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    Summary
    EudraCT Number:2013-003191-12
    Sponsor's Protocol Code Number:TUD-2DAUNO-058
    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:2015-06-29
    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 number2013-003191-12
    A.3Full title of the trial
    Randomized comparison between two dose levels of daunorubicin and between one versus two cycles of induction therapy for adult patients with acute myeloid leukemia ≤60 years
    Ramdomizovaná studie srovnávající účinnost a bezpečnost rozdílných dávek daunorubicinu a účinnost a bezpečnost jednoho versus dvou cyklů indukční chemoterapie u dospělých pacientů s akutní myeloidní leukémií pod 60 let věku
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized comparison between two dose levels of daunorubicin and between one versus two cycles of therapy for adult patients with acute myeloid leukemia ≤60 years
    Ramdomizovaná studie srovnávající účinnost a bezpečnost rozdílných dávek daunorubicinu a účinnost a bezpečnost jednoho versus dvou cyklů indukční chemoterapie u dospělých pacientů s akutní myeloidní leukémií pod 60 let věku
    A.3.2Name or abbreviated title of the trial where available
    DAUNODOUBLE
    DAUNODOUBLE
    A.4.1Sponsor's protocol code numberTUD-2DAUNO-058
    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 SponsorTechnische Universität Dresden
    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 supportUCC Dresden
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportUniversitätsklinikum Dresden
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Dresden
    B.5.2Functional name of contact pointMK I Bereich Klinische Studien
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstraße 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number04903514585158
    B.5.5Fax number04903514584367
    B.5.6E-mailfrank.staps@uniklinikum-dresden.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 Daunoblastin
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER PHARMA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/585
    D.3 Description of the IMP
    D.3.1Product nameDaunoblastin
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaunorubicin
    D.3.9.3Other descriptive nameDAUNORUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01556MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Cerubidine
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/585
    D.3 Description of the IMP
    D.3.1Product nameCerubidine
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaunorubicin
    D.3.9.3Other descriptive nameDAUNORUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01556MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Daunoblastina
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/585
    D.3 Description of the IMP
    D.3.1Product nameDaunoblastina
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaunorubicin
    D.3.9.3Other descriptive nameDAUNORUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01556MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain ≥20% blasts of all nucleated cells or differential blood count must contain ≥20% blasts. In acute erythroid leukemia, ≥20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
    Patients at the age of 18 to 60 years.
    Nově diagnostikovaná akutní myeloidní leukémie (AML) jiná než akutní promyelotická leukémie dle WHO kritérií, tj. aspirát nebo biopsie kostní dřeně musí obsahovat ≥20% blastů z celkových buněk majících jádro nebo diferenciální krevní obraz musí obsahovat ≥20% blastů. U aktuní erythroidní leukémie, ≥20% blastů ze všech ne-erythroidních buněk kostní dřeně. U AML definované cytogenetickými aberacemi, míra blastů smí být <20%. Sekundární AML jsou také vhodné k zařazení.
    Pacienti ve věku 18-60 let.
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed AML other than acute promyelocytic leukemia (APL) at the age of 18 - 60 years
    Nově zjištěná akutní myeloidní leukémie (AML) jiná než promyelotická leukémie (APL) ve věku 18-60 let.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10066353
    E.1.2Term Treatment related acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000887
    E.1.2Term Acute myeloid leukemia in remission
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10054294
    E.1.2Term Acute myeloid leukemia (in remission)
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Trial part I: To investigate whether a higher dose of daunorubicin in induction chemotherapy leads to an in-crease in good responders defined as having <5% myeloid blasts on day 15 after start of induction
    - Trial part II: To investigate whether the rate of CR after single induction is similar to the CR rate after double induction in patients with a good response to induction I.
    -Čast I KH: Zjistit, zdali vyšší dávka daunorubicinu v indukční chemoterapii povede k vyššímu počtu na léčbu dobře reagujících pacientů, tj. pacientů s podílem myeloidních blastů <5% v den 15 po začátku indukce I.
    - Část II KH: Zjistit, zdali míra kompletní remise po jedné jediné indukci je podobná míře kompletní remise po dvojité indukci u pacientů s dobrou léčebnou odpovědí na indukci I.
    E.2.2Secondary objectives of the trial
    - To investigate whether a higher dose of daunorubicin in induction chemotherapy will lead to an increase in cytogenetic and molecular complete remissions.
    - To investigate whether a higher dose of daunorubicin will lead to improved event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS).
    - To investigate whether EFS, RFS and OS is similar after single versus double induction in patients with good response to induction I.
    - To investigate a possible correlation between the level of cytogenetic and molecular minimal residual disease after induction treatment with survival outcomes EFS, RFS and OS.
    • Zjistit, zdali vyšší dávka daunorubicinu v indukční chemoterapii povede ke zvýšení pravděpodobnosti dosažení kompletní cytogenetické a molekulární remise.
    • Zjistit, zdali vyšší dávka daunorubicinu povede k vyšší míře přežití bez příhod (EFS, event-free survival), přežití bez relapsu (RFS, relapse-free survival) a celkového přežití (OS, overal survival).
    • Zjistit, zdali EFS, RFS a OS jsou podobné po jedné jediné versus dvojité indukci u pacientů s dobrou léčebnou odpovědí na indukci I.
    • Prověřit možnou korelaci mezi úrovní cytogenetické a molekulární léčebné odpovědi (MRD) po indukční léčbě s přežitím EFS, RFS a OS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain ≥20% blasts of all nucleated cells or differential blood count must contain ≥20% blasts. In acute erythroid leukemia, ≥20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
    - Age 18-60 years
    - ECOG performance status 0-2
    - Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
    o Total bilirubin ≤ 1.5 times the upper limit of normal
    o ALT and AST ≤ 2.5 times upper limit of normal
    o Creatinine ≤ 1.5 times upper limit of normal
    - Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by transthoracal twodimensional echocardiography (“M Mode”) or MUGA scan
    - Signed Informed Consent
    - Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
    o Post-menopausal (12 months of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH > 40 U/ml)
    o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
    o Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
    o Sexual abstinence
    o Vasectomy of the sexual partner
    • Nově diagnostikovaná akutní myeloidní leukémie (AML) jiná než akutní promyelotická leukémie dle WHO kritérií, tj. aspirát nebo biopsie kostní dřeně musí obsahovat ≥20% blastů z celkových buněk majících jádro nebo diferenciální krevní obraz musí obsahovat ≥20% blastů. U aktuní erythroidní leukémie, ≥20% blastů ze všech ne-erythroidních buněk kostní dřeně. U AML definované cytogenetickými aberacemi, míra blastů smí být <20%. Sekundární AML jsou také vhodné k zařazení.
    • Věk 18-60 let
    • ECOG 0-2
    • Přiměřené jaterní a renální funkce, hodnoty z laboratorního vyšetření provedeného do 7 dnů před screeningem musí splňovat tyto limity:
    o Celkový bilirubin ≤ 1.5 x horní limit normálu
    o ALT a AST ≤ 2.5 x horní limit normálu
    o Kreatinin ≤ 1.5 x horní limit normálu
    • Přiměřené srdeční funkce, tj. ejekční frakce levé komory (LVEF) ≥ 50% při zhodnocení transthorakální dvourozměrnou echokardiografií (M Mode”) nebo MUGA sken
    • Podepsaný informovaný souhlas
    • Ženy musí splnit aspoň jedno z následujících kritérií:
    o Po menopauze (12 měsíců přirozeně amenorrhea nebo 6 měsíců amenorrhea při sérovém FSH > 40 U/ml)
    o Po operaci – bilaterální ovariektomii s nebo bez hysterektomie
    o Kontinuální a správné používání/užívání kontracepční metod s Pearl indexem <1% (např. implantáty, depotní formy, orální kontracepce, nitroděložní tělísko)
    o Sexuální abstinence
    o Vazektomie sexuálního partnera
    E.4Principal exclusion criteria
    - Patients who are not eligible for standard chemotherapy as assessed by the treating physician
    - Central nervous system manifestation of AML
    - Cardiac disease: i.e. heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
    - Patients undergoing renal dialysis
    - Chronic pulmonary disease with clinical relevant hypoxia
    - Known HIV or Hepatitis infection
    - Uncontrolled active infection
    - Medical conditions other than AML with an estimated life expectancy below 6 months
    - Previous treatment of AML except hydroxyurea up to 5 days
    - Relapsed or primary refractory AML
    - Acute promyelocytic leukemia
    - Previous anthracyclin-containing chemotherapy
    - Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment
    - Incapability of understanding purpose and possible consequences of the trial
    - Pregnant or breastfeeding women
    - Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)
    • Pacienti, u kterých, dle zhodnocení ošetřujícím lékařem, není vhodná standardní chemoterapie
    • Srdeční onemocnění: např. srdeční selhání NYHA III nebo IV, nestabilní koronární arteriální choroba (MI více než 6 měsíců před studií je povoleno), závažná srdeční komorová arytmie vyžadující antiarytmickou léčbu
    • Projevy AML v centrálním nervovém systému
    • Pacienti podstupující renální dialýzu
    • Chronická plicní nemoc s klinicky závažnou hypoxií
    • Známá nákaza HIV nebo hepatitidou
    • Nekontrolovaná aktivní infekce
    • Zdravotní problémy jiné než AML s odhadovanou délkou života méně než 6 měsíců
    • Předléčení AML kromě hydroxyurey do 5 dní
    • Relaps nebo primární refractory AML
    • Akutní promyelotická leukémie
    • Předchozí léčba chemoterapií obsahující antracyklin
    • Léčba jakoukoli známou neregistrovanou léčivou látkou nebo experimentální léčba během 4 týdnů před náborem
    • Neschopnost porozumět podstatě a možným následkům klinického hodnocení
    • Těhotné nebo kojící ženy
    • Důkaz, že pacient pravděpodobně nebude dodržovat protokol léčby (např. nedostatečná compliance)
    E.5 End points
    E.5.1Primary end point(s)
    - Trial part I: Rate (percentage) of good responders two weeks after start of induction defined by the presence of <5% myeloid blasts on day 15 after start of IT.
    - Trial part II: Rate (percentage) of complete hematological remissions as defined by standard criteria [Döhner 2010] after induction treatment.
    • Část I KH: Míra (procentuální podíl) subjektů dobře reagujících na léčbu 2 týdny po začátku indukce, definovaná jako přítomnost < 5% myeloidních blastů v den 15 po startu indukční terapie
    • Část II KH: Míra (procentuální podíl) kompletních hematologických remisí po indukční léčbě, definovaná dle standardních kritérií [Döhner 2010]
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Trial part I: 15 days after start of induction I
    - Trial part II: day 35 after start of last in-study induction
    -Část I KH: 15. den po začátku indukce I
    -Část II KH: den 35 po začátku poslední indukce ve studii
    E.5.2Secondary end point(s)
    - Efficacy Endpoints:
    o Rate of complete molecular and cytogenetic remissions
    o Event-free survival
    o Relapse-free survival
    o Overall survival
    - Safety Endpoints:
    o Rate of early deaths (2 weeks) and induction deaths (until day 60 or beginning of consolidation treatment – whichever occurs first)
    o Incidence of serious infectious complications (Grades 3-4 CTCAE V4.0)
    o Sonographic cardiac left ventricular ejection fraction
    o Serum levels of pro-BNP and Trop-T
    o Incidence of CTCAE grade ≥3 cardiac complications
    Parametry účinnosti:
    • Míra kompletní molekulární a cytogenetické remise
    • Přežití bez příhod (EFS, event-free survival),
    • Přežití bez relapsu (RFS, relapse-free survival)
    • Celkové přežití (OS, overal survival).
    Parametry bezpečnosti:
    • Míra časných úmrtí (2 týdny) a úmrtí v indukci (před dnem 60 nebo před počátkem consolidation léčby – podle toho, co nastane dříve)
    • Výskyt závažných infekčních komplikací (stupně 3-4 CTCAE V.4.0.)
    • Sonograficky- ejekční frakce levé srdeční komory
    • Sérové hladiny pro-BNP a Trop-T
    • Výskyt srdečních komplikací stupně CTCAE ≥3
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Efficacy Endpoints: day 35 after start of last in-study induction; 2 years
    - Safety Endpoints: regulary; within 2 weeks after start of induction; until day 60 or beginning of consolidation treatment – whichever occurs first
    -Parametry účinnosti: den 35 po začátku poslední indukce ve studii; 2 roky
    -Parametry bezpečnosti: do 2 týdnu po začátku indukce až po den 60 nebo po počátek konsolidační léčby – podle toho, co nastane dříve
    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 Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    stejný léčivý přípravek - standardní dávka
    same medicinal product using standard dose
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    last patient last visit
    poslední vizita posledního pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months55
    E.8.9.1In the Member State concerned days
    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: 230
    F.1.3Elderly (>=65 years) No
    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 state230
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 436
    F.4.2.2In the whole clinical trial 436
    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)
    Patients who drop out will pass a reduced end of study visit (only consists of assessment of ECG, echocardiography and heart enzymes) within one week they go off study. Further treatment will continue outside the clinical trial at the discretion of the treating physician.
    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 Decision2015-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
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