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    Summary
    EudraCT Number:2006-001247-64
    Sponsor's Protocol Code Number:CRAD001C2239
    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:2007-04-16
    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 number2006-001247-64
    A.3Full title of the trial
    An open label, stratified, single-arm phase II study of RAD001 in patients with advanced pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy
    Studio in aperto, stratificato, a braccio singolo, di Fase II con RAD001 in pazienti con tumori pancreatici neuroendocrini (NET) in stadio avanzato dopo fallimento della chemioterapia citotossica.
    A.4.1Sponsor's protocol code numberCRAD001C2239
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNovartis Pharma Services AG
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+ 39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 SANDOSTATINA LAR*FL 10MG+SIR+2
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA *
    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 Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOctreotide
    D.3.9.1CAS number 83150-76-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 SANDOSTATINA LAR*FL 20MG+SIR+2
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA *
    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 Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOctreotide
    D.3.9.1CAS number 83150-76-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 SANDOSTATINA LAR*FL 30MG+SIR+2
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA *
    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 Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOctreotide
    D.3.9.1CAS number 83150-76-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/07/488
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNeverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.2Current sponsor codeRAD001
    D.3.10 Strength
    D.3.10.3Concentration number5
    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
    pancreatic neuroendocrine tumor (NET)
    tumori neuroendocrini del pancreas
    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 PT
    E.1.2Classification code 10055007
    E.1.2Term Carcinoid tumour of the pancreas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective response rate (ORR) (including complete response and partial response) of RAD001 10 mg po qd monotherapy in patients with advanced (unresectable or metastatic) pancreatic NETs after the failure of cytotoxic chemotherapy (stratum 1).
    • Valutare la percentuale di risposta obiettiva (completa o parziale) a RAD001 10 mg, somministrato in monoterapia, una volta al giorno per via orale, in pazienti con tumori pancreatici neuroendocrini in stadio avanzato (non operabili o metastatici) dopo insuccesso della chemioterapia citotossica (strato 1).
    E.2.2Secondary objectives of the trial
    -the response duration of RAD001 10 mg po qd monotherapy (stratum 1). •the objective response rate (ORR) and response duration of RAD001 10 mg po qd plus Sandostatin LAR Depot therapy in patients whose tumors have progressed while receiving Sandostatin LAR Depot therapy and after the failure of cytotoxic chemotherapy (stratum 2). - safety and tolerability of RAD001 monotherapy (10 mg/d) in patients with Pancreatic NET (stratum 1). •-safety and tolerability of the combination of RAD001 (10 mg/d) plus Sandostatin LAR Depot in patients with Pancreatic NET (stratum 2). • - progression free survival (PFS) and the overall survival (OS) of patients receiving RAD001 10 mg per day in combination with Sandostatin LAR and of patients receiving RAD001 10 mg per day monotherapy. • To assess the steady state exposure to RAD001 and to estimate the effect of coadministering Sandostatin LAR Depot on RA
    •Valut la durata della risp a RAD001 10 mg,sommin in monoterapia,1 volta algg per via orale(strato 1).•Valut la % di risp obiettiva e la durata della risp a RAD001 10 mg,sommin una volta algg per via orale,in associazione a Sandostatina LAR Depot,in paz con tumori pancreatici neuroendocrini che hanno presentatoprogr durante la terapia con Sandostatina LAR Depot e dopo insuccesso della chemioterapia citotossica(strato 2).•Valut la sicur.e la toll di RAD001 in monoterap (10 mg/die)in paz con tumori pancreatici neuroendocrini(strato 1).•Valut la sicur.e la toll dell'associazione di RAD001(10 mg/die)e Sandostatina LAR Depot in paz con tumori pancreatici neuroendocrini(strato 2).•Valut la PFS e la sopravvivenza globale(OS)nei paz in terapia con RAD001 10 mg/die in associazione a Sandostatina LAR Depot e nei paz in monoterapia con RAD001 10 mg/die.•Valut l'esposizione a RAD001 allo 'steady state' e l'eff della concomitante sommin di Sandostatina LAR Depot sull'esposizione a RAD001
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI:
    identificazione di indicatori biologici sperimentali

    E.3Principal inclusion criteria
    Adult male or female patients (>=18 years of age). 2. Advanced (unresectable or metastatic) biopsy-proven pancreatic NET documented as follows: • Radiologic, operative, or pathology reports should document a pancreatic location of tumor at some point in the patient's history; • Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Pathology report should state one of the following: carcinoid, islet cell carcinoma, pancreatic endocrine tumor, low-grade or well-differentiated neuroendocrine carcinoma, atypical carcinoid, intermediate-grade or moderately differentiated neuroendocrine carcinoma; • Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma are not eligible. 3. Documented objective progression of disease by RECIST criteria while receiving cytotoxic chemotherapy or documented progression at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen). Previous therapy with alpha interferon or tyrosine kinase inhibitors are allowed but would not be considered to be prior chemotherapy. Objective progression of disease must be documented by RECIST criteria. Any of the following would be sufficient according to RECIST: • a 20% increase in the sum of unidimensionally measured target lesions; • a new lesion; • unequivocal increase in non -measurable disease.
    1.Entrambi i sessi ed eta' &gt;= 18 anni. 2.Pazienti con tumore pancreatico neuroendocrino in stadio avanzato (non operabile o metastatico), confermato da biopsia, in base ai seguenti criteri: - La localizzazione pancreatica del tumore deve essere documentata in anamnesi dai referti radiologici o da altri referti medici; - I pazienti devono avere un carcinoma neuroendocrino confermato di grado basso o intermedio. I referti patologici devono riportare: carcinoide, carcinoma a cellule insulari, tumore pancreatico endocrino, carcinoma neuroendocrino a basso grado di differenziazione o ben differenziato, carcinoide atipico, carcinoma neuroendocrino di grado intermedio di differenziazione o moderatamente differenziato. - I pazienti con carcinoma neuroendocrino scarsamente differenziato, carcinoma neuroendocrino ad alto grado di differenziazione, adenocarcinoide, carcinoide a cellule caliciformi e carcinoma a piccole cellule non sono eligibili allo studio. 3.Progressione obiettiva documentata della malattia in base ai criteri RECIST durante chemioterapia citotossica o progressione documentata in qualsiasi momento dopo aver ricevuto un adeguato trattamento con chemioterapia citotossica (tre cicli consecutivi o almeno 3 mesi di trattamento con lo stesso regime chemioterapico). La terapia precedente con interferone-alfa o inibitori della tirosin chinasi e' consentita ma non sara' considerata come precedente chemioterapia. Progressione obiettiva della malattia in base ai criteri RECIST (sara' sufficiente la presenza di uno dei criteri seguenti: aumento del 20% della somma delle lesioni target (misurazione unidimensionale); presenza di una lesione nuova; aumento inequivocabile della malattia non misurabile.
    E.4Principal exclusion criteria
    Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, surgery or radiotherapy. Investigational agents used solely for imaging purposes are permissible if deemed safe and acceptable by local review authorities. Sandostatin LAR Depot is allowed in stratum 2. 2. Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation of hepatic metastasis within 2 months of enrollment. 3. Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus). 4. Patients with uncontrolled diabetes mellitus as defined by fast blood sugar > 1.5 x ULN. 5. Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis. 6. Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy. 7. No other prior or concurrent malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years. 8. Known history of immunocompromise, including a positive HIV test. An HIV test will not be required; however, previous medical history will be reviewed. 9. Pregnant or nursing (lactating) women. Unless demonstrated to be post-menopausal (see inclusion criteria), pregnancy should be excluded by serum pregnancy test. 10. Concomitant medications known to inhibit, induce or be a substrate to isoenzyme CYP3A are excluded unless the drugs are medically necessary and no substitutes are available. If there are no acceptable substitutes, special precautions should be taken in these patients.
    1.Terapia antitumorale nelle 3 settimane precedenti l'arruolamento, comprendendo la chemioterapia, la terapia ormonale, l'immunoterapia, la chirurgia e la radioterapia. La Sandostatina LAR Depot e' consentita nei pazienti dello strato 2. 2.Embolizzazione dell'arteria epatica nei 6 mesi precedenti (1 mese se sono presenti altre sedi di malattia misurabile) o crioablazione di metastasi epatiche nei 2 mesi precedenti l'arruolamento. 3.Terapia precedente con RAD001 (everolimus) o altre rapamicine (sirolimus, temsirolimus). 4.Diabete mellito non controllato, definito dalla presenza di glicemia a digiuno &gt; 1,5 x ULN. 5.Epatopatie quali cirrosi, epatite cronica attiva o epatite cronica persistente. 6.Infezioni gravi intercorrenti o patologie non maligne non controllate o il cui controllo puo' essere compromesso dalle complicanze della terapia dello studio. 7.Altre patologie maligne precedenti o concomitanti, escludendo adenocarcinoma a cellule squamose della cute o altro carcinoma in situ adeguatamente trattato od ogni altro carcinoma per il quale il paziente e' stato 5 anni libero da progressione. 8.Anamnesi positiva per immunocompromissione, compresa la sieropositivita' HIV. Il test HIV non e' richiesto, tuttavia, sara' necessario eseguire un'anamnesi accurata. 9.Gravidanza e allattamento. Donne potenzialmente fertili che non praticano un metodo contraccettivo efficace. Le donne potenzialmente fertili devono aver eseguito un test di gravidanza sul siero prima del trattamento in studio. Sono ammesse le donne in post-menopausa confermata (vedi criteri di inclusione). 10.Trattamento con farmaci noti inibitori, induttori o substrato degli isoenzimi del sistema CYPA3 a meno che tale trattamento non sia assolutamente necessario e non esistano alternative (in questo caso sara' necessario osservare particolare cautela).
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (CR + PR)
    Percentuale di risposta obiettiva (CR + PR)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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 months28
    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 months28
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 144
    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 Decision2006-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-13
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