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    Summary
    EudraCT Number:2021-006577-30
    Sponsor's Protocol Code Number:D4326C00003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-006577-30
    A.3Full title of the trial
    A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose-ranging Study to Assess Efficacy, Safety, and Tolerability of the Combination of Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy Versus Placebo in Participants with Cirrhosis with Features of Portal Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Zibotentan and Dapagliflozin combination, EvAluated in Liver cirrhosis (ZEAL study)
    A.3.2Name or abbreviated title of the trial where available
    ZEAL
    A.4.1Sponsor's protocol code numberD4326C00003
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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 Yes
    D.2.1.1.1Trade name Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDapagliflozin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDapagliflozin propanediol
    D.3.9.1CAS number 960404-48-2
    D.3.9.2Current sponsor codeDapagliflozin propanediol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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 nameZibotentan capsule
    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 INNZibotentan
    D.3.9.1CAS number 186497-07-04
    D.3.9.2Current sponsor codeZibotentan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 nameZibotentan capsule
    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 INNZibotentan
    D.3.9.1CAS number 186497-07-04
    D.3.9.2Current sponsor codeZibotentan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.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 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 nameZibotentan capsule
    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 INNZibotentan
    D.3.9.1CAS number 186497-07-04
    D.3.9.2Current sponsor codeZibotentan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Liver cirrhosis with features of portal hypertension.
    E.1.1.1Medical condition in easily understood language
    Liver cirrhosis with features of increased pressure in portal veins.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10024667
    E.1.2Term Liver cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A main objective:
    To evaluate the change from baseline in HVPG on zibotentan and dapagliflozin in combination versus placebo.

    Part B main objective:
    To evaluate the proportion of participants achieving at least 20% decrease in HVPG or a reduction to or below 12 mmHg in HVPG on zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo.
    E.2.2Secondary objectives of the trial
    Part A secondary objectives- to evaluate:
    • the change from baseline in HVPG
    • the proportion of participants achieving HVPG < 10 mmHg or a reduction in HVPG of ≥ 1.5 mmHg
    • the effect on change in body weight
    • the effect on accumulated additional loop-diuretic equivalents use
    • the effect on body water volumes and body fat mass
    • the effect on changes in office-based systolic and diastolic blood pressure
    Of zibotentan and dapagliflozin in combination versus placebo

    Part B secondary objectives- to evaluate:
    • the change from baseline in HVPG
    • the effect on change in body weight
    • the effect on accumulated additional loop-diuretic equivalents use
    • the effect on body water volumes and body fat mass
    • the effect on changes in office-based systolic and diastolic blood pressure
    Of zibotentan and dapagliflozin in combination and dapagliflozin monotherapy versus placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study principal inclusion criteria:
    Participant must be aged 18 years and ≤ 80 years of age at the time of signing the
    informed consent.

    Part A participants who have the following:
    (a) Clinical and/or histological diagnosis of cirrhosis with either (i) features of portal
    hypertension or (ii) liver stiffness ≥ 21 kPa.
    (b) MELD score < 15.
    (c) Child-Pugh score ≤ 6.
    (d) No clinically evident ascites
    (e) No evidence of worsening of hepatic function (eg, no clinically significant change in
    signs, symptoms, or laboratory parameters of hepatic disease status) within the last
    month prior to dosing, as determined by the investigator or usual practitioner.
    (f) HVPG recording of good enough quality as judged by a central reader.

    Part B participants who have the following:
    (a) Clinical and/or histological diagnosis of cirrhosis with features of portal
    hypertension.
    (b) MELD score < 15.
    (c) Child-Pugh score < 10.
    (d) No ascites or ascites up to grade 2 without change in diuretic treatment within the last
    month prior to first dose and no paracentesis within the last month or planned
    paracentesis in the next 4 months at screening.
    (e) No evidence of worsening of hepatic function (eg, no clinically significant change in
    signs, symptoms, or laboratory parameters of hepatic disease status) within the last
    month prior to dosing, as determined by the investigator or usual practitioner.
    (f) HVPG recording of good enough quality as judged by a central reader.
    E.4Principal exclusion criteria
    Study principal exclusion criteria:
    a) Any evidence of a clinically significant disease which in the investigator’s opinion makes it undesirable for the participant to participate in the study.
    b) Liver cirrhosis caused by chronic cholestatic liver disease
    c) ALT or AST ≥ 150 U/L and/or total bilirubin ≥ 3 × ULN
    d) Acute liver injury caused by drug toxicity or by an infection.
    e) Any history of hepatocellular carcinoma.
    f) Liver transplant or expected liver transplantation within 6 months of screening.
    g) History of TIPS or a planned TIPS within 6 months from enrolment into the study.
    h) Active treatment for HCV within the last 1 year or HBV antiviral therapy for less than 1 year.
    i) Participants with T1DM.

    Medical Conditions (Part A only)
    a) INR > 1.5.
    b) Serum/plasma levels of albumin ≤ 35 g/L.
    c) Platelet count < 75 × 109/L.
    d) History of ascites
    e) History of hepatic hydrothorax
    f) History of portopulmonary syndrome
    g) History of hepatic encephalopathy
    h) History of variceal haemorrhage
    i) History of acute kidney injury
    j) History of heart failure, including high output heart failure (eg, due to hyperthyroidism or Paget’s disease)

    Medical Conditions (Part B only)
    a) INR > 1.7.
    b) Serum/plasma levels of albumin ≤ 28 g/L.
    c) Platelet count < 50 × /109L.
    d) Acute kidney injury within 3 months of screening.
    e) History of encephalopathy of West Haven grade 2 or higher.
    f) History of variceal haemorrhage within 6 months prior to screening.
    g) NYHA functional heart failure class III or IV or with unstable heart failure requiring hospitalisation for optimisation of heart failure treatment and who are not yet stable on heart failure therapy within 6 months prior to screening.
    h) Heart failure due to cardiomyopathies that would primarily require specific other treatment: eg, cardiomyopathy due to pericardial disease, amyloidosis or other infiltrative diseases, cardiomyopathy related to congenital heart disease, primary hypertrophic cardiomyopathy, cardiomyopathy related to toxic or infective conditions (ie, chemotherapy, infective myocarditis, septic cardiomyopathy).
    i) High output heart failure (eg, due to hyperthyroidism or Paget’s disease).
    j) Heart failure due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement.
    E.5 End points
    E.5.1Primary end point(s)
    Part A Primary End Point:
    Absolute change in HVPG from baseline to Week 6.

    Part B Primary End Point:
    HVPG response, where a responder is defined as at least 20% decrease or a reduction to or below
    12 mmHg in HVPG from baseline to Week 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A Primary End Point Week 6

    Part B Primary End Point: Week 6
    E.5.2Secondary end point(s)
    Part A Secondary End Points:
    1 Percent change in HVPG from baseline to Week 6.

    2 HVPG response, where a responder is defined as HVPG < 10 mmHg or a reduction in HVPG of ≥ 1.5 mmHg from baseline to Week 6.

    3 Evaluation of change in body weight (kg) over time course of study (Home-based balance)
    Percentage and absolute change from baseline in body weight at Week 6. (Office balance)

    4 Percentage and absolute change in accumulated dosage of loop-diuretic equivalents use from baseline to Week 6.

    5 Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6.
    Change in total body fat mass from baseline to Week 6.

    6 Change in systolic and diastolic blood pressure from baseline to Week 6.

    Part B Secondary End Points:
    1 Percentage and absolute change in HVPG from baseline to Week 6.

    2 Evaluation of change in body weight (kg) over time course of study. (Home-based balance)
    Percentage and absolute change from baseline in body weight at Week 6 and Week 16. (Office balance)

    3 Percentage and absolute change in accumulated dosage of loop-diuretic equivalents use from baseline to Week 6 and Week 16.

    4 Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6 and Week 16.
    Change in total body fat mass from baseline to Week 6 and Week 16

    5 Change in systolic and diastolic blood pressure from baseline to Week 6 and Week 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A Secondary End Points:

    1 Week 6

    2 Week 6

    3 Week 6

    4 Week 6

    5 Week 6

    6 Week 6

    Part B Secondary End Points:

    1 Week 6

    2 Week 6 and Week 16

    3 Week 6 and Week 16

    4 Week 6 and Week 16

    5 Week 6 and Week 16
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Austria
    Spain
    Switzerland
    Germany
    Belgium
    Denmark
    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 end of Part A is defined as the date of the last visit of the last participant in the Part A study.

    The end of Part B is defined as the date of the last visit of the last participant in the Part B study.

    All results will be presented by treatment group and overall (where specified) for Part A and Part B separately, with descriptive statistics appropriate to the nature of the variables.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days24
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 140
    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.
    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 Decision2022-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-14
    P. End of Trial
    P.End of Trial StatusOngoing
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