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    Summary
    EudraCT Number:2013-005571-40
    Sponsor's Protocol Code Number:9207
    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:2014-06-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-005571-40
    A.3Full title of the trial
    Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt
    Randomisierte Bewertung der kurzfristigen dualen Antithrombozytentherapie bei Patienten mit akutem Koronarsyndrom mit dem Dual-COMBO Therapie Stent behandelt
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt
    Randomisierte Bewertung der kurzfristigen dualen Antithrombozytentherapie bei Patienten mit akutem Koronarsyndrom mit dem Dual-COMBO Therapie Stent behandelt
    A.3.2Name or abbreviated title of the trial where available
    REDUCE
    REDUCE
    A.4.1Sponsor's protocol code number9207
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02118870
    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 SponsorDiagram B.V.
    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 supportOrbusNeich
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiagram B.V.
    B.5.2Functional name of contact pointJ. Klijn
    B.5.3 Address:
    B.5.3.1Street AddressDr. Stolteweg 96
    B.5.3.2Town/ cityZwolle
    B.5.3.3Post code8025 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310384262999
    B.5.5Fax number00310384262990
    B.5.6E-mailreduce.study@diagram-zwolle.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.2.5The 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 nameAspirin -Acetylsalicylsäure
    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 INNAcrtylsalicylic Acid
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor codeAspirine
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.2.5The 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 nameClopidogrel Hydrochlorid
    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 INNClopidogrel
    D.3.9.1CAS number 120202-65-5
    D.3.9.2Current sponsor codeClopidogrel
    D.3.9.3Other descriptive nameCLOPIDOGREL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB30779
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.2.5The 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 namePrasugrel
    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 INNPrasugrel
    D.3.9.1CAS number 150322-43-3
    D.3.9.2Current sponsor codePRASUGREL
    D.3.9.3Other descriptive namePrasugrel
    D.3.9.4EV Substance CodeSUB30236
    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: 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 Yes
    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 nameTicagrelor
    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 INNTicagrelor
    D.3.9.1CAS number 274693-27-
    D.3.9.2Current sponsor codeTicagrelor
    D.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    Acute coronary syndrome
    Patienten mit akutem Koronarsyndrom
    E.1.1.1Medical condition in easily understood language
    Occlusion/obstruction blood vessel of the heart
    Okklusion / Verschluss von Blutgefäßen des Herzens
    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 10064348
    E.1.2Term Non STEMI
    E.1.2System Organ Class 100000011652
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064346
    E.1.2Term STEMI
    E.1.2System Organ Class 100000011652
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002385
    E.1.2Term Angina pectoris unstable
    E.1.2System Organ Class 100000011626
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety of 3-months versus standard 12-months of DAPT
    Die Sicherheit von 3-Monaten gegenüber Standard-12-Monate DAPT zu vergleichen.
    E.2.2Secondary objectives of the trial
    Not applicable
    Nicht anwendbar
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient must be ≥18 years of age
    2. The patient has been diagnosed with STEMI, NSTEMI or UA
    3. The Patient is willing to comply with specified follow-up evaluations
    4. The Patient has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC)
    5. Successful COMBO stent implantation (TIMI 3 flow with residual stenosis < 20% based visual estimation), with no clinical adverse event during hospitalization (Death, stent thrombosis (ST), stroke, target vessel revascularisation (TVR), bleeding (BARC II, III, V))
    1. Der Patient muss ≥ 18 Jahre alt sein
    2. Patienten mit STEMI, NSTEMI oder UA diagnostiziert
    3.Der Patient erklärt sich bereit an spezifische Nachuntersuchungen teilzunehemen.
    4. Der Patient ist über die Art der Studie informiert.
    Der Patient ist mit den Bestimmungen der Studie einverstanden und hat eine genehmigte,schriftliche Einverständniserklärung von der zuständigen Gremien Medizinischen-Ethik-Kommission (MEC), Institutional Review Board (IRB), oder der Humanforschungsethikkommission (HREC) bereitgestellt.
    5.Erfolgreiche COMBO Stent-Implantation (TIMI 3 Strom mit Rest Stenose <20% aufgrund visuelle Einschätzung), ohne klinische Nebenwirkung während des Krankenhausaufenthaltes (Tod, Stentthrombose (ST), Schlaganfall, Revaskularisierung der Zielgefäße (TVR), Blutungen (BARC II , III, V))
    E.4Principal exclusion criteria
    1. Patients presenting with cardiogenic shock
    2. Patients with recent major bleeding complications or contraindication to DAPT, such as:
    a) Hypersensitivity to Aspirin, Clopidogrel, Prasugrel or Ticagrelor
    b) Need for oral anticoagulation
    c) History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia) or refusal of blood transfusions
    d) History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
    e) Stroke or transient ischemic attack within the past 6 months or any permanent residual neurologic defect
    f) Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 weeks
    g) Recent history or known current platelet count <100 000 cells/mm3 or hemoglobin <10 g/dL
    h) An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
    3. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
    4. Planned intervention of another lesion (target vessel or non-target vessel) after index hospital discharge
    5. Any revascularization performed within index hospitalization with other stents than COMBO
    6. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
    7. Patients requiring permanent DAPT due to comorbidities
    8. Patient has received any organ transplant or is on a waiting list for any organ transplant
    9. Life expectancy of less than 2 years
    10. Pregnancy or intention to become pregnant during the course of the trial
    11. Any significant medical or mental condition, which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study
    12. Currently participating in another investigational drug or device study
    13. Patients who have been treated with another DES within 9 months prior to the index procedure
    1. Patienten mit kardiogenem Schock
    2. Patienten mit kürzlichen schweren Blutungskomplikationen oder Kontraindikationen zu DAPT wie:
    a) Überempfindlichkeit gegen Aspirin, Clopidogrel, Prasugrel oder Ticagrelor
    b) Benötigen von orale Antikoagulation
    c) Bekannte Blutungsneigungen oder bekannte
    Gerinnungsstörung (einschließlich Heparin-induzierte
    Thrombozytopenie) oder die Verweigerung von
    Bluttransfusionen
    d) Bekannte mit intrazerebralen Massen, Aneurysma,
    arteriovenöse Fehlbildungen oder Hämorrhagischen
    Schlaganfall.
    e) Schlaganfall oder TIA innerhalb der letzten 6 Monate oder
    einem dauerhaften neurologischen Restdefekt
    f ) Magen-oder urogenitalen Blutung innerhalb der letzten 2
    Monate oder größere Operation innerhalb von 6 Wochen
    g) Kürzlich entdeckte oder bekannte
    Stromthrombozytenzahl von <100 000 Zellen/mm3 oder
    Hämoglobin <10 g / dL
    h) Ein geplanter chirurgischen Eingriff die Unterbrechung der Thienopyridine während der ersten 12 Monate nach der
    Einschreibung erforderlich machen würden.
    3. Gleichzeitiger geplante nötige Herzchirurgie
    (z. B.
    Klappenoperation oder Resektion von Aorten-oder
    linksventrikulären Aneurysma etc.)
    4. Geplante Intervention eines anderen Läsion (Zielgefäß
    oder Nichtzielgefäßes) nach dem
    Krankenhausentlassung
    5. Jede Revaskularisierung innerhalb des Index
    Krankenhausaufenthaltes mit anderen Stents als COMBO
    Stents durchgeführt.
    6. Mögliche Nichteinhaltung an die Anforderungen im
    Studienprotokoll (vor allem die ärztliche Behandlung) oder die Nachuntersuchungen / Besuche.
    7. Patienten bedürften permanente DAPT durch
    Komorbidität
    8. Patienten die eine Organtransplantation erhalten haben oder auf
    eine Warteliste für Organtransplantation stehen.
    9. Lebenserwartung von weniger als 2 Jahren
    10. Schwangerschaft oder die Absicht im Verlauf der Studie
    schwanger zu werden
    11. Jede wesentliche medizinische oder psychische
    Erkrankung, die nach Ansicht des Forschers die
    optimalen Beteiligung des Patienten an der Studie
    beeinträchtigen könnte.
    12. Derzeitige Teilname an einer anderen Studie
    13. Patienten die mit einem anderen DES innerhalb von 9
    Monaten vor dem Index-Verfahren behandelt worden
    sind.
    E.5 End points
    E.5.1Primary end point(s)
    Composite of all cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, bleeding (BARC II, III, V) at 360 days
    Zusammensetzung von Gesamtmortalität, Myokardinfarkt (MI), Stentthrombose (ST), Schlaganfall (stroke), Revaskularisation des Zielgefäßes (TVR) oder Blutungen (BARC II, III, V) nach 360 Tagen
    E.5.1.1Timepoint(s) of evaluation of this end point
    360 days
    Nach 360 Tagen
    E.5.2Secondary end point(s)
    - Prespecified landmark analysis of Primary Endpoint from 90 to 360 days
    - Bleeding (BARC II, III, V) at 360 ays
    - All cause mortality, MI, ST, stroke, bleeding (BARC II, III, V) at 720 days
    - All cause mortality, MI, ST, stroke at 360 and 720 days
    - Cardiac Mortality at 360 and 720 days
    - Any MI at 360 and 720 days
    - ST at 360 and 720 days
    - Repeat revascularization at 360 and 720 days
    - Time to event analysis primary endpoint
    -Analyse von Vorgegebenen Landmarken von primären Endpunkt auf, von 90 bis 360 Tagen.

    -Blutungen (BARC II, III und V) nach 360 Tagen.

    -Gesamtmortalität, Myokardinfarkt, Stentthrombose, Schlaganfall und Blutung(BARC II, III und V) nach 720 Tagen.

    - Gesamtmortalität, Myokardinfarkt, Stentthrombose und Schlaganfall nach 360 und 720 Tagen.

    -Kardialen Mortalität nach 360 und 720 Tagen.

    -Jeder Myokard Infarkt nach 360 und 720 Tagen.
    -Stentthrombose nach 360 und 720 Tagen.
    -Wiederholte Revaskularisation nach 360 und 720 Tagen.

    -Zeit-Event-Analyse des primären Endpunkts
    E.5.2.1Timepoint(s) of evaluation of this end point
    - time to event primary endpoint
    - 360 days
    - 720 days
    - Zeit zum Ereignis primären Endpunkt.
    - Nach 360 Tagen.
    - Nach 720 Tagen.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    Die Medikamentegabe dauert länger.
    Duration of administration of drugs is longer
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    Germany
    Hong Kong
    Hungary
    Indonesia
    Italy
    Malaysia
    Netherlands
    Poland
    Singapore
    Thailand
    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 last visit of the last patient
    Der letze Besuch des letzen Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 1500
    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
    Keine
    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 Decision2014-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-11
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