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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-001090-16
    Sponsor's Protocol Code Number:2017003001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-001090-16
    A.3Full title of the trial
    A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria: a Randomized Double Blind 6-Weeks Cross-Over Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study will assess the effects of dapagliflozin (a drug that is used in patients with Type 2 Diabetes) on lowering the level of urine protein in patients with non-diabetic kidney disease.
    A.3.2Name or abbreviated title of the trial where available
    DIAMOND
    A.4.1Sponsor's protocol code number2017003001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03190694
    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 SponsorUniversity Medical Center Groningen
    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 supportAstraZeneca
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointHiddo Jan Lambers Heerspink
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1; PO Box 30 001
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503617859NA
    B.5.5Fax number+31503617889NA
    B.5.6E-mailh.j.lambers.heerspink@umcg.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 Forxiga 10mg Tablet
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameForxiga
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Chronic kidney disease
    Chronische nierziekte
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease. A disease to the kidneys which results in chronic kidney function loss.
    Chronische nierziekte. Een ziekte aan de nieren, waardoor de nieren gedurende een langere periode minder goed werken.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary:
    • To assess the change baseline in 24-hr proteinuria with dapagliflozin for six weeks relative to placebo treatment in patients with non-diabetic kidney disease and proteinuria > 500 mg/day on stable ACEi or ARB treatment.
    Belangrijkste studiedoel:
    - Onderzoeken of behandeling met dapagliflozine gedurende 6 weken leidt tot een verandering in 24-uurs proteïnurie vanaf baseline, vergeleken met behandeling met placebo voor 6 weken, in een groep patiënten met niet-diabetische nierziekte en proteïnurie > 500 mg/dag die een stabiele dosis ACE-remmers of Angiotensine-receptor-antagonisten innemen.
    E.2.2Secondary objectives of the trial
    Secondary:
    • To assess the effect of dapagliflozin 10 mg/d compared to placebo on Glomerular Filtration Rate (GFR) using iohexol clearance.
    • To assess the effect of dapagliflozin 10 mg/d compared to placebo on systolic/diastolic blood pressure
    • To assess the effect of dapagliflozin 10 mg/d compared to placebo on body weight
    • To assess the effect of dapagliflozin 10 mg/d on selected neurohormones/biomarkers:
    o Hormones of the RAAS (plasma and urine)
    o Natriuretic peptides
    o Urinary adenosine
    o Co-peptin
    o Immunoglobulin G (plasma and urine)
    • To characterize the safety of dapagliflozin vs. placebo by determining the number of hypoglycemic episodes between groups, and serious adverse events.
    Overige studiedoelen:
    - Onderzoeken wat de effecten zijn van dapagliflozine 10 mg/dag vergeleken met placebo op GFR, gemeten d.m.v. iohexol-klaring
    - Onderzoeken wat de effecten zijn van dapagliflozine 10 mg/dag vergeleken met placebo op de systolische- en diastolische bloeddruk
    - Onderzoeken wat de effecten zijn van dapagliflozine 10 mg/dag vergeleken met placebo op het gewicht
    - Onderzoeken wat de effecten zijn van dapagliflozine 10 mg/dag vergeleken met placebo met betrekking tot bepaalde geselecteerde biomarkers/neurohormonen:
    o Hormonen in plasma en urine die betrekking hebben op het RAAS-systeem
    o Verschillende natriuretische peptiden (ANP, BNP)
    o Adenosine (urine)
    o Co-peptine
    o Immunoglobuline G (uit plasma en urine)
    - Het onderzoeken van de veiligheid van dapagliflozine therapie vergeleken met placebo bij deze doelgroep, door o.a. te kijken naar het aantal hypoglycemische epidosen en door de serieuze bijwerkingen in beeld te brengen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18 and ≤75 years
    - Urinary protein excretion > 500 mg/g and ≤ 3500 mg/g in a 24hour urine collection
    - eGFR ≥ 25 mL/min/1.73m2
    - On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
    - Willing to sign informed consent
    - Women of Child-Bearing Potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
    - WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
    - Women must not be breast-feeding
    - Leeftijd ≥18 en ≤75 jaar
    - Proteïnurie van > 500mg/g en ≤ 3500 mg/g in 24-uurs urine
    - eGFR ≥ 25 mL/min/1.73m2
    - Stabiele dosering van een ACE-remmer of Angiotensine receptor antagonist voor ten minste 4 weken vóór start van de randomisatie
    - Mensen die het informed consent willen tekenen
    - Vrouwen in de vruchtbare leeftijd moeten een geaccepteerde anti-conceptie methode gebruiken, om het risico op het ontstaan van een zwangerschap te minimaliseren gedurende de studie tot 4 weken na de inname van het laatste studiegerelateerd medicijn.
    - Vrouwen in de vruchtbare leeftijd dienen een negatieve zwangerschapstest te hebben (negatieve serum- of urine test) 0 tot 72 uur vóór de toediening van een studiegerelateerd medicijn.
    - Vrouwen mogen geen borstvoeding geven
    E.4Principal exclusion criteria
    - Diagnosis of type 1 or type 2 diabetes mellitus
    - Urinary protein excretion > 3500 mg/day
    - Peripheral Vascular Disease
    - Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis
    - Indication for immunosuppressants as per the treating physician’s judgment.
    - Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
    - Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
    - Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
    o History of active inflammatory bowel disease within the last six months;
    o Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
    o Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
    o Pancreatic injury or pancreatitis within the last six months;
    o Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
    o Evidence of urinary obstruction of difficulty in voiding at screening
    - History of severe hypersensitivity or contraindications to dapagliflozin
    - History of hypersensitivity or contraindications to iodinated contrast media
    - Subject who may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data
    - Participation in any clinical investigation within 3 months prior to initial dosing.
    - Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing.
    - History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
    - History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
    - Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
    - Pregnancy or breastfeeding
    - WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
    - Mensen met type 1 of type 2 diabetes mellitus
    - Een urine-eiwit excretie van > 3500 mg/dag
    - Perifere vasculaire ziekte
    - Gediagnosticeerd met: een autosomaal dominante polycysteuze nierziekte of een autosomaal recessieve polycysteuze nierziekte, lupus nefritis, of ANCA-geassocieerde vasculitis
    - Indicatie voor behandeling met immunosuppressiva, volgens het oordeel van de behandelend arts
    - Deelnemers die in de 6 maanden voorafgaand aan de studie nog voor primaire of secundaire nierziekten zijn behandeld met cytotoxische middelen, immunosuppressieve therapie, of andere vormen van immunotherapie
    - Een actieve maligniteit, afgezien van een behandeld plaveiselcelcarcinoom of basaalcelcarcinoom van de huid
    - Het hebben van een aandoening of ziekte, of het gebruiken van een medicijn, wat invloed kan hebben op de absorptie, distributie, het metabolisme, of de excretie van een van de studiegerelateerde medicijnen, waaronder (maar niet gelimiteerd tot) het volgende:
    o Een actieve inflammatoire darmziekte in de laatste 6 maanden
    o Een grote operatieve ingreep betreffende het maagdarmstelsel, zoals een maagresectie, een gastro-enterostomie of een darmresectie.
    o Een ulcus van de maag of het duodenum, of rectaal bloedverlies in de laatste 6 maanden
    o Pancreatitis of pancreasletsel in de laatste 6 maanden
    o Aanwijzingen voor een leverfunctiestoornis, zoals één van de volgende afwijkingen: ALT of AST-waarden 3x boven de normaalwaarden op het moment van screening, een hepatische encefalopathie, oesofagus varices, of een portocavale shunt in de voorgeschiedenis.
    o Een mogelijke obstructie van de urinewegen of moeite met urineren op het moment van screening.
    - Contra-indicaties voor dapagliflozine of een overgevoeligheid voor dapagliflozine
    - Contra-indicaties of overgevoeligheid voor jodium houdend contrastmiddel
    - Een verhoogd risico op dehydratie of hypovolumie wat invloed kan hebben op de beoordeling van de effectiviteit of de veiligheid
    - Deelname aan een klinisch onderzoek in de 3 maanden voorafgaand aan de eerste gift van het studiegerelateerde medicijn
    - 400ml of meer bloedverlies in de 8 weken voorafgaand aan de eerste gift van het studiegerelateerde medicijn.
    - Een voorgeschiedenis van drugs- of alcoholmisbruik in de 12 maanden voorafgaand aan de eerste gift van het studiegerelateerde medicijn, of tijdens de screening vergaarde aanvullende diagnostiek wijzend op dergelijk misbruik.
    - Mensen die moeite hebben met therapietrouw of die het studie protocol niet willen naleven.
    - Het hebben van een medische aandoening of ziekte waardoor deelname aan de studie kan leiden tot een verhoogd risico, of waardoor het voldoen aan de studie-eisen of het afmaken van de studie bemoeilijkt wordt.
    - Zwangerschap of het geven van borstvoeding
    - Vrouwen in de vruchtbare levensfase die een kinderwens hebben of geen anti-conceptiemiddelen willen gebruiken gedurende de studieperiode tot aan 4 weken na de laatste gift van een studiegerelateerd medicijn
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameters/endpoints: Change in 24-hr proteinuria
    Verandering in 24-uurs proteïnurie vanaf baseline tot het einde van een 6-weeks durende behandelperiode.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (dag 1) and at the end of the six weeks treatment period (week 6), of eacht treatment period
    Bij de start (dag 1) en aan het eind van de zes week behandelperiode. Dit geldt voor elke behandelperiode.
    E.5.2Secondary end point(s)
    Secondary study parameters/endpoints (if applicable)
    • Glomerular Filtration Rate measured with iohexol
    • Systolic/diastolic blood pressure
    • Neurohormones/biomarkers
    o Hormones of the RAAS (renin, aldosterone in plasma and urine)
    o Natriuretic Peptides
    o Urinary adenosine
    o Co-peptin
    o Immunoglobulin G

    Other study parameters (if applicable)
    • Number of hypoglycaemic episodes
    • Serious Adverse Events
    • Drug related adverse events (causality to investigational product assessed by research physician).
    - Verandering in GFR, gemeten d.m.v. iohexol
    - Verandering in systolische- en diastolische bloeddruk
    - Verandering in neurohormonen en biomarkers
    - Verandering in RAAS-hormonen
    - Verandering in natriuretische peptiden
    - Verandering in urine adenosine
    - Verandering in Co-peptide
    - Verandering in immunoglobuline G

    - Aantal episoden van hypoglycemie
    - Aantal en soort ernstige bijwerkingen
    - Aantal en soort medicijngerelateerde bijwerkingen, bepaald door de onderzoeksarts
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary study parameters/endpoints (if applicable)
    • Glomerular Filtration Rate measured with iohexol
    --> at the start of eacht treatment period (day 1) and at the end of each treatment period (week 6). And also six weeks after the second treatment period (week 24).
    • Systolic/diastolic blood pressure
    --> day 1,week 3 and 6 (last day on treatment) of each treatment period
    • Neurohormones/biomarkers --> day 1,week 3 and 6 (last day on treatment) of each treatment period.

    Other study parameters --> during the whole study period
    • Number of hypoglycaemic episodes
    • Serious Adverse Events
    • Drug related adverse events (causality to investigational product assessed by research physician).
    - Verandering in GFR, gemeten d.m.v. iohexol
    --> start (dag 1) en aan het eind van de behandelperiode (week 6). En daarnaast aan het eind van de tweede behandelperiode (week 24)
    - Verandering in systolische- en diastolische bloeddruk
    --> dag 1, week 3 en week 6 van welke behandelperiode
    - Verandering in neurohormonen en biomarkers
    --> dag 1, week 3, week 6 van elke behandelperiode.

    Gedurende de hele studie:
    - Aantal episoden van hypoglycemie
    - Aantal en soort ernstige bijwerkingen
    - Aantal en soort medicijngerelateerde bijwerkingen, bepaald door de onderzoeksarts
    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 Yes
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned3
    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 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
    Canada
    Malaysia
    Netherlands
    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
    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 months7
    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 months7
    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: 13
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 53
    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)
    During the study and after the study the patient will visit his/her own physician (at the outpatient clinic and/or the general practitioner) according to the routine terms of patient care.
    Gedurende de studie en na de studie zal de patiënt door zijn/haar eigen arts (specialist en/of huisarts) gezien worden, zoals normaal gesproken ook de afspraken gepland staan.
    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 Decision2017-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-07
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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