area change (RVFAC), right atrial area, S wave velocity, tricuspid annular plane systolic excursion (TAPSE), peak tricuspid valve regurgitation velocity (TRV) at rest, inferior cava diameter, estimated sPAP, estimated mPAP. Tijdspunten: baseline en week 12.
    • Bloedbiomarkers. Eindpunten: Peroxisoom-proliferator-geactiveerde receptor gamma-co-activator 1-alfa (PGC-1α) en botmorfogenetische eiwitreceptor II (BMPR2) in perifere mononucleaire bloedcellen (PMBC) en geglyceerd hemoglobine (HbA1c). Tijdspunten: baseline en week 12.
    • Biomarkers in bloed en urine voor veiligheid. Eindpunten: Nuchter glucose, N-terminaal prohormoon van Brain Natriuretic Peptide (NT-proBNP) en geschatte glomerulaire filtratiesnelheid (eGFR). Ketonen, nitrieten, leukocyten en glucose in urine dipstick. Tijdspunten: baseline, week 2, 6 en 12.
    • Functionele klasse. Eindpunt: WHO functionele klasse voor pulmonale hypertensie. Tijdspunten: baseline, week 2, 6 en 12.
    • Zes minuten loopafstand. Eindpunt: 6MWD. Tijdspunten: baseline en week 12.
    • Kwaliteit van het leven. Eindpunt: EMPHASIS-10 en CAMPHOR-vragenlijsten score. Tijdspunten: baseline en week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    Zie E.5.2
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility of a larger randomized clinical trial
    Haalbaarheid van een grotere gerandomiseerde klinische studie
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    Week 12 (or end of treatment) + 4 weeks of follow up
    Week 12 (of einde behandeling) + 4 weken follow-up
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2023-02-10. Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with incurable diseases
    patiënten met ongeneeslijke ziekten
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 8
    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)
    At the discretion of the treating physician and the patients preferences, treatment with empagliflozin can be continued after trial completion
    Naar goeddunken van de behandelend arts en de voorkeuren van de patiënt kan de behandeling met empagliflozine worden voortgezet na voltooiing van het onderzoek
    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 Decision2023-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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