Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43853   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-020015-36
    Sponsor's Protocol Code Number:Nauck-DZBL-2010-1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-020015-36
    A.3Full title of the trial
    „Feed-Back“-Suppression der Nahrungs-induzierten GLP-1-Sekretion durch Erhöhung des intakten GLP-1 unter DPP-4-Inhibition: Ein Vergleich von Vildagliptin und Sitagliptin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    „Feed-Back“-Suppression der Nahrungs-induzierten
    GLP-1-Sekretion durch Erhöhung des intakten GLP-1 unter DPP-4-Inhibition: Ein Vergleich von Vildagliptin und Sitagliptin
    A.4.1Sponsor's protocol code numberNauck-DZBL-2010-1
    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 SponsorDiabeteszentrum Bad Lauterberg
    B.1.3.4CountryGermany
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiabeteszentrum Bad Lauterberg
    B.5.2Functional name of contact pointStudienzentrum
    B.5.3 Address:
    B.5.3.1Street AddressKirchberg 21
    B.5.3.2Town/ cityBad Lauterberg im Harz
    B.5.3.3Post code37431
    B.5.3.4CountryGermany
    B.5.4Telephone number0049552481265
    B.5.5Fax number00490552481752
    B.5.6E-mailbaranov@diabeteszentrum.de
    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 Januvia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & Co. Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    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 INNSITAGLIPTIN
    D.3.9.1CAS number 790712-60-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name Galvus
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical form 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 INNVILDAGLIPTIN
    D.3.9.1CAS number 274901-16-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name Januvia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Co. Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    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 INNSITAGLIPTIN
    D.3.9.1CAS number 790712-60-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Diabetes mellitus Type II
    E.1.1.1Medical condition in easily understood language
    Diabetes mellitus Type II
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Die „Feed-Back“-Inhibition der nahrungsinduzierten GLP-1-Sekretion ist durch Vildagliptin ausgeprägter als durch Sitagliptin.
    E.2.2Secondary objectives of the trial
    Die Reduktion des Glukagons nach Stimulation durch eine Testmahlzeit ist durch Vildagliptin ausgeprägter als durch Sitagliptin, und Vildagliptin hat einen größeren Effekt (als Sitagliptin) auf die basale (Nüchtern-) Sekretion und die durch einen intravenösen Glukose-Bolus induzierte Sekretion von Insulin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Männer und Frauen, zwischen ≥ 30 und ≤ 75 Jahre , mit Diabetes mellitus Typ 2 gemäß der Definition American Diabetes Association seit mehr als einem Jahr
    • Body Mass Index zwischen 20,0 und 40,0 kg/m² (jeweils einschließlich)
    • HbA1c ≤ 8,5 %
    • Behandelt entweder mit: Diät / körperlicher Aktivität allein oder Metformin ≥ 1500 mg täglich als Dauertherapie (seit mind. 6 Wochen vor Start der 1. Behandlungsperiode).
    • Normale Vitalzeichen nach 10 min Ruhe
    95 mmHg < systolischer Blutdruck < 160 mmHg;
    45 mmHg < diastolischer Blutdruck < 100 mmHg;
    45/min. < Pulsfrequenz < 100/min
    • Geschätzte GFR ≥ 60 ml/min.
    • Gebärfähige Frauen (weniger als 2 Jahre postmenopausal oder nicht seit mindestens 3 Monaten chirurgisch sterilisiert) müssen einen negativen Serum -β-HCG–Schwangerschaftstest beim Screening und negative Urin-β-HCG–Schwangerschaftstests an den Tagen 1 der Behandlungsperioden 1, 2 und 3 aufweisen, sowie eine hochwirksame Methode der Schwangerschaftsverhütung verwenden.
    • Bei postmenopausalen Frauen, die weniger als 2 Jahre postmenopausal sind, und die nicht gleichzeitig seit mindestens 3 Monaten chirurgisch sterilisiert sind, wird der hormonelle Status bestimmt (FSH > 30 IU/L). Wird dieser Wert nicht erreicht, werden diese Frauen als gebärfähig eingestuft.
    • Schriftliche Einverständniserklärung nach umfassender Aufklärung vor jeglicher studienspezifischer Aktivität
    E.4Principal exclusion criteria
    • Antidiabetische medikamentöse Therapie in den letzten 6 Wochen vor Beginn der Behandlungsperiode 1, mit Ausnahme von Metformin
    • Frühere oder gegenwärtige klinisch bedeutsame kardiovaskuläre pulmonale, gastrointestinale, hepatische, renale, metabolische (außer Diabetes mellitus Typ 2), hämatologische, neoplastische, neurologische, psychiatrische, ophthalmologische, gynäkologische (bei Frauen) Erkrankung oder Systemerkrankung, bekannte HIV-Infektion oder HIV-Krankheit, oder Zeichen akuter Erkrankung allgemein.
    • Schwerwiegende Erkrankungen, die die Ergebnisse der geplanten Untersuchung beeinflussen würden oder mit einem erhöhten Risiko für die teilnehmenden Patienten verbunden wären.
    • Symptome einer klinisch bedeutsamen Erkrankung in den letzten drei Monaten, die nach Einschätzung eines Studienarztes mit den Zielen der Studie interferieren könnte
    • Herzinsuffizienz der funktionellen Klassen III und IV nach der Einteilung der New York Heart Association (NYHA)
    • Gebrauch anderer Arzneimittel in den letzten drei Monaten vor Beginn der Studie (Erster Tag der Behandlungsphase 1) mit Ausnahme von Schilddrüsenhormonen, Lipidsenkern und antihypertensiver Medikation und bei Frauen mit Ausnahme einer hormonellen Kontrazeption oder einer postmenopausalen Hormonersatztherapie
    • Blutverlust (> 300 ml, jegliche Ursache) innerhalb 3 Monate vor Einschluss in die Studie oder ein Hämoglobinwert < 11,0 mg/dl
    • Erhöhte Leberwerte (ALT, AST, Bilirubin, y-GT), höher als das 3-fache der oberen Grenze des Normbereichs.
    • Geschätzte GFR < 60 ml/min.
    • Teilnahme an einer Studie mit einem Prüfmedikament in den letzten drei Monaten, oder derzeit in der Ausschlussperiode nach einer vorausgegangenen Studie befindlich, sofern die einschlägigen Bestimmungen dies fordern.
    • Gegenwärtiges oder anamnestisches Vorliegen einer Arzneimittelallergie oder einer klinisch bedeutsamen allergischen Erkrankung, nach Einschätzung eines Prüfarztes.
    • Bekannte Überempfindlichkeit gegenüber DPP-4-Inhibitoren (neben Vildagliptin oder Sitagliptin auch Saxagliptin als kommerziell verfügbar sowie die derzeit nicht zugelassenen Substanzen Linagliptin, Dutogliptin, Gemigliptin und Alogliptin)
    • Arzneimittel- oder Alkoholmissbrauch (Alkoholkonsum > 40 g / Tag)
    • Schwangerschaft (definiert als positiver β-HCG-Blut-Test bei Frauen), Stillzeit
    • Patienten, die nach Beurteilung des Prüfarztes im Rahmen der Studie wahrscheinlich nicht kooperieren werden oder aufgrund einer Sprachbarriere oder wegen Limitationen der geistigen Leistungsfähigkeit nicht kooperieren können oder im Notfall nicht erreichbar sind.
    E.5 End points
    E.5.1Primary end point(s)
    GLP-1-„Feed-Back“-Inhibition: Prozentuale Reduktion der totalen GLP-1-Sekretion (bestimmt als integrierte Anstiege über „Baseline“-Werte, 0-240 min)
    E.5.1.1Timepoint(s) of evaluation of this end point
    unter Behandlung mit Vildagliptin bzw. Sitagliptin relativ zu Placebo jeweils nach einer Testmahlzeit (Tag 1) am letzten Tag der Behandlungsperiode
    E.5.2Secondary end point(s)
    1. Unterschiede der Glukagonkonzentration während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung.2. Unterschiede der Insulinsekretion (Insulin, C-Peptid, Insulinsekretionsraten)
    2. Unterschiede der Insulinsekretion (Insulin, C-Peptid, Insulinsekretionsraten) während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung.
    3. Unterschiede der Insulinsekretion (Insulin, C-Peptid, Insulinsekretionsraten) unter basalen Bedingungen am Tag nach dem Mahlzeittest, Stimulation durch intravenöse Glukose-Bolus-Injektion unter Vildagliptin- und Sitagliptin-Behandlung, separat nach erster Phase der Insulinsekretion (0-10 min) und zweiter Phase der Insulinsekretion (10 min und folgende)
    4. Unterschiede der Glukoseanstiege während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung.
    5. Unterschiede der GIP-Konzentrationen (total = Sekretion; intakt = biologisch wirksame Form) und „Feedback“-Inhibition der K-Zell-Sekretion während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung.
    6. Sicherheit und Verträglichkeit
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung
    2. während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung
    3. unter basalen Bedingungen am Tag nach dem Mahlzeittest; unter Vildagliptin- und Sitagliptin-Behandlung nach erster Phase der Insulinsekretion (0-10 min) und zweiter Phase der Insulinsekretion (10 min und folgende)
    4. während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung
    5. während der Testmahlzeiten unter Vildagliptin- und Sitagliptin-Behandlung.
    6. at any timepoint
    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 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 Yes
    E.8.1.7.1Other trial design description
    Stratum A (metformin naïve) and B (treated with metformin)
    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 trial3
    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 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
    n/a
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 2011-02-07. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    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)
    n/a
    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 Decision2011-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-31
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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.

    European Medicines Agency © 1995-Tue Apr 23 08:13:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA