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    Summary
    EudraCT Number:2011-002792-42
    Sponsor's Protocol Code Number:RV-FOL-GELARC-0683
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-11
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-002792-42
    A.3Full title of the trial
    A phase 3 open label randomized study to compare the efficacy and safety of rituximab plus lenalidomide ( CC-5013) versus rituximab plus chemotherapy followed by rituximab in subjects with previously untreated follicular lymphoma.
    Etude multicentrique, de phase III, randomisée en ouvert, visant à comparer l’efficacité et la tolérance d’un traitement associant le lenalidomide et le rituximab à un traitement associant une chimiothérapie à du rituximab suivi de rituximab en maintenance chez des patients atteints d’un lymphome folliculaire non antérieurement traité.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the efficacy and safety of rituximab plus lenalidomide versus standart therapy with rituximab plus chemotherapy in subjects with prevously untreated follicular lymphoma.
    Etude visant à comparer l'efficacité et la tolérance d'un traitement associant le rituximab plus lenamidomide au traitement standard associant une chimiotherapie à du rituximab chez des patients atteints d'un lymphome folliculaire non antérieurement traité.
    A.3.2Name or abbreviated title of the trial where available
    RELEVANCE
    A.4.1Sponsor's protocol code numberRV-FOL-GELARC-0683
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene international Sarl
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportLYSARC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointManon Croix
    B.5.3 Address:
    B.5.3.1Street AddressCentre Hospitalier Lyon Sud - Bâtiment 2D
    B.5.3.2Town/ cityPIERRE BENITE Cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472669333
    B.5.5Fax number+33426074055
    B.5.6E-mailaffaires-reglementaires@lysarc.org
    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 Revlimid 5mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.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 Revlimid 10mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namelenalidomide
    D.3.2Product code cc-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 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 Revlimid 15mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namelenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namelenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Yes
    D.2.1.1.1Trade name Revlimid 2.5mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namelenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.9.3Other descriptive nameSUB25389
    D.3.9.4EV Substance CodeSUB25389
    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
    stage II-IV follicular lymphoma grade 1-3a not previously treated
    lymphome folliculaire grade 1 à 3a, de stade II à IV non antérieurement traité
    E.1.1.1Medical condition in easily understood language
    follicular lymphoma in need of treatment
    lymphome folliculaire nécessitant un traitement
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10016908
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10016910
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10016909
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III stage III
    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
    The primary objective of the study is to compare the efficacy of rituximab plus lenalidomide to rituximab plus chemotherapy followed by rituximab in patients with previously untreated follicular lymphoma. Efficacy determination will be based upon the co-primary endpoints of complete response (CR/CRu) rate at 120 weeks and PFS assessed by the IRC using the IWG (Cheson, 1999) criteria.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    To compare the efficacy of rituximab plus lenalidomide versus rituximab
    plus chemotherapy followed by rituximab using other parameters of
    efficacy:
    o Complete Response (CR) at 120 weeks by IWG 1999, Event
    Free Survival (EFS) by IWG 1999, Time to Next Anti-Lymphoma
    Treatment (TTNLT), and Overall Survival (OS).
    To compare the safety of rituximab plus lenalidomide versus rituximab
    plus chemotherapy followed by rituximab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The exploratory objectives of the study are:
    • CR rate at 120 weeks, Overall Response Rate at 120 weeks by IWG 1999 Criteria and PFS by 2007 Revised Response Criteria for
    Malignant Lymphoma incorporating FDG-PET (Cheson, 2007)
    • Time to Treatment Failure (TTF)
    • Time to Next Chemotherapy Treatment (TTNCT)
    • Histological transformation rate at first progression
    • To explore the relationship between lenalidomide exposure and
    response (hematology, biomarkers, and other clinical outcomes as
    appropriate).
    • To compare the effects of rituximab plus lenalidomide versus
    rituximab plus chemotherapy followed by rituximab on minimal residual
    disease using PCR detection of the t(14;18) translocation in peripheral
    blood or other MRD assays.
    • To compare the effects of rituximab plus lenalidomide versus
    rituximab plus chemotherapy followed by rituximab on immune
    competence
    • Evaluate Fc-gamma receptor polymorphisms in blood samples
    collected pre-treatment and correlate with clinical outcomes
    • To investigate potential predictive biomarkers of clinical response or
    resistance to rituximab plus lenalidomide, including, but not limited to,
    gene expression, analysis of acquired chromosomal aberrations
    (translocations, gains, deletions, single nucleotide polymorphisms,
    mutations), microRNA and protein expression in archival diagnostic or
    fresh tumor samples
    • Health related quality of life as measured by the EORTC QLQ-C30
    To examine utility during the active, maintenance, and follow-up phases
    using the EQ-5D for the purpose of collecting information on the
    treatment regimens to support cost-effectiveness analyses and
    modeling.
    E.3Principal inclusion criteria
    -Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a
    -Have no prior systemic treatment for lymphoma.
    -Must be in need of treatment
    -Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated.
    -Stage II, III or IV disease.
    -Must be ≥ 18 years and sign an informed consent.
    -Performance status ≤ 2 on the ECOG scale.
    -Adequate hematological function
    -Females of childbearing potential (FCBP) receiving lenalidomide must
    have two negative pregnancy tests . She must agree to ongoing pregnancy testing during the course of the study, and after end of study
    therapy.
    -Male patients receiving lenalidomide must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug
    discontinuation
    -All patients receiving lenalidomide must have an understanding that the
    study drug could have a potential teratogenic risk.
    -For all patients receiving Rituximab Women must not breast feed and
    must use effective contraception must not be pregnant and agree not to become pregnant during participation in the trial and during the 6 months thereafter. Men must agree not to father a child during
    participation in the trial and during the 6 months thereafter.
    E.4Principal exclusion criteria
    -Clinical evidence of transformed lymphoma by investigator assessment
    -Grade 3b follicular lymphoma
    -Patients taking corticosteroids during the last 4 weeks
    -Major surgery within 28 days prior to signing informed consent
    -Seropositive for or active viral infection with hepatitis B virus (HBV)
    -Known seropositive for, or active infection hepatitis C virus (HCV)
    -Known seropositive for, or active viral infection with HIV
    -Life expectancy < 6 months
    -Known sensitivity or allergy to murine products
    -Prior history of malignancies, unless the subject has been free of the
    disease for ≥ 10 years. Exceptions include a history of previously treated Localized non-melanoma skin cancer or Carcinoma in situ of the cervix
    -Prior use of lenalidomide
    -Neuropathy > Grade 1
    -Presence or history of CNS involvement by lymphoma
    -Patients who are at a high risk for a thromboembolic event and are not
    willing to take venous thromboembolic (VTE) prophylaxis
    -Uncontrolled intercurrent illness
    -Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
    -Pregnant or lactating females
    -Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.
    E.5 End points
    E.5.1Primary end point(s)
    The tumor response data will be assessed by the IRC using the IWG ( Cheson 1999) criteria. Based on the CT/MRI schedule, any assessments in a time window of 120 weeks +/-4 weeks are qualified as the 120 weeks assessments. If two of more assessments are performed in this time window, the assessment wtih the least favorable response will be used. PFS is an accepted endpoint of clinical benefit for previously untreated FL patient and was the basis for the recent approval of rituximab maintenance in this population ( Salles 2011). The disease progression status will be assessed by IRC using the IWG (cheson 1999) criteria.
    PFS is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of laste visit with adequate assessement. if a subject received other anti-cancer treatment for follicular lymphoma before progression, the CT/MRI assessments should continue as scheduled until disease progression or death which will be counted as events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    (CR/CRu) rate at 120 weeks
    - First interim analysis when the first 200 patients have their response
    assessment done at 6 months
    - Second interim analysis when the first 200 patients have their
    response assessment done at 120 weeks
    - Primary analysis will be performed when all randomized patients have
    their response assessment done at 120 weeks
    PFS:
    - interim analysis at the time-point when the co-primary endpoint
    CR/CRu rate at 120 weeks is reported, i.e. when all randomized patients
    have their response assessment done at 120 weeks
    - final analysis at the time-point when the required 456
    progression/relapse/death events have occurred among all randomized
    patients
    E.5.2Secondary end point(s)
    •Complete Response (CR)
    •Event Free Survival (EFS)
    •Time to Next Anti-Lymphoma Treatment (TTNLT),
    •Overall Survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    (CR) at 120 weeks
    (EFS) will be measured from the date of randomization to the date of
    first documented progression, relapse, and initiation of a new antilymphoma treatment or death by any cause.
    (TTNLT) will be measured from the date of randomization to the date of
    first documented administration of any new anti-lymphoma treatment
    (chemotherapy, radiotherapy, radio-immunotherapy, immunotherapy).
    (OS) will be measured from date of randomization to the date of death.
    Patients who die, regardless of the cause of death, will be considered to
    have had an event. Patients who withdraw consent for the study will be
    considered censored at the time of withdrawal.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    quality of life
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Belgium
    Canada
    France
    Germany
    Italy
    Portugal
    Spain
    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 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 years13
    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 years13
    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.1.1.1In 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: 649
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 382
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 727
    F.4.2.2In the whole clinical trial 1031
    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)
    Patients will be treated according to local practice.
    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 Decision2012-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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