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    Summary
    EudraCT Number:2012-000098-21
    Sponsor's Protocol Code Number:TDE-PH-311
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-11
    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 number2012-000098-21
    A.3Full title of the trial
    An Open Label Extension Study of UT-15C in subjects with Pulmonary
    Arterial Hypertension- A long term follow up to protocol TDE-PH-310
    Studio di estensione in aperto su UT-15C in soggetti con ipertensione arteriosa polmonare - Follow-up a lungo termine del protocollo TDE-PH-310
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open Label Extension Study of UT-15C in subjects with Pulmonary
    Arterial Hypertension
    Studio di estensione in aperto su UT-15C in soggetti con ipertensione arteriosa polmonare
    A.4.1Sponsor's protocol code numberTDE-PH-311
    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 SponsorUNITED THERAPEUTICS
    B.1.3.4CountryUnited Kingdom
    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 supportUnited Therapeutics Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnited Therapeutics Europe Ltd
    B.5.2Functional name of contact pointRegulatory Department
    B.5.3 Address:
    B.5.3.1Street AddressUnither House, Curfew Bell Roadm
    B.5.3.2Town/ cityChertsey, Surrey
    B.5.3.3Post codeKT16 9FG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044 01932 573855
    B.5.5Fax number0044 01932 573856
    B.5.6E-mailinfo1@unither.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 No
    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/3/05/310
    D.3 Description of the IMP
    D.3.1Product nametreprostinil diethanolamine
    D.3.2Product code UT-15C
    D.3.4Pharmaceutical form Prolonged-release capsule
    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.3.9.1CAS number 830354-48-8
    D.3.9.2Current sponsor codeUT-15C SR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.125
    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 No
    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/3/05/310
    D.3 Description of the IMP
    D.3.1Product nametreprostinil diethanolamine
    D.3.2Product code UT-15C
    D.3.4Pharmaceutical form Prolonged-release capsule
    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.3.9.1CAS number 830354-48-8
    D.3.9.2Current sponsor codeUT-15C SR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.25
    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 No
    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/3/05/310
    D.3 Description of the IMP
    D.3.1Product nametreprostinil diethanolamine
    D.3.2Product code UT-15C
    D.3.4Pharmaceutical form Prolonged-release capsule
    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.3.9.1CAS number 830354-48-8
    D.3.9.2Current sponsor codeUT-15C SR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.5
    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: 4
    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 No
    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/3/05/310
    D.3 Description of the IMP
    D.3.1Product nametreprostinil diethanolamine
    D.3.2Product code UT-15C
    D.3.4Pharmaceutical form Prolonged-release capsule
    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.3.9.1CAS number 830354-48-8
    D.3.9.2Current sponsor codeUT-15C SR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 5
    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 No
    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/3/05/310
    D.3 Description of the IMP
    D.3.1Product nametreprostinil diethanolamine
    D.3.2Product code UT-15C
    D.3.4Pharmaceutical form Prolonged-release capsule
    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.3.9.1CAS number 830354-48-8
    D.3.9.2Current sponsor codeUT-15C SR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Pulmonary Arterial Hypertension
    Ipertensione arteriosa polmonare
    E.1.1.1Medical condition in easily understood language
    Pulmonary Arterial Hypertension
    Ipertensione arteriosa polmonare
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to provide UT-15C for eligible subjects who participated in TDE-PH-310
    Fornire UT-15C ai soggetti idonei che hanno partecipato allo studio TDE-PH-310
    E.2.2Secondary objectives of the trial
    1) To assess the long-term safety of UT-15C 2) To assess the effect of continued long-term therapy with UT-15C on exercise capacity (6MWT/Borg dyspnea score), WHO functional class, and plasma concentrations of NT-proBNP (Week 48 only)
    1) Verificare la sicurezza a lungo termine di UT-15C orale 2) Verificare l’effetto di una terapia a lungo termine continua con UT-15C sulla capacità di esercizio (distanza percorsa a piedi in sei minuti [six minute walk distance, 6MWD]/punteggio della dispnea su Borg), classe funzionale dell’Organizzazione mondiale della sanità (OMS), e frammento N-terminale del pro-peptide natriuretico cerebrale (N-terminal pro-brain natriuretic peptide, NT-proBNP) (solo alla Settimana 48)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.The subject voluntarily provides informed consent to participate in the study. 2.The subject participated in study TDE-PH-310 and met the definition of clinical worsening (as specified in protocol TDE PH 310), remained on study drug, was compliant with study procedures and assessments during the TDE-PH-310 study or was currently enrolled in that study at the time the study was discontinued by the Sponsor. 3.Women of childbearing potential (WOCBP) must practice true abstinence from intercourse or use two different forms of highly effective contraception for the duration of the study, and for at least 30 days after discontinuing study medication. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptives (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device (IUD), or (4) partner vasectomy. For women of childbearing potential, a negative urine pregnancy test is required at Baseline (study entry) prior to initiating study medication. WOCBP includes 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 [defined as amenorrhea for at least 12 consecutive months]. 4.Males participating in the study must use a condom during the length of the study, and for at least 48 hours after their last dose of study medication.
    1. Il soggetto fornisce volontariamente il consenso informato a partecipare allo studio.
    2. Il soggetto ha partecipato allo studio TDE-PH-310 e ha soddisfatto la definizione di peggioramento clinico (secondo quanto specificato nel protocollo TDE PH 310), ha proseguito l’assunzione del farmaco in studio, si è attenuto alle procedure e alle valutazioni dello studio durante lo studio TDE-PH-310 oppure è stato arruolato attualmente in tale studio nel momento in cui lo studio è stato interrotto dallo Sponsor.
    3. Le donne potenzialmente fertili (women of childbearing potential, WOCBP) devono astenersi completamente dai rapporti sessuali oppure utilizzare due diverse forme di contraccezione altamente efficaci per l’intera durata dello studio e per almeno 30 giorni dopo l’interruzione del farmaco in studio. Le forme medicalmente accettabili di contraccezione efficace comprendono: (1) contraccettivi ormonali approvati (quali pillole anticoncezionali), (2) metodi di barriera (quali preservativo o diaframma) utilizzati unitamente a spermicida, (3) un dispositivo intrauterino (IUD) o (4) vasectomia del partner. Per le donne potenzialmente fertili è richiesto un test di gravidanza sulle urine con esito negativo al Basale (ingresso nello studio) prima di iniziare l’assunzione del farmaco in studio. Per WOCBP si intende qualsiasi persona di sesso femminile che abbia avuto il menarca e che non sia stata sottoposta a sterilizzazione chirurgica con esito positivo (isterectomia, legamento bilaterale delle tube oppure ovariectomia bilaterale) o che non sia in fase di post-menopausa (definita come amenorrea per almeno 12 mesi consecutivi).
    4. I soggetti di sesso maschile che partecipano allo studio devono utilizzare il preservativo per l’intera durata dello studio e per almeno 48 ore dopo l’assunzione dell’ultima dose di farmaco in studio.
    E.4Principal exclusion criteria
    1.The subject is pregnant or lactating. 2.The subject is receiving infused or inhaled prostacyclin therapy. 3.The subject was prematurely discontinued from study TDE-PH-310 for reasons other than a clinical worsening event. 4.The subject developed a concurrent illness or condition during the conduct of TDE PH 310 which, in the opinion of the investigator, would represent a risk to overall health if they enrolled in this study.
    1. Il soggetto è in gravidanza o sta allattando al seno.
    2. Il soggetto sta ricevendo una terapia a base di prostacicline per infusione o inalazione.
    3. Il soggetto ha interrotto precocemente la partecipazione allo studio TDE-PH-310 per motivi diversi da un evento di peggioramento clinico.
    4. Il soggetto ha sviluppato una patologia o condizione concomitante durante la conduzione dello studio TDE PH 310 che, a opinione dello sperimentatore, rappresenterebbe un rischio alla salute generale del soggetto se venisse arruolato in questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical assessments - Efficacy and Safety
    Valutazioni cliniche - Efficacia e Sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: 6MWT- baseline, week 6, week 12 and every 12 weeks thereafter, and at study termination visit Borg Dysphea Score- Following each 6MWT WHO functional Class- baseline, week 6, week 12 and every 12 weeks thereafter, and at study termination visit N-terminal pro BNP- Baseline and week 48 Safety: Vital signs- baseline and at all subsequent protocol-required visits Physical examination- Baseline and study termination visit Clinical Laboratory Assessments- Baseline, week 12, week 24 and at every other follow-up visit thereafter, and at the study termination visit Adverse event assessments- captured from the time the ICF is signed and should be followed for up to 30 days after completion of the study termination visit
    Efficacia:
    6MWT - Basale, sett. 6, 12 e successivamente ogni 12, nonché alla visita conclusiva dello studio
    Punteggio di Borg per valutare la dispnea - Dopo ogni 6MWT
    Classe funzionale dell’OMS - Basale, sett. 6, 12 e successivamente ogni 12, nonché alla visita conclusiva dello studio
    pro BNP N-terminale - Basale e sett. 48
    Sicurezza:
    Parametri vitali - Basale e tutte le visite successive richieste dal protocollo
    Esame obiettivo - Basale e visita di conclusione dello studio
    Valutazioni cliniche di laboratorio - Basale, sett. 12, 24 e quindi ad ogni visita di follow-up successiva, nonché alla visita conclusiva dello studio
    Valutazione degli eventi avversi - Acquisiti dal momento in cui viene firmato ICF e devono essere seguiti fino a 30 gg dalla visita conclusiva
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Australia
    Brazil
    Canada
    Israel
    Korea, Republic of
    Mexico
    Taiwan
    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 study will continue until either oral UT-15C becomes available within the respective territories or the study is discontinued by the sponsor
    Lo studio proseguirà fino a che UT-15C diventa disponibile sul mercato all’interno dei rispettivi territori o finché lo studio viene interrotto dallo sponsor
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 158
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 858
    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 Decision2013-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
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