Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-003313-34
    Sponsor's Protocol Code Number:SPD489-345
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-02-06
    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 number2012-003313-34
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults with Binge Eating Disorder
    Studio di estensione di 12 mesi in aperto, di fase III, multicentrico, per valutare la sicurezza e la tollerabilità di SPD489 nel trattamento di pazienti adulti affetti da disturbo da alimentazione incontrollata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the study drug, SPD489, in adults subjects who are suffering from Binge Eating Disorder
    Uno studio per valutare il farmaco SPD489, in pazienti adulti affetti da disturbo da alimentazione incontrollata
    A.3.2Name or abbreviated title of the trial where available
    SPD489-345
    SPD489-345
    A.4.1Sponsor's protocol code numberSPD489-345
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01657019
    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 SponsorShire Development LLC
    B.1.3.4CountryUnited States
    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 supportShire Development LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Pharmaceutical Ltd
    B.5.2Functional name of contact pointMedical Communications
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityChineham, Basingstoke
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448000556614
    B.5.5Fax number+441256894714
    B.5.6E-mailmedinfoglobal@shire.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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss behaviors of bulimia nervosa. Though currently listed in the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) appendix as a disorder provided for further study, it has been recommended that BED be formally included as an eating disorder in DSM-V.
    il disturbo da alimentazione incontrollata è caratterizzato da episodi ricorrenti angoscianti di consumo incontrollato di grandi quantità di cibo(abbuffate)senza l’inappropriata compensativa perdita di peso caratteristica della bulimia nervosa.Sebbene attualmente elencata nell’appendice del “Diagnostic and Statistical Manual of Mental Disorders-IV(DSM-IV)”come un disturbo contemplato per ulteriori studi, è stato raccomandato che BED sia formalmente incluso come un disturbo dell’alim.nel DSM-V.
    E.1.1.1Medical condition in easily understood language
    Binge eating disorder
    disturbo da alimentazione incontrollata
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of SPD489 (50 and 70mg/day) for the treatment of BED in adults 18-55 years of age (inclusive at the time of consent for the respective antecedent SPD489 BED trial). Long-term safety will be described using:
    1. Occurrence of TEAEs.
    2. Response to the Columbia Suicide Severity Rating Scale (C-SSRS).
    3. Specific evaluation of blood pressure and pulse, weight and waist circumference, clinical laboratory evaluations, and ECG results.
    valutare la sicurezza e la tollerabilità a lungo termine di SPD489 (50 e 70 mg/die) nel trattamento del BED in pazienti adulti di età compresa tra i 18 e i 55 anni compiuti all’epoca del consenso al precedente studio SPD489 sul BED. La sicurezza a lungo termine verrà descritta come segue:
    1. Comparsa di eventi avversi correlati al trattamento (TEAE).
    2. Risposta alla scala C-SSRS (Columbia-Suicide Severity Rating Scale) sul rischio di suicidio.
    3. Analisi specifiche di pressione sanguigna, frequenza cardiaca, peso e circonferenza della vita, valutazione delle analisi di laboratorio e risultati dell’elettrocardiogramma (ECG).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effect of SPD489 on the following clinical experience outcomes (including efficacy and quality of life [QoL]):
    1. The global impressions of BED improvement as measured by the Clinical Global Impressions of Improvement (CGI-I) scale.
    2. The response in binge eating behavior as measured by Eating Disorder Questionnaire (EDE-Q).
    3. QoL as measured by the EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L).
    Exploratory Objectives:
    1. To explore the utilization of healthcare resources in subjects with moderate to severe BED using the Patient Resource Utilization Questionnaire for Binge Eating Disorder (PRUQ BED).
    2. To explore the role of additional parameters of interest in the treatment of BED. Potential parameters that may be studied include, but are not limited to, C-reactive protein (CRP), leptin, and ghrelin.
    gli obiettivi secondari comprendono la valutazione degli effetti di SPD489 sui seguenti risultati dell’esperienza clinica (inclusa l’efficacia e la qualità della vita [QoL]).
    1.Impressione globale relativa al miglioramento del BED misurata per mezzo della scala dell’impressione clinica globale di miglioramento (CGI-I).2.Risposta a comportamenti di alimentazione incontrollata sulla base del questionario per la valutazione dei disturbi alimentari (EDE-Q).3. Qualità della vita misurata mediante il questionario di autovalutazione EQ-5D-5L (Gruppo EuroQoL,vers.a 5 dimensioni e 5 livelli).Obiettivi esplorativi 1.Utilizzo delle risorse dell’assistenza sanitaria in soggetti affetti da BED da moderato a grave mediante il questionario PRUQ-BED (Patient Resource Utilization Questionnaire for BED).2.Ruolo di eventuali ulteriori parametri di interesse nel trattamento del BED. Potenziali parametri di studio includono, a titolo esempl.,la proteina C-reattiva,la leptina e la grelina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject cannot be enrolled in the study before all inclusion criteria (including test results) are confirmed.

    All subjects must meet the following criteria:

    • Subject has completed 1 of the respective antecedent SPD489 BED trials.
    • Subject is between 18-55 years of age (or age of majority if greater than 18 years of age, as defined by local regulations), inclusive, at the time of consent from the antecedent trial.
    • Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
    • Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by physical examination findings, clinical laboratory test results, ECG results, or vital sign results that would preclude treatment with SPD489.
    • Subject has an understanding, ability, and willingness to fully comply with study related procedures and restrictions.
    • Soggetti che hanno completato uno dei rispettivi studi SPD489 precedenti sul BED.
    • Soggetti di età compresa tra i 18 e i 55 anni compiuti (o in ogni caso soggetti che hanno raggiunto la maggior età, se superiore ai 18 anni, come prescritto dalle normative locali) al momento del consenso allo studio precedente.
    • Soggetti in grado di fornire un consenso informato scritto, firmato e datato, alla partecipazione allo studio prima di effettuare qualsiasi procedura prevista dallo studio.
    • Soggetti la cui valutazione medica è risultata soddisfacente e per i quali né l’esame obiettivo, né i risultati delle analisi cliniche di laboratorio, dell’elettrocardiogramma e dei segni vitali hanno evidenziato alcuna anomalia clinica significativa o rilevante che potrebbe precludere il trattamento con SPD489.
    • Soggetti disposti a e in grado di comprendere e seguire pienamente le procedure e le restrizioni associate allo studio.
    E.4Principal exclusion criteria
    Subjects that have a gap in participation of 30 days or more from completion of the antecedent study Follow-up Visit are excluded from the study if any of the following criteria are met:

    • Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa, confirmed by SCID-I Module H.
    • Subject has a current comorbid Axis I or Axis II psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms (note: subjects with mild mood or anxiety symptoms that do not meet criteria for Axis I disorder, do not require treatment based on the Investigator’s assessment, and do not confound efficacy or safety assessments in the opinion of the examining Investigator may be included).

    Subjects are excluded from the study if any of the following exclusion criteria are met:

    • Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
    • Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
    • Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder in accordance with Diagnostic Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. Nicotine dependence is not exclusionary.
    • Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
    • Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
    • Subjects with a history of moderate to severe hypertension or an average (of 3 readings) resting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at study entry. Note: subjects with mild (Stage 1), well-controlled hypertension on a stable antihypertensive treatment regimen, defined as having maintained the current dose for a period of at least 3 months or more at the time of the Screening Visit (Visit -1) are allowed.
    • Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious disease process requiring antibiotics or diabetes), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Subject will be excluded if he or she has any additional condition(s) that in the Investigator’s opinion would prohibit the subject from completing the study or would not be in the best interest of the subject to participate in the study. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
    I soggetti per i quali sono trascorsi ≥30 dal completamento della precedente visita di follow-up verranno esclusi dallo studio nei seguenti casi:
    • Soggetti con sintomi concomitanti di bulimia nervosa o anoressia nervosa come confermato dal modulo H dell’SCID-I.
    • Soggetti affetti da comorbidità quali disturbi psichiatrici di asse I o II, controllati mediante l’uso di farmaci vietati nell'ambito del presente studio o non controllati ed associati a sintomi significativi. Nota: potranno essere inclusi nello studio soggetti caratterizzati da lievi sintomi dell’umore o di ansietà insufficienti per una diagnosi del disturbo di asse I e che, secondo lo sperimentatore, non necessitano trattamento, né comportano alcun rischio di inficiare le valutazioni di efficacia o sicurezza.
    I soggetti che soddisfino uno qualsiasi dei seguenti criteri di esclusione non potranno prender parte allo studio:
    • Soggetti con precedenti di lunga data di psicosi, mania, ipomania, demenza o ADHD.
    • Soggetti considerati a rischio di suicidio secondo lo sperimentatore, o soggetti che hanno tentato il suicidio o manifestano al momento ideazioni suicidarie attive. Soggetti con ideazioni suicidarie passive e intermittenti non vanno necessariamente esclusi, sempre sulla base della valutazione dello sperimentatore.
    • Soggetti con precedenti recenti (entro gli ultimi sei mesi) di sospetto abuso di stupefacenti o disturbi da dipendenza in accordo con i criteri del DSM-IV-TR. Soggetti con precedenti di lunga data di uso di amfetamine e cocaina, o di abuso e/o di dipendenza da altri stimolanti. La dipendenza da nicotina non è motivo di esclusione.
    • Soggetti con precedenti noti di malattia cardiovascolare sintomatica, arteriosclerosi avanzata, anomalia cardiaca strutturale, cardiomiopatia, gravi anomalie del ritmo cardiaco, coronaropatia, o altre patologie cardiache gravi che potrebbero aumentarne la vulnerabilità agli effetti simpatico-mimetici degli stimolanti.
    • Soggetti con precedenti familiari noti di morte cardiaca improvvisa o di aritmia ventricolare.
    • Soggetti con precedenti di ipertensione moderata o grave o soggetti la cui pressione sistolica media a riposo (su tre letture) è >139 mmHg o la cui pressione diastolica media (su tre letture) è >89 mmHg all’ingresso nello studio (visita 0). Nota: potranno essere inclusi allo studio i soggetti con ipertensione lieve e controllata (stadio 1), che seguono una terapia con un regime di trattamento antiipertensivo stabile, ovvero la cui dose non ha subito modifiche per almeno tre mesi o più alla visita di screening (visita -1).
    • Soggetti affetti da patologia concomitante cronica o acuta (ad es. grave rinite allergica, processo infettivo che richiede uso di antibiotici, diabete), disabilità o altra patologia che potrebbe inficiare i risultati della valutazione di sicurezza condotta nel corso dello studio o che potrebbe aumentare i rischi per il soggetto. Soggetti affetti da patologie che, secondo lo sperimentatore, potrebbero compromettere il completamento dello studio da parte del soggetto o rendere nulli i benefici dello stesso. Tali affezioni comprendono malattie gravi o patologie cliniche instabili che potrebbero ostacolare il rispetto del protocollo. Potranno invece essere inclusi pazienti affetti da asma lieve e controllata.
    E.5 End points
    E.5.1Primary end point(s)
    • The number and percentage of TEAEs
    • Response to the C-SSRS
    • Specific evaluation of blood pressure and pulse, weight and waist circumference, BMI, clinical laboratory evaluations, and ECG results.
    • Numero e percentuale di TEAE
    • Risposta alla scala C-SSRS
    • Analisi specifiche di pressione sanguigna, frequenza cardiaca, peso e circonferenza della vita, IMC, valutazione delle analisi di laboratorio e risultati dell’elettrocardiogramma (ECG).
    E.5.1.1Timepoint(s) of evaluation of this end point
    • TEAEs, C-SSRS, BP/Pulse, Weight: Visits Scr/0-17
    • Waist Circumference: Visits Scr/0, 4, 8, 12, 16/ET
    • BMI: Visits Scr/0
    • Labs: Scr/0, 6, 9, 16/ET
    • ECG: Scr/0-4, 8, 12, 16/ET-17
    • TEAEs, C-SSRS, BP/Pulse, Weight: Visite Scr/0-17
    • Waist Circumference: Visite Scr/0, 4, 8, 12, 16/Fine Studio
    • BMI: Visite Scr/0
    • Labs: Scr/0, 6, 9, 16/Fine studio
    • ECG: Scr/0-4, 8, 12, 16/Fine studio-17

    E.5.2Secondary end point(s)
    • CGI-I
    • EDE-Q
    • EQ-5D-5L
    • CGI-I
    • EDE-Q
    • EQ-5D-5L
    E.5.2.1Timepoint(s) of evaluation of this end point
    • CGI-I: Visits 1- 16/ET
    • EDE-Q: Visits 5 – 16/ET
    • EQ-5D-5L: Visits 0, 8 and 16/ET
    • CGI-I: Visite 1- 16/Fine studio
    • EDE-Q: Visite 5 – 16/ Fine studio
    • EQ-5D-5L: Visite 0, 8 and 16/ Fine studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy 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 Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto, ottimizzazione della dose seguita dal mantenimento della dose
    Open-label, Dose Optimization followed by Maintenance
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    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 trial is signified by the last patient finishing the last visit (the Follow-up Visit) of the trial.
    La conclusione della sperimentazione è definita come l’ultimo paziente che finisce l’ultima visita (visita di follow-up) della sperimentazione.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days9
    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: 530
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 530
    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
    Nessuno
    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 Decision2013-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA