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    Summary
    EudraCT Number:2013-000239-28
    Sponsor's Protocol Code Number:D1693C00001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000239-28
    A.3Full title of the trial
    DECLARE Dapagliflozin Effect on CardiovascuLAR Events
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes
    Studio multicentrico, randomizzato, in doppio cieco, controllato vs placebo per valutare gli effetti di dapaglifozin 10 mg una volta al giorno sull’incidenza della morte per cause cardiovascolari, infarto del miocardio o ictus ischemico in pazienti con diabete di tipo 2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Trial to Evaluate the Effect of Dapaglliflozin on the Incidence of Cardiovascular Events (DECLARE)
    Studio Multicentrico per valutare l'effeto di dapaglifozin sull'incidenza degli eventi cardiovascolari (DECLARE)
    A.3.2Name or abbreviated title of the trial where available
    DECLARE
    DECLARE
    A.4.1Sponsor's protocol code numberD1693C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01730534
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/207/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number001800236993
    B.5.6E-mailinformation.center@astrazeneca.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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameDapagliflozin
    D.3.2Product code BMS-512148
    D.3.4Pharmaceutical form Film-coated 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 INNdapaglifozin
    D.3.9.1CAS number 960404-48-2
    D.3.9.2Current sponsor codeBMS-512148-05
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB90205
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type II Diabetes mellitus
    Diabete mellito di tipo II
    E.1.1.1Medical condition in easily understood language
    Diabetes Type II
    Diabete di tipo II
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    E.1.2System Organ Class 100000004861
    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 efficacy objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy will result in a reduction in the incidence of the composite endpoint of cardiovascular death, myocardial infarction (MI), or ischemic stroke in patients with type 2 diabetes mellitus (T2DM) with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM.
    L'obiettivo primario di efficacia è determinare se il trattamento con dapagliflozin rispetto a placebo quando aggiunto alla terapia corrente comporta una riduzione dell’incidenza dell'endpoint composito di morte cardiovascolare, infarto del miocardio (MI), o ictus ischemico nei pazienti con diabete di tipo 2 e con una malattia cardiovascolare nota o con almeno due fattori di rischio cardiovascolare in aggiunta al diabete mellito di tipo 2.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy in patients with T2DM with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM will result in a reduction of:
    · Hospitalization for Congestive Heart Failure
    ·The composite endpoint of cardiovascular death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization.
    · All-cause mortality
    · Body weight from baseline
    L'obiettivo secondario di efficacia è di determinare se il trattamento con dapaglifozin confrontato con placebo in aggiunta alla terapia standard in pazienti con diabete mellito di tipo 2 con una malattia cardiovascolare nota o con almeno due fattori di rischio cardiovascolare oltre al diabete porterà a una riduzione:
    •dei ricoveri per insufficienza cardiaca congestizia
    •dell’endpoint composito di morte cardiovascolare, infarto del miocardio, ictus ischemico, ospedalizzazione per insufficienza cardiaca, ospedalizzazione per angina pectoris instabile o ospedalizzazione per rivascolarizzazione
    •della mortalità per qualsiasi causa
    •del peso corporeo rispetto al baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients should fulfill the following criteria:
    1. Provision of informed consent prior to any study specific procedures (including run-in)
    2. Female or male aged ≥ 40 years
    3. Diagnosed with T2DM (See Appendix E for details)
    4. High Risk for CV event defined as having either established CV disease and/or multiple risk factors:
    - Established CV Disease (See Appendix E for details)
    OR
    No known cardiovascular disease AND at least two cardiovascular risk factors in addition to T2DM, defined as:
    - Age > 55 years in men and > 60 in women
    AND presence of at least 1 of the following additional risk factors (see Appendix E for details)
    - Dyslipidemia
    - Hypertension
    - Tobacco use

    5. WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
    - WOCBP must have a negative urine pregnancy test. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
    - WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
    For inclusion in the optional genetic research, patients must fulfill the criterion specified in Appendix H.
    Per l'inclusione nello studio i pazienti devono soddisfare i seguenti criteri:
    1.Firma del consenso informato prima di qualsiasi procedura studio-specifica (compreso il run-in)
    2.Maschi o femmine di età ≥ 40 anni
    3.Diagnosi di diabete mellito di tipo 2
    4.Alto rischio per eventi cardiovascolari definito come una malattia cardiovascolare ben definita e/o multipli fattori di rischio:
    - malattia cardiovascolare ben definita o
    nessuna malattia cardiovascolare nota E almeno due fattori di rischio oltre al diabete mellito definiti come:
    -età >55 anni per gli uomini e >60 anni per le donne
    E
    La presenza di almeno uno dei seguenti fattori di rischio aggiuntivi:
    -Dislipidemia
    -Ipertensione
    -Uso di tabacco
    5. Le donne in età fertile devono impegnarsi ad evitare gravidanze durante lo studio e per 4 settimane dopo l’assunzione dell’ultima dose
    -Le donne in età fertile devono avere un test di gravidanza effettuato sulle urine
    Negativo. Per donna in età fertile si intende qualsiasi donna che abbia il ciclo
    mestruale e che non sia stata sottoposta a sterilizzazione chirurgica (isterectomia,legame delle tube o ooforectomia bilaterale) o che non è in postmenopausa.
    - Le donne in età fertile devono essere disposte ad utilizzare un metodo di
    contraccezione che sia giudicato efficace dallo Sperimentatore.

    Per l'inclusione nella parte di ricerca genetica dello studio i pazienti devono soddisfare i criteri indicati nell'Appendice H
    E.4Principal exclusion criteria
    1. Use of the following excluded medications:
    - Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for 2 years or more at any time
    - Current or recent (within 12 months) treatment with rosiglitazone
    - Previous treatment with any SGLT2 inhibitor
    - Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid at a dose equivalent to oral prednisolone ≥10 mg (e.g., betamethasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) per day
    2. Acute cardiovascular event[e.g., acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, any revascularization, decompensated HF, sustained tachycardia <8 weeks prior to randomization. Patients with acute cardiovascular events can be enrolled in the run-in period as long as randomization does not occur within 8 weeks of the event.
    3. Systolic BP >180 or diastolic BP >100 mmHg at randomization
    4. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
    5. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
    6. History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
    7. Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
    8. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including but not limited to cardiovascular (NYHA class IV CHF, recurrent ventricular arrhythmias) or non-cardiovascular disease (e.g., active malignancy with the exception of basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease) and/or a likely fatal outcome within 5 years
    9. Pregnant or breast-feeding patients
    10. Involvement in the planning and/or conduct of the study or other dapagliflozin studies (applies to AZ, BMS, Hadassah and Thrombolysis in Myocardial Infarction [TIMI] or representative staff and/or staff at the study site)
    11. Previous randomization in the present study
    12. Active participation in another clinical study with IP and/or investigational device
    13. Individuals at risk for poor protocol or medication compliance during run-in period (reasonable compliance defined as 80 – 120%, unless a reason for non-compliance is judged acceptable by the Investigator). If for any reason, the Investigator believes that the patient will not tolerate or be compliant with IP or study procedures, the patient should not be randomized and considered a run-in failure.
    Patients will be excluded during run-in and should not be randomized if the following are observed from laboratory or observation during enrollment and run-in assessments:
    14. HbA1c ≥12% or HbA1c<6.5%
    15. AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
    16. CrCl < 60 ml/min (based on the Cockroft-Gault equation)
    17. Hematuria (confirmed by microscopy at Visit 1) with no explanation as judged by the Investigator up to randomization. If bladder cancer is identified, patients are not eligible to participate.
    18. Any reason the Investigator believes the patient is not likely to be compliant with the study medication and protocol.
    Exclusion criteria for the optional genetic research
    The exclusion criteria for the optional genetic research are provided in Appendix H.
    1.Trattamento con uno dei seguenti farmaci:

    •Attuale o recente (entro 24 mesi) trattamento con pioglitazione e/o uso di pioglitazione per 2 anni o più in qualsiasi momento della vita

    •Attuale o recente (entro 12 mesi) trattamento con rosiglitazone

    •Precedente trattamento con inibitori di trasportatori sodio/glucosio SGLT2

    •Pazienti attualmente in trattamento cronico (>30 giorni consecutivi) con uno steroide orale ad un dosaggio equivalente al prednisolone orale ≥10 mg al giorno (cioè betametasone ≥1.2 mg, dexametasone ≥1.5 mg, idrocortisone ≥40 mg)
    2.Evento cardiovascolare acuto (sindrome coronarica acuta (ACS), attacco ischemico transitorio (TIA), ictus, qualsiasi rivascolarizzazione, insufficienza cardiaca scompensata, tachicardia sostenuta nelle 8 settimane prima della randomizzazione). I pazienti con eventi cardiovascolari acuti possono essere arruolati nel periodo di run-in a patto che la randomizzazione avvenga dopo 8 settimane dall’evento.

    3.Pressione sanguigna sistolica >180 e diastolica >100 mmHg alla randomizzazione.

    4.Diagnosi di diabete mellito di tipo 1, diabete giovanile ad insorgenza adulta (MODY) o diabete mellito secondario.

    5.Storia di tumore della vescica o storia di trattamento con radiazioni nel basso addome o pelvi in qualsiasi momento della vita.

    6.Storia di qualsiasi altro tumore maligno nei 5 anni prima dello studio (ad eccetto dei tumori della pelle non melanomi trattati con successo).

    7.Cistite cronica e/o infezioni ricorrenti del tratto urinario ( 3 o più nell’ultimo anno)

    8.Qualsiasi condizione che a giudizio dello sperimentatore possa rendere il paziente impossibilitato a completare lo studio includendo ma non limitatamente a malattie cardiovascolari (NYHA classe IV CHF, aritmia ventricolare ricorrente) o non cardiovascolari (tumori maligni in atto ad accezione dei tumori del carcinoma basale, cirrosi, malattia polmonare cronica, severe malattie autoimmuni) e/o con outcome fatale entro i 5 anni

    9.Pazienti in gravidanza o allattamento.

    10.Coinvolgimento della progettazione e/o conduzione dello studio o di altri studi con dapaglifozin (si applica ad AZ, BMS, Hadassah e gruppo TIMI o staff rappresentativi e/o staff del centro sperimentale.)

    11.Precedente randomizzazione nello studio

    12.Attiva partecipazione in un altro studio clinico con un prodotto sperimentale e/o un dispositivo medico.

    13.Individui a rischio di poca complianza al protocollo o al farmaco nel periodo di run-in (complianza ragionevole definita come 80-120%, a meno che una motivazione della non complianza sia accettata dallo Sperimentatore). Se per qualsiasi ragione lo Sperimentatore pensa che il paziente non tollererà o non sarà compliante al farmaco ed alle procedure di studio il paziente non dovrebbe essere arruolato nello studio e dovrebbe essere considerato un “run-in failure”.

    I pazienti saranno esclusi durante il periodo di run-in e non dovrebbero essere randomizzati se si dovessero riscontrare i seguenti valori di laboratorio all’arruolamento o durante il periodo di run-in:

    14. HbA1c ≥12% o HbA1c<6.5%

    15. AST or ALT >3x ULN o Bilirubina Totale >2.5 x ULN

    16. CrCl < 60 ml/min (basato sull’equazione di Cockroft-Gault)

    17.Ematuria (confermata da microscopia a visita 1) senza apparente motivo a giudizio dello Sperimentatore prima della randomizzazione. Se viene identificato tumore della vescica il paziente non può partecipare.

    18.Qualsiasi motivo per cui lo Sperimentatore ritenga che il paziente non sarebbe compliante all’assunzione del farmaco in studio e alle procedure del protocollo.

    Criteri di esclusione per la ricerca genetica opzionale:
    I criteri di esclusione per la ricerca genetica opzionale sono specificati nell'Appendice H
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome efficacy variable of the study is the composite endpoint of cardiovascular death, myocardial infarction, or ischemic stroke (time to first event). These events will be adjudicated.
    La principale variabile di efficacia esito dello studio è l'endpoint composito di morte cardiovascolare morte, infarto miocardico, o ictus ischemico (tempo al primo evento). Questi eventi saranno aggiudicati.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is event triggered and will be evaluated at 1/3 of primary events, 2/3 of primary events and when we have 100% of the primary events, which means at 463, 927 and 1390 primary events
    Questo evento sarà raggiunto quando saranno valutati 1/3 degli eventi primari, 2/3 degli eventi primari e quando si sarà raggiunto il 100% degli eventi primari, che significa a 463, 927 e 1390 eventi primari
    E.5.2Secondary end point(s)
    The secondary objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy in patients with T2DM with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM will result in a reduction of:
    · Hospitalization for Congestive Heart Failure
    · The composite endpoint of cardiovascular death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization.
    · All-cause mortality
    · Body weight from baseline
    L'obiettivo secondario di efficacia è di determinare se il trattamento con dapaglifozin confrontato con placebo in aggiunta alla terapia standard in pazienti con diabete mellito di tipo 2 con una malattia cardiovascolare nota o con almeno due fattori di rischio cardiovascolare oltre al diabete porterà a una riduzione:
    -ricovero per insufficienza cardiaca congestizia
    -l'endpoint composito di morte cardiovascolare, infarto miocardico, ictus ischemico, ricovero per insufficienza cardiaca, ricovero per angina pectoris instabile o ricovero per rivascolarizzazione
    -mortalità per qualsiasi causa
    -variazione del peso corporeo dal baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will only be evaluated once – and that is when the study stops. It could be when we have 1/3 of primary events OR when we have 2/3 of primary events OR when we have all primary events.
    Gli endpoints secondari saranno valutati una sola volta- e cioè a fine studio. Ciò potrebbe avvenire quando si raggiunge 1/3 degli eventi primari o quando si raggiunge 2/3 degli eventi primari o quando si raggiungono tutti.
    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 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 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 Yes
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA265
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    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 end of the study is defined as ‘the last visit of the last patient undergoing the study’.
    La fine dello studio è definita come "LSLV".
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 8575
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8575
    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 state340
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5440
    F.4.2.2In the whole clinical trial 17150
    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)
    Background medication and post-study treatment will not be provided by the Sponsor.
    I farmaci di background e i trattamenti da assumere dopo la fine dello studio non saranno forniti dallo Sponsor
    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 Decision2013-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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