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    Summary
    EudraCT Number:2008-002326-11
    Sponsor's Protocol Code Number:ET-C-002-07
    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:2011-11-22
    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 number2008-002326-11
    A.3Full title of the trial
    A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients with Translocation-Related Sarcomas (TRS)
    STUDIO DI FASE III MULTICENTRO, RANDOMIZZATO SU TRABECTEDINA (YONDELIS) VS CHEMIOTERAPIA CON REGIME CONTENENTE ADRIAMICINA PER IL TRATTAMENTO IN PRIMA LINEA DI PAZIENTI AFFETTI DA SARCOMA ASSOCIATO A TRASLOCAZIONE CROMOSOMICA (TRS).
    A.4.1Sponsor's protocol code numberET-C-002-07
    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 SponsorPHARMA MAR
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yondelis
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/01/039
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrabectedin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDoxorubicin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.3Concentration number75
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIfosfamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.3Concentration number9
    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 Yes
    D.2.1.1.1Trade name Yondelis
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/01/039
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrabectedin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    Translocation-related Sarcomas
    sarcoma associato a traslocazione cromosomica (SAT).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of trabectedin vs. standard doxorubicin-based chemotherapy (DXCT) as first-line treatment of patients with advanced TRS, by comparing progression-free survival (PFS) in each treatment arm.
    Valutare l`efficacia della Trabectedina vs chemioterapia standard basata su Doxorubicina (DXCT) come trattamento di prima linea di pazienti affetti da SAT in fase avanzata, mediante confronto della sopravvivenza libera da progressione (SLP) in ciascun braccio del trattamento.
    E.2.2Secondary objectives of the trial
    To compare 6-month PFS rates. To compare response rates and duration of response, by the Response Evaluation Criteria In Solid Tumors (RECIST). To compare the exploratory computed tomography (CT) evaluations conducted using the Choi response criteria. To compare PFS and response rates in the subgroups of patients stratified by histological type (myxoid - round cell liposarcoma vs. other TRS subtypes). To compare overall survival (OS). To compare the safety profile in each treatment arm. To conduct exploratory, pharmacogenomic (PGx) studies to correlate fusion-protein type and variants, and deoxyribonucleic acid (DNA)repair markers with clinical outcomes.
    Confrontare le percentuali di SLP a 6 mesi.Confrontare le percentuali di risposta e la durata della risposta mediante i criteri RECIST (Response Evaluation Criteria In Solid Tumors).Confrontare le valutazioni della tomografia computerizzata esplorativa (CE) effettuate usando i criteri di risposta Choi.Confrontare le percentuali di SLP e di risposta nei sottogruppi di pazienti stratificati per tipo istologico (liposarcoma mixoide a cellule rotonde vs altri sottotipi di SAT).Confrontare la sopravvivenza globale (SG).Confrontare il profilo di sicurezza in ciascun braccio del trattamento.Condurre studi esplorativi,farmacogenomici (PGx) per correlare il tipo di proteina di fusione e le varianti,e i geniriparatori dell`acido deossiribonucleico (DNA) con i risultati clinici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patient`s written informed consent before any study-specific procedures. 2) Adult patients (age > 18 years). 3) Patients with pathological diagnosis of TRS (institutional assessment), of any, but restricted to the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid - round cell liposarcomas (MRCL) and synovial sarcoma. Availability of adequate tumor material for external review is mandatory. 4)Patients must have unresectable locally advanced or metastatic progressive disease prior to enrolment. 5)Measurable disease as defined by the radiological (CT-scan and MRI) Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines. 6)ECOG PS score of 0-2. 7)Adequate cardiac function, defined as LVEF within normal limits according to institutional standards, as shown by echocardiography or scintigraphy [multiple-gated acquisition scan (MUGA)]. 8)Hematological variables: a)Hemoglobin `‰¥ 9 g/dl. b)Absolute neutrophil count (ANC) `‰¥ 1,500/µl. c)Platelet count `‰¥ 100,000/µl. 9)Biochemical variables: a)Serum creatinine `‰¤ 1.5 mg/dl b)Creatine phosphokinase (CPK) `‰¤ 2.5 x upper limit of normal range of values (ULN). 10)Hepatic function variables: a)Total bilirubin `‰¤ ULN, unless in case of Gilbert`s syndrome b)Total alkaline phosphatase (AP) `‰¤ 2.5 x ULN, or if > 2.5 x ULN consider AP liver fraction, and/or gamma-glutamyltransferase (GGT), and/or 5` nucleotidase must be `‰¤ ULN. c)Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) must be `‰¤ 2.5 x ULN. d)Albumin `‰¥ 25 g/l.
    1) Consenso informato scritto del paziente prima di qualsiasi procedura specifica dello studio. 2) Pazienti adulti (di eta` &gt; 18 anni). 3)Pazienti con diagnosi istologica di SAT (valutazione istituzionale), di qualsiasi ma limitate ai seguenti sottotipi: sarcoma dei tessuti molli alveolare, istiocitoma fibroso angiomatoide, sarcoma a cellule chiare, tumore desmoplastico a cellule rotonde, sarcoma di stroma endometriale di basso grado (consentita precedente terapia ormonale), sarcoma fibromixoide di basso grado, condrosarcoma mixoide, liposarcoma mixoide a cellule rotonde (LMCR) e sarcoma sinoviale. E` obbligatoria la disponibilita` di materiale tumorale adeguato per esame esterno. 4)I pazienti devono essere affetti da malattia progressiva avanzata a livello locale non resecabile o metastatico. 5)Malattia valutabile con tecniche radiologiche (CT Scan e MRI) in accordo con le definizioni delle Linee Guida RECIST 6)Punteggio ECOG PS di 0-2. 7)Funzione cardiaca adeguata, definita come FEVS entro limiti normali secondo gli standard istituzionali, cosi` come mostrato da ecocardiografia o scintigrafia (scansione MUGA). 8)Variabili ematologiche: a)Emoglobina `‰¥ 9 g/dl. b)Conteggio neutrofili in numero assoluto (ANC) `‰¥ 1.500/µl. c)Conteggio piastrine `‰¥ 100.000/µl. 9)Variabili biochimiche: a)Creatinina nel siero `‰¤ 1,5 mg/dl b)Creatina fosfochinasi (CPK) `‰¤ 2,5 x limite superiore del valore normale (ULN). 10)Variabili della funzione epatica: a)Bilirubina totale `‰¤ ULN tranne nel caso di sindrome di Gilbert. b)Fosfatasi alcalina totale (AP) `‰¤ 2,5 x ULN, o se &gt; 2,5 x ULN prendere in considerazione la frazione epatica AP, e/o gamma-glutamiltransferasi (GGT), e/o la 5` nucleotidasi deve essere `‰¤ ULN. c)Aspartate aminotransferasi (AST/SGOT) e alaninoaminotransferasi (ALT/SGPT) devono essere `‰¤ 2,5 x ULN. d)Albumina `‰¥ 25 g/l.
    E.4Principal exclusion criteria
    1) Known hypersensitivity to any components of the intravenous (i.v.) formulation of trabectedin or the comparators. 2) Prior chemotherapy treatment. 3) Prior irradiation of the lesion, if only one target lesion (i.e., measurable) is available. 4) Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods (one or more of the following): a) Complete abstinence from intercourse from two weeks prior to administration of the study treatment, throughout the study, and for at least six months after completion or premature discontinuation from the study to account for elimination of the investigational drug(s); or, b) Physical sterilization of the patient or the patient`s partner; or, c) One of the following, for female patients or female partners of male patients: Implants of levonorgestrel; or, Injectable progestogen; or, Oral contraceptive (combined or progestogen only; patients taking oral contraceptives should have been on a stable regimen for at least two months prior to screening), or, Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, Double barrier method (two physical barriers or one physical barrier plus spermicide); or, Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year. 5) History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more. 6) Brain metastases and/or leptomeningeal metastases, even if treated. 7) Other serious illnesses, such as: a) Congestive heart failure or angina pectoris; myocardial infarction within one year before enrolment; uncontrolled arterial hypertension [according to World Health Organization(WHO) criteria), arrhythmias or abnormal LVEF. 8) Psychiatric disorder or any other personal circumstances that prevent compliance with the study protocol. 9) Active viral hepatitis or chronic liver disease. 10) Active infection. 11) Any other unstable medical condition. 12) Inability or unwillingness to comply with the study protocol. 13) Prior treatment with any investigational drugs/treatments within 30 days before inclusion into the current study.
    1) Ipersensibilita` nota a qualcuno dei componenti della formulazione intravenosa (i.v.) dei Trabectedina o dei comparatori. 2) Trattamento chemioterapico precedente. 3) Irradiazione precedente della lesione, in caso sia disponibile solo la lesione target (cioe`, misurabile). 4) Donne incinte o in fase di allattamento o uomini e donne potenzialmente fertili che non usano metodi contraccettivi efficaci (uno o piu` dei seguenti): a) Astinenza totale da rapporti sessuali a partire da due settimane precedenti la somministrazione del trattamento dello studio, per la durata dello studio e per almeno sei mesi dopo il termine o l`interruzione precoce dello studio in modo da garantire l`eliminazione del/i farmaci dello studio; oppure, b) Sterilizzazione fisica del paziente o del partner del paziente; oppure, c) Uno dei seguenti metodi, per le pazienti di sesso femminile o partner femminili di pazienti di sesso maschile: Applicazioni di levonorgestrelo; oppure, Progestogene iniettabile; oppure, Contraccettivo orale (combinato o solo progestogene; le pazienti che assumono contraccettivi orali devono essere state a regime stabile per almeno due mesi prima dello screening); oppure, Qualsiasi dispositivo intrauterino (IUD) con dati pubblicati che dimostrano che il tasso di fallimento inferiore previsto e` meno dell`1% all`anno (non tutti gli IUD rispettano questo criterio); oppure, Metodo a barriera doppia (due barriere fisiche o una barriera fisica piu` spermicida); oppure, Qualsiasi altro metodo con dati pubblicati che dimostrano che il tasso di fallimento inferiore previsto per tale metodo e` meno dell`1% all`anno. 5) Anamnesi di un`altra malattia neoplastica (tranne il carcinoma cellulare basale o il carcinoma cervicale in situ adeguatamente trattato) a meno che non sia in remissione per cinque anni o piu`. 6) Metastasi cerebrali e/o metastasi leptomeningee, anche se trattate. 7) Altre patologie gravi, tipo: a) Insufficienza cardiaca congestizia o angina pectoris; infarto miocardico entro un anno prima dell`arruolamento; ipertensione arteriosa incontrollata [secondo i criteri del World Health Organization (WHO)), aritmia o FEVS anomala. 8) Disturbi psichiatrici o qualsiasi altra circostanza personale che impedisca il rispetto del protocollo dello studio. 9) Epatite virale attiva o malattia epatica cronica. 10) Infezione attiva. 11) Qualsiasi altra condizione medica instabile. 12) Incapacita` o mancata volonta` di rispettare il protocollo dello studio. 13) Precedente trattamento con qualsiasi farmaco/trattamento dello studio entro i 30 giorni precedenti l`inclusione dello studio attuale.
    E.5 End points
    E.5.1Primary end point(s)
    PFS: will be calculated as the time from the date of randomization to the date of documented PD or death (regardless of the cause of death). If the patient receives further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS will be censored on the date of administration of this antitumor therapy. If the patient is lost to follow-up for the assessment of progression, or has more than one missing follow-up between the date of last tumor assessment and the date of death or further antitumor therapy, the PFS will be censored at the date of last tumor assessment.
    PFS: will be calculated as the time from the date of randomization to the date of documented PD or death (regardless of the cause of death). If the patient receives further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS will be censored on the date of administration of this antitumor therapy. If the patient is lost to follow-up for the assessment of progression, or has more than one missing follow-up between the date of last tumor assessment and the date of death or further antitumor therapy, the PFS will be censored at the date of last tumor assessment.
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.3Elderly (>=65 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 80
    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 Decision2008-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-20
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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