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    Summary
    EudraCT Number:2012-005422-30
    Sponsor's Protocol Code Number:AIO-KRK-0212
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-08
    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 - PEI
    A.2EudraCT number2012-005422-30
    A.3Full title of the trial
    Randomized Phase II study for evaluation of efficacy and safety of maintenance treatment with 5-FU/FA plus panitumumab vs. 5-FU/FA alone after prior induction treatment with mFOLFOX6 plus panitumumab and re-induction with mFOLFOX6 plus panitumumab in case of progression for first-line treatment of patients with metastatic colorectal cancer
    Randomisierte Phase-II-Studie über Induktionsbehandlung mit mFOLFOX6 plus Panitumumab gefolgt von Erhaltungsbehandlung mit 5-FU/FA plus Panitumumab versus 5-FU/FA allein und Re-Induktion mit mFOLFOX plus Panitumumab im Falle des Progresses für die Erstlinienbehandlung von Patienten mit metstasiertem Kolorektalkarzinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Phase II study for evaluation of efficacy and safety of maintenance treatment with 5-FU/FA plus panitumumab vs. 5-FU/FA alone after prior induction treatment with mFOLFOX6 plus panitumumab and re-induction with mFOLFOX6 plus panitumumab in case of progression for first-line treatment of patients with metastatic colorectal cancer
    Randomisierte Phase-II-Studie über Induktionsbehandlung mit mFOLFOX6 plus Panitumumab gefolgt von Erhaltungsbehandlung mit 5-FU/FA plus Panitumumab versus 5-FU/FA allein und Re-Induktion mit mFOLFOX plus Panitumumab im Falle des Progresses für die Erstlinienbehandlung von Patienten mit metstasiertem Kolorektalkarzinom
    A.4.1Sponsor's protocol code numberAIO-KRK-0212
    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 SponsorAIO Studien gGmbH
    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 supportAIO-Studien-gGmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAIO-Studien-gGmbH
    B.5.2Functional name of contact pointDr. Martin Mänz
    B.5.3 Address:
    B.5.3.1Street AddressKuno-Fischer-Str. 8
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14057
    B.5.3.4CountryGermany
    B.5.4Telephone number0049308145340
    B.5.5Fax number00493032293226
    B.5.6E-mailMartin.maenz@aio-studien-ggmbh.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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeEGFR-targeted monoclonal antibody
    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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeEGFR-targeted monoclonal antibody
    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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeEGFR-targeted monoclonal antibody
    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
    Metastatic colorectal cancer
    Metastasiertes kolorektales Karzinom
    E.1.1.1Medical condition in easily understood language
    Metastatic colorectal cancer
    Metastasiertes kolorektales Karzinom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of panitumumab plus 5-FU/FA as maintenance after an induction treatment of 12 weeks with mFOLFOX6 plus panitumumab in the first-line treatment of KRAS wild type metastatic colorectal cancer patients compared to 5-FU/FA maintenance alone in terms of progression-free survival
    Untersuchung der Wirksamkeit von Panitumumab plus 5-FU/FA als Erhaltungstherapie nach einer 12-wöchigen Induktionstherapie mit mFOLFOX6 plus Panitumumab in der Erstlinientherapie von Patienten mit metastasiertem Kolorektalkarzinom (KRAS-Wildtyp) im Hinblick auf das progressionsfreie Überleben im Vergleich zu einer Erhaltungstherapie mit 5-FU/FA allein
    E.2.2Secondary objectives of the trial
    To compare maintenance arms with respect to:
    - Time from randomization until failure of treatment strategy (death/progression)
    - Progression-free survival of re-induction
    - Objective response after 12 weeks of induction chemotherapy
    - Objective best response during maintenance and re-induction
    - Overall survival measured from time of randomization and from time of registration
    - Safety
    - Health and skin related Quality of life
    Vergleich der Studienarme der Erhaltungsphase im Hinblick auf:
    - Zeit von der Randomisierung bis zum Versagen der Behandlungsstrategie (Tod des Patienten oder Tumorprogression)
    - Progressionsfreies Überleben während der Re-Rnduktionsphase
    - Objektives Tumoransprechen nach 12 Wochen Induktions-Chemotherapie
    - Objektiv bestes Tumoransprechen während Erhaltungsphase und Re-Induktion
    - Gesamtüberleben gemessen ab dem Zeitpunkt der Randomisierung sowie vom Zeitpunkt der Registrierung
    - Sicherheit
    - Lebensqualität in Bezug auf den allgemeinen Gesundheitszustand und den Hautzustand
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed written informed consent
    - Male or female >/= 18 years
    - Histologically proven metastatic colorectal cancer
    - Molecular testing showing KRAS wild type in colorectal carcinoma cells
    - Life expectancy > 12 weeks
    - At least one measurable lesion according to RECIST 1.1
    - Adequate bone marrow, liver, kidney, organ and metabolic function
    - ECOG perfomance status 0-1
    - Woman of child-bearing potential must have a negative pregnancy test
    - Schriftliche Einverständniserklärung
    - Männer oder Frauen >/= 18 Jahre
    - histologisch nachgewiesenes metastasiertes kolorektales Karzinom
    - KRAS-Wildtyp in der Mutationsanalyse der Zellen des kolorektalen Karzinoms
    - Lebenserwartung > 12 Wochen
    - Mindestens eine messbare Läsion gemäß RECIST 1.1
    - Adäquate Knochenmark-, Leber- und Nieren-, Organ- und Stoffwechselfunktion
    - ECOG Performance-Status 0-1
    - Frauen im gebärfähigen Alter müssen einen negativen Schwangerschaftstest haben
    E.4Principal exclusion criteria
    - Previous treatment for colorectal cancer in the metastatic setting with the exception that patients with urgent need of immediate treatment (high tumor load, symptoms) may have received one cycle of any FOLFOX regimen (no capecitabine!) in case of yet unconfirmed RAS status
    - Previous EGFR-targeting therapy
    -Complete or partial DPD-deficiency. DPD deficiency can be evaluated by measuring the uracil plasmalevel or by genotyping of the DPD-coding gene (DPYD).
    - < 6 months after end of adjuvant therapy (previous
    chemoradiation for rectal cancer is accepted for inclusion into
    the trial and does not account as adjuvant therapy)
    - Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
    - Chronic inflammatory bowel disease
    - Peripheral polyneuropathy >/= NCI-CTC V 4.03 grade 2
    - Other previous malignancies with the exception of a history of previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or other curatively treated malignat disease without recurrance after at least 5 years of follow-up
    - Significant disease that, in the investigator´s opinion, would exclude the patient from the study
    - History of cardiac deseases, defined as:
    ° Congestive heart failure > New York Aheart Assiciation (NYHA) class 2
    ° Active coronary artery disease (myocardial infarction more than 6 months prior to start of study treatment is allowed)
    ° Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
    ° Uncontrolled hypertension (defined as blood preasure >/= 160 mmHg systolic and/or >/= 90 mmHg diastolic on medication)
    - Patients with interstitial lung disease, e. g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
    - Known HIV, hepatitis B or C infection
    - Known hypertensitivity reaction to any of the study components
    - Radiotherapy, major surgery or any investigational drug 21 days before registration
    - Pregnancy or lactation or planning to be pregnant during treatment and within 6 months after the end of treatment
    - Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for at least an additional 6 months after the end of treatment
    - Known alcohol or drug abuse
    - Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
    - Vorausgegangene Behandlung des metastasierten kolorektalen Karzinoms mit der Ausnahme, dass Patienten im Falle dringenden Behandlungsdrucks (hohe Tumorlast, Symptome) und noch unbestätigtem RAS Status einen Zyklus eines FOLFOX Regimes (kein Capecitabin!) erhalten haben dürfen.
    - Vorausgegangene zielgerichtete EGFR-Therapie
    -Kompletter oder partieller DPD-Mangel. DPD-Mangel kann durch Messung des Uracil Plasmalevels oder Typisierung des DPD-codierenden Gens (DPYD) evaluiert werden.
    - Ende der adjuvanten Therapie < 6 Monate zurückliegend
    - Bekannte Gehinmetastasen, mit Ausnahme adäquat (chirurgisch oder strahlentherapeutisch) behandelter Metastasen ohne Hinweis auf Progression und mit einer stabilen neurologischen Situation ohne Gabe von Antikonvulsiva und Steroiden
    - Chronisch-entzündliche Darmerkrankung
    - Periphere Neuropolypathie >/= NCI-CTCAE Grad 2 (Version 4.03)
    - Andere frühere maligne Erkrankungen, mit Ausnahme der Anamnese eines vorausgegangenen Basalzell-Karzinoms der Haut oder eines präinvasiven Zervixkarzinoms oder einer anderen kurativ behandelten malignen Erkrankung ohne Rezidiv nach mindestens 5 Jahren Nachbeobachtung
    - Schwere Erkrankung, die nach Ansicht des Prüfarztes den Patienten von einer Studienteilnahme ausschließt
    - Anamnestische Herzerkrankung, definiert als:
    ° Kongestive Herzinsuffizienz > New York Heart Association (NYHA) Klasse 2
    ° Aktive koronare Herzerkrankung (kein Ausschlusskriterium ist ein Myokardinfarkt mehr als 6 Monate vor Beginn der Behandlungsphase der Studie)
    ° Kardiale Arrhythmien, die einer antiarrhytmischen Therapie bedürfen (Betablocker oder Digoxin sind erlaubt)
    ° Unkontrollierter Bluthochdruck (definiert als Blutdruck >/= 160 mmHg systolisch und/oder >/= 90 mmHg diastolisch unter entsprechender Medikation)
    - Patienten mit interstitieller Lungenerkrankung, z. B. Pneumonitis, pulmonale Fibrose oder Nachweis einer interstitiellen Lungenerkrankung im Thorax-CT der Eingangsuntersuchung
    - Bekannte Infektion mit HIV, Hepatitis B oder C
    - Bekannte Überempfindlichkeit gegen eine der im Rahmen der Studie verabreichten Arzneimittelkomponenten
    - Strahlentherapie, größere Operation oder Einnahme/Anwendung einer experimentellen Substanz innerhalb der letzten 21 Tage vor Einschluss in die Studie
    - Schwangerschaft, Stillzeit oder geplante Schwangerschaft während der Behandlungsphase und innerhalb von 6 Monaten nach Behandlungsende
    - Teilnehmer (männlich oder weiblich) ist nicht willens, während und bis zu 6 Monaten nach der Behandlung eine hochwirksame Verhütungsmethode (gemäß Standard der Einrichtung) zu verwenden
    - Bekannter Alkohol- oder Drogenmissbrauch
    - Jegliche Umstände, die instabil sind oder die Sicherheit des Patienten und seine Compliance im Rahmen der Studie gefährden könnten
    E.5 End points
    E.5.1Primary end point(s)
    Progession-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first
    Progessionsfreies Überleben während der Erhaltungstherapie, definiert als Zeit von der Randomisierung bis zur Krankheitsprogression oder bis zum Tod, je nachdem, welches Ereignis zuerst eintritt
    E.5.2Secondary end point(s)
    - Time from randomization until failure of treatment strategy (death/progression)
    - Progression-free survival of re-induction
    - Objective response after 12 weeks of induction chemotherapy
    - Objective best response during maintenance and re-induction
    - Overall survival measured from time of randomization and from time of registration
    - Safety
    - Health and skin related Quality of life
    - Zeit von der Randomisierung bis zum Versagen der Behandlungstrategie (Tod/Progression)
    - Progressionsfreies Überleben während der Re-Induktion
    - Objetives Ansprechen nach 12 Wochen Induktions-Chemotherapie
    - Objektiv bestes Ansprechen während der Erhaltungstherapie und der Re-Induktion
    - Gesamtüberleben gemessen ab dem Zeitpunkt der Randomisierung sowie ab dem Zeitpunkt der Registrierung
    - Sicherheit
    - Lebensqualität bezogen auf den allgemeinen Gesundheitszustand und den Hauszustand
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned95
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state400
    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)
    After completion of the study at routine follow-up (EOT), patients will generally be treated at the discretion of the investigator according to medical routine.
    Die Weiterbehandlung der Patienten nach Ausscheiden aus der Studie liegt im Ermessen des Prüfarztes und ist im Prüfplan nicht näher spezifiziert.
    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 Decision2013-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-17
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