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    Summary
    EudraCT Number:2015-005548-32
    Sponsor's Protocol Code Number:CCD-06001AA1-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-005548-32
    A.3Full title of the trial
    A 24-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO AND ACTIVE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 4 DOSES OF CHF 6001 DPI IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ON A BACKGROUND THERAPY.
    TRWAJĄCE 24 TYGODNIE, WIELOOŚRODKOWE, RANDOMIZOWANE, PODWÓJNIE ZAŚLEPIONE, PODWÓJNIE MASKOWANE, KONTROLOWANE Z UŻYCIEM SUBSTANCJI AKTYWNEJ I PLACEBO BADANIE KLINICZNE PROWADZONE W GRUPACH RÓWNOLEGŁYCH Z RÓŻNYMI DAWKAMI, MAJĄCE NA CELU OCENĘ SKUTECZNOŚCI ORAZ BEZPIECZEŃSTWA 4 DAWEK CHF 6001 DPI U PACJENTÓW CHORYCH NA PRZEWLEKŁĄ OBTURACYJNĄ CHOROBĘ PŁUC (POCHP), PRZYJMUJĄCYCH LECZENIE PODSTAWOWE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in Chronic Obstructive Pulmonary Disease patients to evaluate the efficacy and safety of 4 different doses of a new medicine, CHF 6001 given for 6 months
    Badanie u pacjentów chorych na przewlekłą obturacyjną chorobę płuc mające ocenić skuteczność oraz bezpieczeństwo stosowania 4 dawek nowego leku, CHF 6001, podawanego przez okres 6 miesięcy.
    A.4.1Sponsor's protocol code numberCCD-06001AA1-01
    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 SponsorChiesi Farmaceutici S.p.A.
    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 supportChiesi Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.A.
    B.5.2Functional name of contact pointCLINICAL PROJECT MANAGER
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.4Telephone number+331 47 68 48 59
    B.5.6E-mailclinicaltrials_info@chiesi.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 nameCHF 6001 NEXThaler 100µg
    D.3.2Product code CHF 6001
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHF 6001 NEXThaler DPI
    D.3.9.2Current sponsor codeCHF6001.00
    D.3.9.4EV Substance CodeSUB180242
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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.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 Pulmicort Turbohaler 200
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    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 Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.3.1Product nameCHF 6001 NEXThaler 400µg
    D.3.2Product code CHF 6001
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHF 6001 NEXThaler DPI
    D.3.9.2Current sponsor codeCHF6001.00
    D.3.9.4EV Substance CodeSUB180242
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 nameCHF 6001 NEXThaler 300µg
    D.3.2Product code CHF 6001
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHF 6001 NEXThaler DPI
    D.3.9.2Current sponsor codeCHF6001.00
    D.3.9.4EV Substance CodeSUB180242
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    E.1.1.1Medical condition in easily understood language
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    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 trial will be to investigate the dose-response relationship of 4 doses of CHF 6001 DPI with respect to predose FEV1 after 12 weeks of treatment and to identify the optimal dose of CHF 6001 for further development in the target patient population.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of the different doses of CHF 6001 DPI in comparison with placebo on other lung function parameters (pre-dose FVC, IC), on symptoms benefit (TDI, SGRQ score, E-RS scores, rescue use) and on exacerbations reduction after 24 weeks of treatment;
    - To evaluate the effect of CHF 6001 in comparison with ICS;
    - To monitor for safety and tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female aged ≥40 years with written informed consent.
    2.A female is eligible to enter the study if she is of non- childbearing potential i.e. physiologically incapable of becoming pregnant or woman permanently sterilized
    3.With an established diagnosis of COPD (according to GOLD guidelines, revised 2015(1)) at least 12 months prior to the screening visit.
    4.With a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20]. Current and ex-smokers are eligible.
    5.With a post-bronchodilator FEV1 >/=30% and </=70% of the patient predicted normal value and a post-bronchodilator FEV1/FVC ratio <0.7 measured 10 to 15 min after administration of 400µg (4 puffs x 100µg) of salbutamol pMDI.
    6.With a documented history (e.g. medical record verification) of at least 1 moderate or severe exacerbation in the 12 months prior to study entry.
    7.Patients must be symptomatic at screening defined as having a MMRC score ≥2 and a CAT score ≥10.
    8.Patients must be receiving daily maintenance therapy with an ICS/LABA only, at stable dose and dosage regimen, for at least 2 months prior to screening.
    9.Patients must have a cooperative attitude and ability to be trained to use correctly the DPI inhalers.
    10.Patients must have a cooperative attitude and ability to be trained to use correctly the electronic devices with COPD questionnaire, to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres, ) and ability to understand the risks involved.
    E.4Principal exclusion criteria
    1. A diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation
    2.On maintenance bronchodilators therapy only (LABA alone, LAMA alone, dual LABA/LAMA) within 8 weeks prior to screening.
    3.On maintenance triple therapy (ICS/LABA plus LAMA), or LAMA plus ICS combination therapy, or on PDE4 inhibitors (e.g. roflumilast) within 8 weeks prior to screening.
    4.Moderate or severe COPD exacerbation or a lower respiratory tract infection within 6 weeks prior to study entry or during the run-in period.
    5.Requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
    6.Participating to a pulmonary rehabilitation programme or completing such a programme within the last 6 weeks prior to screening.
    7.Known respiratory disorders other than COPD that in the investigator’s opinion would affect efficacy and safety evaluation or place the patient at risk.
    8.Lung cancer or a history of lung cancer.
    9.Active cancer or a history of cancer with less than 5 years disease free survival time. Localized carcinoma is acceptable.
    10.A history of hypersensitivity to β2-agonist, corticosteroids, PDE4 inhibitors or any of the excipients contained in any of the formulations used in the trial.
    11.Diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour that might, according to the investigator judgement, place the patient at undue risk.
    12.Clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to study entry, not controlled with a rate control strategy.
    13.Clinically significant abnormal 12-lead ECG that, in the investigator’s opinion, would affect efficacy or safety evaluation or place the patient at risk.
    14.Serum potassium value ≤3.5 mEq/L or >5.5mEq/L and/or a fasting serum glucose value ≥ 140 mg/dL.
    15.History or symptoms of significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances.
    16.Unstable concurrent disease or other disease or condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
    17.Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
    18.Abnormal ALT ≥2x upper limit of normal (ULN) and/ or AST ≥2x ULN and/or bilirubin ≥1.5x ULN. Isolated bilirubin ≥1.5x ULN is acceptable if fractionated and direct bilirubin is <35%.
    19.Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
    20.Receiving treatment with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) within the previous 3 months before the screening visit.
    21.Severely obese (BMI ≥35 kg/m2) or have experienced excessive weight loss recently.
    22.History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
    23.Received any other investigational drug within the preceding 30 days (60 days for biologics), or a longer and more appropriate time as determined by the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable
    •Change from baseline in morning predose FEV1 at week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Secondary efficacy variables
    •Change from baseline in morning predose FEV1.
    •Change from baseline in morning predose morning FVC and IC.
    •TDI score at all visits and proportion of patients with a TDI ≥1 unit
    •Change from baseline to all visits in SGRQ total score and domain scores and proportion of patients with a change from baseline in SGRQ score ≥ -4 units.
    •Moderate and severe COPD exacerbation rate over 24 weeks of treatment.
    Time to first moderate or severe COPD exacerbation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Double dummy
    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 trial6
    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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Bulgaria
    Germany
    Hungary
    Poland
    Romania
    Russian Federation
    Ukraine
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 734
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 367
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The Investigator will obtain written consent from each subject or subject’s legal rep. prior to any study related procedures, this will be collected from the patient or legal rep. after the study has been fully explained by the investigator.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state360
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 1102
    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)
    At completion of subject’s study participation, it is under the Investigator’s responsibility to prescribe the most appropriate treatment for the subject or to restore the initial therapy or to refer to the General Practitioner
    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 Decision2016-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-09
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