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    Summary
    EudraCT Number:2010-021037-32
    Sponsor's Protocol Code Number:I4T-MC-JVBB(d)
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-29
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2010-021037-32
    A.3Full title of the trial
    A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine
    Estudo de Fase 3, multicêntrico, com dupla ocultação, aleatorizado sobre o irinotecano, ácido folínico e 5-fluorouracilo (FOLFIRI), juntamente com ramucirumab ou placebo em doentes com carcinoma colo-rectal metastático progressivo durante ou após uma terapêutica combinada de primeira linha com bevacizumab, oxaliplatina e uma fluoropirimidina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for people with advanced colorectal cancer who have been treated with a specific chemotherapy regimen (Bevacizumab, Oxaliplatin, and a Fluoropyrimidine) which was ineffective in stopping the spread of the colorectal cancer. Study participants will receive a different chemotherapy regimen (Irinotecan, Folinic Acid, and 5-Fluorouracil) and be randomly and unknowingly assigned to also receive the study drug (ramucirimab) or a non-active compound (placebo).
    Um estudo para pessoas com carcinoma colo-rectal avançado que foram tratados com um regime de quimioterapia especifico(bevacizumab, oxaliplatina e uma fluoropirimidina)que se mostrou ineficaz em parar a propagaçao do carcinoma colo-rectal. Os participantes do estudo receberao um regime diferente de quimioterapia (Irinotecan, Folinic Acid, and 5-Fluorouracil) e serao aleatorizados tambem para receber o medicamento do estudo(ramucirimab) ou placebo
    A.4.1Sponsor's protocol code numberI4T-MC-JVBB(d)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01183780
    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 SponsorEli Lilly and Company Limited, Indianapolis
    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 supportEli Lilly and Company Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post codeIN 46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number+441276412 6600
    B.5.5Fax number+4412764103247
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRamucirumab DP
    D.3.2Product code IMC-1121B (LY3009806)
    D.3.4Pharmaceutical form 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.3.9.1CAS number 947 687-13-0
    D.3.9.2Current sponsor codeIMC-1121B (LY3009806)
    D.3.9.3Other descriptive namerecombinant human IgG1 monoclonal antibody (MAb) targeted to VEGFR-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 typerecombinant monoclonal antibody
    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.2.1.1.1Trade name Campto
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate 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 INNIRINOTECAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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 typechemotherapy product
    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.2.1.1.1Trade name Calciumfolinat
    D.2.1.1.2Name of the Marketing Authorisation holderHospira Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNFOLINIC ACID
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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.2.1.1.1Trade name Neofluor
    D.2.1.1.2Name of the Marketing Authorisation holderNeoCorp AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 name5-Fluorouracil
    D.3.4Pharmaceutical form Concentrate 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 INN5-FLUOROURACIL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Colorectal Cancer
    carcinoma colo-rectal metastático
    E.1.1.1Medical condition in easily understood language
    bowel cancer
    Carcinoma do intestino
    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 LLT
    E.1.2Classification code 10010036
    E.1.2Term Colorectal carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare overall survival (OS) in patients with metastatic colorectal carcinoma (CRC) when treated with FOLFIRI in combination with placebo versus FOLFIRI in combination with ramucirumab DP.
    O principal objectivo deste estudo é comparar a sobrevivência global (OS - overall survival) em doentes com carcinoma colo-rectal (CCR) metastático quando tratados com FOLFIRI em combinação com placebo versus FOLFIRI em combinação com a SM ramucirumab.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare FOLFIRI plus placebo treatment with FOLFIRI plus ramucirumab DP treatment for:
    • progression-free survival (PFS)
    • objective response rate (ORR)
    • patient-reported outcome (PRO) measures (using European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 and EuroQol EQ 5D)
    • safety profile
    • assessment of the association between biomarkers and clinical outcome

    In addition, secondary objectives include:
    • assessment of anti-ramucirumab antibodies (immunogenicity)
    • assessment of serum levels of ramucirumab
    Os objectivos secundários estão relacionados com a comparação do tratamento com FOLFIRI mais placebo com o tratamento com FOLFIRI mais a SM ramucirumab em relação:
    • à sobrevivência sem progressão de doença (PFS - progression-free survival)
    • a taxa de resposta objectiva (ORR - objective response rate)
    • às medições dos resultados referidos pelos doentes (PRO - patient-reported outcome) (utilizando o QLQ-C30 da Organização Europeia de Investigação e Tratamento do Cancro [OEITC] e o EuroQol EQ 5D)
    • ao perfil de segurança
    • à avaliação da associação entre os biomarcadores e os resultados clínicos
    Para além disso, os objectivos secundários incluem:
    • avaliação dos anticorpos anti-ramucirumab (imunogenicidade)
    • avaliação dos níveis séricos de ramucirumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed metastatic colorectal cancer excluding
    primary tumors of appendiceal origin. (patients are eligible to enroll irrespective of KRAS mutation status)
    - Confirmed metastatic colorectal cancer
    - The patient has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and a)Experienced radiographic disease progression during first-line therapy, or b)Experienced radiographic disease progression < 6 months after the last dose of first-line therapy, or c)Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression < 6 months after the last dose of first-line therapy; Note that a patient must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy
    - Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted)
    - Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1)
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    - Adequate hematologic, renal, hepatic and coagulation function
    - Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers
    - Ability to provide signed informed consent
    Os doentes deverão ter pelo menos 18 anos de idade e deverão ter CCR metastático progressivo durante ou após a terapêutica combinada de primeira linha com bevacizumab, oxaliplatina e uma fluoropirimidina. Os doentes poderão ter uma doença mensurável ou não mensurável com base nos Critérios de Avaliação de Resposta em Tumores Sólidos Versão 1.1 (RECIST - Response Evaluation Criteria in Solid Tumors, v. 1.1) e devem apresentar o estado 0 ou 1 do Eastern Cooperative Oncology Group assim como funções hematológicas, dos órgãos e de coagulação adequadas.
    E.4Principal exclusion criteria
    - Receipt of bevacizumab <28 or has received any radiotherapy ≤14 days prior to
    randomization.
    - Receipt of any investigational therapy < 28 days prior to randomization
    - Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer
    - Known leptomeningeal disease (currently or in the past) or brain metastases or uncontrolled spinal cord compression
    - Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, < 12 months prior to randomization
    - Pregnant (confirmed by serum beta human chorionic gonadotropin [ß HCG] test within 7 days prior to randomization) or lactating
    - History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) in the 12 months prior to randomization
    - Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator
    - Grade 3 or higher bleeding event within 3 months prior to randomization
    - Experience of any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 4 proteinuria, a Grade 3-4 bleeding event, or bowel perforation
    - Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28
    - Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments
    os doentes não podem ter recebido anteriormente mais do que 2 regimes de quimioterapia sistémica, em qualquer cenário, e não podem ter manifestado um evento de hemorragia de Grau 3 ou superior até 3 meses antes da aleatorização, ou um evento trombótico arterial até 12 meses antes da aleatorização. Os doentes não podem ter, igualmente, uma doença intercorrente não controlada, uma doença leptomeníngea (actual ou antiga), metástases cerebrais ou uma infecção activa que necessite de terapêutica parentérica. Por último, os doentes não podem ter recebido bevacizumab no espaço de 28 dias antes da aleatorização.
    E.5 End points
    E.5.1Primary end point(s)
    overall survival
    sobrevivência global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to date of death from any cause
    Baseline à data de morte por qualquer causa
    E.5.2Secondary end point(s)
    Progression-free survival time
    Proportion of patients achieving an objective response
    Change in European Organisation for Research and Treatment of Cancer
    [EORTC] QLQ-C30
    Incidence of anti-ramucirumab antibodies
    Cmax and Cmin of ramucirumab
    Change in EuroQol EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    cause
    ORR: Baseline, every 6 weeks through week 36, then every 12 weeks
    thereafter until disease progression
    QLQ-C30: Every 2 cycles through cycle 14, then every 4 cycles
    Incidence of anti-ramucirumab antibodies: Baseline, 30-day follow-up
    Cmax and Cmin of ramucirumab: Baseline, pre- and post-infusions at
    cycles 3 and 5, and at 30-day follow-up
    EuroQol EQ-5D: Every 2 cycles through cycle 14, then every 4 cycles
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Czech Republic
    Finland
    France
    Germany
    India
    Italy
    Japan
    Korea, Republic of
    Portugal
    Romania
    Spain
    Sweden
    Taiwan
    United States
    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
    Last visit last patient
    Ultima visita ultimo doente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months2
    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.1.1.1In 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: 472
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 578
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 475
    F.4.2.2In the whole clinical trial 1050
    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)
    After termination of study treatment, the patient will be treated as clinically indicated by the investigator or referring physician.
    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 Decision2011-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-01
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