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    Summary
    EudraCT Number:2013-003886-33
    Sponsor's Protocol Code Number:MH-148
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-20
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-003886-33
    A.3Full title of the trial
    PHASE IV, DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, TWO-ARM CROSSOVER STUDY TO COMPARE 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF DOTAREM® AND 0.05 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF DOTAREM® IN MAGNETIC RESONANCE IMAGING (MRI)
    OF THE BRAIN (BENEFIT)
    DVOJITĚ ZASLEPENÉ, MULTICENTRICKÉ, RANDOMIZOVANÉ,
    PŘEKŘÍŽENÉ KLINICKÉ HODNOCENÍ FÁZE IV S DVĚMA RAMENY S CÍLEM POROVNAT PŘÍPRAVKY MULTIHANCE® V DÁVCE 0,1 mmol/kg A DOTAREM® V DÁVCE 0,1 mmol/kg A MULTIHANCE® V DÁVCE 0,05 mmol/kg A DOTAREM® V DÁVCE 0,1 mmol/kg PŘI VYŠETŘENÍ MOZKU MAGNETICKOU REZONANCÍ (KLINICKÉ HODNOCENÍ BENEFIT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Multihance and Dotarem in brain tumor(s)
    Srovnání dvou kontrastních látek Multihance a Dotarem při vyšetření nádoru mozku magnetickou rezonancí
    A.3.2Name or abbreviated title of the trial where available
    Crossover comparison of Multihance and Dotarem in brain tumor(s)
    řekřížené porovnání přípravků Multihance a Dotarem při vyšetření mozkového nádoru
    A.4.1Sponsor's protocol code numberMH-148
    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 SponsorBracco Imaging S.p.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBracco Imaging S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBracco Suisse SA
    B.5.2Functional name of contact pointPatricia Caillon
    B.5.3 Address:
    B.5.3.1Street Address31 route de la Galaise
    B.5.3.2Town/ cityPlan-les-Ouates
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041228848803
    B.5.5Fax number0041228848885
    B.5.6E-mailpatricia.caillon@bracco.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MultiHance
    D.2.1.1.2Name of the Marketing Authorisation holderBracco S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Solution for injection
    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 INNgadobenate dimeglumine
    D.3.9.3Other descriptive nameGADOBENATE DIMEGLUMINE
    D.3.9.4EV Substance CodeSUB20638
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number529
    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 RoleComparator
    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 Dotarem
    D.2.1.1.2Name of the Marketing Authorisation holderGuerbet
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Solution for injection
    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 INNGADOTERIC ACID
    D.3.9.1CAS number 72573-82-1
    D.3.9.4EV Substance CodeSUB07865MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number279.32
    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 Yes
    D.3.11.13.1Other medicinal product typecontrast agent
    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
    Patients have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
    • clinical/neurological symptomatology;
    • diagnostic testing, such as CT or previous MRI examinations; or
    • have had recent brain surgery and are to be evaluated for recurrence
    Pacient má potvrzené nebo vysoce suspektní nádorové onemocnění mozku (primární nebo sekundární), které bylo stanoveno na základě:
    • klinické/neurologické symptomatologie
    • diagnostického vyšetření, jako je CT nebo předchozího vyšetření MR, případně
    • operace mozku v nedávné době a nyní je pacient vyšetřován pro recidivu
    E.1.1.1Medical condition in easily understood language
    Subjects with suspected or known brain tumors.
    Pacienti s podezřením nebo diagnostikovaným nádorem mozku.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10029820
    E.1.2Term Nuclear magnetic resonance imaging gadolinium-enhanced
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives for this study are:

    1) To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of DOTAREM, in terms of the by-subject global diagnostic preference between exams (i.e., based on pre-dose plus post-dose image sets).

    2) To show superiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of DOTAREM, in terms of the by-subject global diagnostic preference between exams (i.e., based on pre-dose plus post-dose image sets).
    Primární cíle tohoto klinického hodnocení jsou:

    1) Prokázat superioritu dávky 0,1 mmol/kg přípravku MULTIHANCE v porovnání s dávkou 0,1 mmol/kg přípravku DOTAREM z hlediska celkové diagnostické preference u pacientů mezi jednotlivými vyšetřeními (tj. na základě souborů snímků před podanou dávkou a po podané dávce léku)

    2) Prokázat superioritu dávky 0,05 mmol/kg přípravku MULTIHANCE v porovnání s dávkou 0,1 mmol/kg přípravku DOTAREM z hlediska celkové diagnostické preference u pacientů mezi jednotlivými vyšetřeními (tj. na základě souborů snímků před podanou dávkou a po podané dávce léku)
    E.2.2Secondary objectives of the trial
    The secondary objectives for this study are:

    1) To compare the two different investigational products in a dose of 0.1 mmol/kg and 0.05 mmol/kg MULTIHANCE and 0.1 mmol/kg DOTAREM, in terms of by-subject global diagnostic preference between exams in the following secondary endpoints:
    • Border delineation of lesions
    • Contrast enhancement of lesions
    • Lesion Internal Morphology
    • Extent of Disease

    2) To compare the two different investigational products in a dose of 0.1 mmol/kg and 0.05 mmol/kg MULTIHANCE and 0.1 mmol/kg DOTAREM, in terms of changes from pre-dose to post-dose for the following quantitative parameters (signal intensity characteristics):
    • Lesion-to-background (brain) ratio (LBR) by lesion
    • Contrast-to-noise ratio (CNR) by lesion
    • Lesion signal intensity enhancement
    Sekundární cíle tohoto klinického hodnocení jsou:

    1) Porovnat dva různé hodnocené přípravky - MULTIHANCE v dávce 0,1 mmol/kg a 0,05 mmol/kg a DOTAREM v dávce 0,1 mmol/kg z hlediska celkové diagnostické preference u pacientů mezi jednotlivými vyšetřeními u těchto sekundárních výsledných parametrů:
    • vymezení hranic lézí
    • zvýraznění kontrastu lézí
    • vnitřní morfologie lézí
    • rozsah nemoci

    2) Porovnat dva různé hodnocené přípravky - MULTIHANCE v dávce 0,1 mmol/kg a 0,05 mmol/kg a DOTAREM v dávce 0,1 mmol/kg z hlediska změn před podanou dávkou a po podané dávce u těchto kvantitativních parametrů (charakteristické vlastnosti intenzity signálu):
    • poměr léze-pozadí (mozku) (Lesion-to-background, LBR) podle lézí
    • poměr kontrast-hluk (Contrast-to-noise ratio, CNR) podle lézí
    • zvýraznění intenzity signálu léze
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Enroll subjects in this study if they meet the following inclusion criteria:

    • Are at least 18 years of age or older

    • Are able to give written informed consent and are willing to comply with the protocol requirements

    • Are scheduled to undergo MRI

    • Are willing to undergo two MRI procedures within 14 days

    • Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
    a) clinical/neurological symptomatology;
    b) diagnostic testing, such as CT or previous MRI examinations; or
    c) have had recent brain surgery and are to be evaluated for recurrence
    Do klinického hodnocení budou zařazeni pacienti, kteří splňují tyto kritéria:

    • Věk 18 let nebo starší

    • Pacient je schopen podepsat informovaný souhlas a je ochotný podrobit se požadavkům protokolu klinického hodnocení

    • Pacient má plánované vyšetření MR

    • Pacient je ochotný podstoupit dvě vyšetření MR v období 14 dní

    • Pacient má potvrzené nebo vysoce suspektní nádorové onemocnění mozku (primární nebo sekundární), které bylo stanoveno na základě:
    a) klinické/neurologické symptomatologie
    b) diagnostického vyšetření, jako je CT nebo předchozího vyšetření MR, případně
    c) operace mozku v nedávné době a nyní je pacient vyšetřován pro recidivu
    E.4Principal exclusion criteria
    Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed:

    • Are pregnant or lactating females. Exclude the possibility of pregnancy:
    a) by testing on site at the institution (serum or urine HCG) within 24 hours prior to the start of each investigational product administration; or
    b) by history (i.e., tubal ligation or hysterectomy); or
    c) post menopausal with a minimum of 1 year without menses

    • Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals

    • Have congestive heart failure (class IV according to the classification of the New York Heart Association)

    • Have suffered a stroke within a year

    • Have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2

    • Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product

    • Have moderate-to-severe renal impairment, defined as a GFR/eGFR ≤ 45 mL/min.

    • Have been previously entered into this study

    • Have received or are scheduled for one of the following:
    a) surgical or chemotherapeutic treatment within three weeks prior to the first examination or between the two examinations
    b) initiation of steroid therapy between the two examinations
    c) radiosurgery between the two examinations

    • Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field

    • Are suffering from severe claustrophobia

    • Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
    Do klinického hodnocení nebudou zařazeni pacienti, kteří nesplňují kritéria pro zařazení, nebo se u nich vyskytuje některý z následujících stavů:

    • Těhotné nebo kojící ženy. Možnost těhotenství je nutno vyloučit:
    a) testem v centru klinického hodnocení (βHCG v séru nebo moči) v období 24 hodin před zahájením podání každého hodnoceného přípravku, nebo
    b) anamnesticky (např. podvaz vejcovodů nebo hysterektomie), nebo
    c) zjištěním, že žena je postmenopauzální, přičemž poslední menstruace byla nejméně před rokem

    • Známá alergie na jednu nebo více složek hodnocených přípravků, nebo anamnéza přecitlivělosti na kovy

    • Městnavé srdeční selhání (IV. třída podle klasifikace NYHA – New York Heart Association)

    • Prodělaná cévní mozková příhoda v posledním roce

    • Pacient dostal nebo se plánuje podání jakékoliv kontrastní látky v období 24 hodin před až 24 hodin po prvním vyšetření nebo v období 24 hodin před až 24 hodin po druhém vyšetření

    • Pacient dostal nebo se plánuje podání hodnocené látky a/anebo zdravotnického prostředku v období 30 dní před zařazením do tohoto klinického hodnocení až do 24 hodin po podání druhého hodnoceného přípravku

    • Středně těžké až těžké postižení ledvin definované jako GFR/eGFR ≤45 ml/min.

    • Pacient byl již v minulosti zařazen do tohoto klinického hodnocení

    • Pacient se podrobil, nebo se u něho plánuje jedna z těchto procedur:
    a) chirurgická léčba nebo chemoterapie v období 3 týdnů před prvním vyšetřením nebo mezi vyšetřeními
    b) zahájení léčby kortikosteroidy mezi dvěma vyšetřeními
    c) radiochirurgický výkon mezi dvěma vyšetřeními

    • Kontraindikace k vyšetření MR, jako je např. kardiostimulátor, magnetický materiál (např. chirurgické svorky), případně jakýkoliv jiný stav, který vylučuje blízkost silného magnetického pole

    • Těžká klaustrofobie

    • Zdravotní stav nebo jiné okolnosti, které by významně snížily možnost získat spolehlivá data, dosáhnout cílů klinického hodnocení, nebo dokončit klinické hodnocení, případně následná vyšetření po podání hodnoceného přípravku
    E.5 End points
    E.5.1Primary end point(s)
    Global diagnostic preference of MultiHance compared to Dotarem.
    Celková diagnostická preference přípravku MultiHance oproti přípravku Dotarem.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Exam 1 (Day 1) and exam 2 (between Day 3 and Day 15).
    První vyšetření (1. den) a druhé vyšetření (mezi 3. a 15. dnem).
    E.5.2Secondary end point(s)
    Analysis of Lesion Visualization
    • Lesion border delineation
    • Lesion contrast enhancement
    • Lesion Internal Morphology
    • Extent of Disease

    Analysis of the Signal Intensity Characteristics
    • Lesion-to-background (brain) ratio (LBR) by lesion
    • Contrast-to-noise ratio (CNR) by lesion
    • Lesion signal intensity enhancement


    Analýza vizualizace lézí
    • vymezení hranic lézí
    • zvýraznění kontrastu lézí
    • vnitřní morfologie lézí
    • rozsah nemoci

    Analýza charakteristckých znak§ intenzity signálu
    • poměr léze-pozadí (mozku) (Lesion-to-background, LBR) podle lézí
    • poměr kontrast-hluk (Contrast-to-noise ratio, CNR) podle lézí
    • zvýraznění intenzity signálu léze
    E.5.2.1Timepoint(s) of evaluation of this end point
    Exam 1 (Day 1) and exam 2 (between Day 3 and Day 15).
    První vyšetření (1. den) a druhé vyšetření (mezi 3. a 15. dnem).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Czech Republic
    Germany
    United States
    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
    The end of the study is defined as the last subject’s image review conducted by the off-site blinded assessor.
    Konec klinického hodnocení je definován jako vyhodnocení snímků posledního pacienta zsalepeným hodnotitelem mimo centrum klinického hodnocení.
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2013-12-20. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects unable to read and/or to sign consent personally. Consent to be attested by an impartial witness having attended the consent process.
    Pacienti, kteří nejsou schopni přečíst nebo podepsat osobně informovaný souhlas. Informovaný souhlas musí být v tomto případě podepsaný nestranným svědkem, který byl přítomen při debatě o informaci pro pacienta a při podpisu informovaného souhlasu.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 176
    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.
    Žádné
    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 Decision2014-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
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