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    Summary
    EudraCT Number:2014-000770-19
    Sponsor's Protocol Code Number:D5740C00001
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-27
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2014-000770-19
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating
    the Safety and Efficacy of Roxadustat for the Treatment of Anemia in
    Chronic Kidney Disease Patients not on Dialysis
    Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované skúšanie vo fáze 3, ktorého cieľom je zhodnotiť bezpečnosť a účinnosť roxadustatu pri liečbe anémie u nedialyzovaných pacientov s chronickým ochorením obličiek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy study of roxadustat to treat anemia in patients with chronic kidney disease (CKD), not on dialysis.
    Zhodnotenie bezpečnosti a účinnosti roxadustatu pri liečbe anémie u nedialyzovaných pacientov s chronickým ochorením obličiek.
    A.4.1Sponsor's protocol code numberD5740C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02174627
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1154-2636
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilminton
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@astrazeneca.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.3.2Product code AZD9941
    D.3.4Pharmaceutical form Film-coated 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 INNRoxadustat
    D.3.9.1CAS number 808118-40-3
    D.3.9.2Current sponsor codeAZD9941
    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: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AZD9941
    D.3.4Pharmaceutical form Film-coated 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 INNRoxadustat
    D.3.9.1CAS number 808118-40-3
    D.3.9.2Current sponsor codeAZD9941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AZD9941
    D.3.4Pharmaceutical form Film-coated 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 INNRoxadustat
    D.3.9.1CAS number 808118-40-3
    D.3.9.2Current sponsor codeAZD9941
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia in chronic kidney disease patients without dialysis.
    E.1.1.1Medical condition in easily understood language
    Anemia in patients with severe renal disease without dialysis.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076410
    E.1.2Term Chronic kidney disease stage 3
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076412
    E.1.2Term Chronic kidney disease stage 5
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076411
    E.1.2Term Chronic kidney disease stage 4
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Efficacy Objective: Evaluate the efficacy of roxadustat compared to placebo for the treatment of anemia in CKD subjects not on dialysis.
    Primary Safety Objective: Contribute CV safety data to pooled safety analyses across the phase 3 program
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objectives:
    - The efficacy of roxadustat compared to placebo based on Hb response and level during the study
    - The efficacy of roxadustat compared to placebo based on Hb response in inflamed subjects
    - The effect of roxadustat compared to placebo on Low-density lipoprotein (LDL) cholesterol
    - The need for rescue therapy in subjects treated with roxadustat as compared to placebo
    - The effect of roxadustat on anemia symptoms and health-related quality of life (HRQoL) based on comparison with placebo
    - The effect on the CKD progression of roxadustat as compared to placebo

    Secondary Safety Objectives:
    - To evaluate the safety and tolerability of roxadustat.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provision of informed consent prior to any study specific procedures
    2) Age ≥18 years.
    3) A glomerular filtration rate (eGFR) <60 mL/min/1.73 m2,
    corresponding to stage 3, 4 or 5 chronic kidney disease (CKD) according
    to the Kidney Disease Outcomes Quality Initiative, not receiving dialysis.
    4) Mean of 2 most recent central laboratory hemoglobin (Hb) values
    during the screening period, obtained at least 7 days apart, must be
    <10.0 g/dL.
    5) Ferritin ≥50 ng/mL at randomization.
    6) Transferrin saturation ≥15% at randomization.
    7) Serum folate level ≥ lower limit of normal (LLN) at randomization.
    8) Serum vitamin B12 level ≥LLN at randomization.
    9) Alanine aminotransferase and aspartate aminotransferase ≤3 x upper
    limit of normal (ULN) and total bilirubin ≤1.5 x ULN at randomization.
    10) Body weight 45 to 160 kg.
    E.4Principal exclusion criteria
    1) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    2) Previous randomization in the present study
    3) Any erythropoietin analogue treatment within 6 weeks of randomization.
    4) New York Heart Association Class III or IV congestive heart failure at enrollment
    5) Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization 6) History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver)
    7) Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD.
    8) Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis).
    9) Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. computerized tomography scan or magnetic resonance imaging conducted at screening or within 12 weeks prior to randomization.
    10) Systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may be rescreened once BP controlled.
    11) History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
    12) Positive for any of the following: human immunodeficiency virus, hepatitis B surface antigen or anti-hepatitis C virus antibody.
    13) Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia.
    14) Known hemosiderosis, hemochromatosis or hypercoagulable condition
    15) Any prior organ transplant or a scheduled organ transplantation date
    16) Any red blood cell transfusion (RBC) during the screening period
    17) Any current condition leading to active significant blood loss.
    18) Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
    19) Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of investigation product in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded).
    20) History of alcohol or drug abuse within 2 years prior to randomization.
    21) Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
    22) Pregnant or breastfeeding females.
    23) Known allergy to the investigational product or any of its ingredients.
    24) Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment or may interfere with study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    US FDA: The primary efficacy endpoint for the US is the mean change from baseline in Hb averaged over week 28 to week 52.
    EU health authorities: The primary efficacy endpoint is whether patients achieved Hb response (Yes/No) where Yes is defined as: o Hb ≥ 11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL, for subjects with baseline Hb > 8.0 g/dL;
    or
    o Hb increase from baseline by ≥ 2.0 g/dL, for subjects with baseline Hb ≤ 8.0 g/dL at two consecutive visits [dates] (with available data) separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (RBC transfusion, ESA, or IV iron) prior to Hb response.
    Primary Safety Endpoint:
    Adjudicated CV safety data. Analyses of the adjudicated events are described in a separate pooled statistical analysis plan.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Endpoint:
    US FDA: From week 28 to week 52.
    EU health authorities: From week 0 to week 24.

    Primary Safety Endpoint:
    Analyses of the adjudicated events are described in a separate pooled statistical analysis plan.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    1) Hb response as noted for EU Primary Endpoint.
    2) Mean change in Hb from baseline to the subjects mean level between week 28 to week 52 in subjects with baseline high-sensitivity C-reactive protein (hsCRP) greater than the Upper Limit Normal (ULN)
    3) Proportion of total time of Hb ≥ 10 g/dL from week 28 to week 52.
    4) Proportion of total time of Hb within the interval of 10-12 g/dL from week 28 to week 52
    5) Mean change in LDL cholesterol from baseline to week 24
    6) Time-to-first (and proportion of subjects receiving) instance of receiving intravenous (IV) iron, red blood cell (RBC) transfusions, or erythropoietin analogue as rescue therapy.
    7) Time-to-first (and proportion of subjects receiving) instance of receiving red blood cell (RBC) transfusions as rescue therapy.
    8) Change from baseline in SF-36 Vitality (VT) sub-score
    9) Annual rate of eGFR change in log scale, calculated as the linear slope of log (eGFR values) to prior to initiation of dialysis/kidney transplant
    10) Change from baseline in SF-36 Physical Functioning (PF) sub-score
    Secondary Safety Endpoints:
    Adverse events (AEs), serious adverse events (SAEs).
    Changes in vital signs, electrocardiogram (ECG) and laboratory values.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy Endpoints
    1) From randomization to week 24
    2) From week 28 to week 52
    3) From week 28 to week 52
    4) From week 28 to week 52
    5) From randomization to week 24
    6) From the first date of study drug (SD) intake to EOS for subjects without SD discontinuation (SDD) or to the last date plus 28 days of SD intake for SDD subjects.
    7) From the first date of study drug (SD) intake to EOS for subjects without SD discontinuation (SDD) or to the last date plus 28 days of SD intake for SDD subjects.
    8) From week 12 to week 28
    9) From randomization to EOS for subjects without initiation of
    Dialysis/Transplant (ID/T) or to the date of ID/T for subjects having these renal events.
    10) From week 12 to week 28
    Safety Endpoints:
    From date of first dose of SD to 28 days after last dose of SD
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Evaluate self-reported health status.
    Evaluate the need for rescue therapy.
    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) No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Germany
    Hungary
    India
    Italy
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days15
    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: 1300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1300
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 2600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    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 Decision2014-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-04
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