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    Summary
    EudraCT Number:2015-002619-14
    Sponsor's Protocol Code Number:1199.36
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-002619-14
    A.3Full title of the trial
    A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
    Étude randomisée, réalisée en double aveugle sur des groupes parallèles, comparant l’efficacité et l’innocuité du nintedanib associé au sildénafil administrés par voie orale à celles du nintedanib administré seul, pendant 24 semaines de traitement chez des patients atteints de fibrose pulmonaire idiopathique (FPI) avec une détérioration avancée de la fonction pulmonaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairment
    L'efficacité et l'innocuité du traitement combiné par le nintedanib et le sildénafil chez les patient atteints d'IPF avec une détérioration avancée de la fonction pulmonaire.
    A.4.1Sponsor's protocol code number1199.36
    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 SponsorBoehringer Ingelheim France
    B.1.3.4CountryFrance
    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 supportBoehringer Ingelheim
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1123
    D.3 Description of the IMP
    D.3.1Product nameOfev 100 mg capsule
    D.3.2Product code nintedanib
    D.3.4Pharmaceutical form Capsule, soft
    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 INNnintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    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.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 Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1123
    D.3 Description of the IMP
    D.3.1Product nameOfev 150 mg capsule
    D.3.2Product code nintedanib
    D.3.4Pharmaceutical form Capsule, soft
    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 INNnintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Revatio
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameRevatio 20 mg
    D.3.2Product code sildenafil
    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 INNSILDENAFIL
    D.3.9.1CAS number 139755-83-2
    D.3.9.3Other descriptive namesildenafil
    D.3.9.4EV Substance CodeSUB10517MIG
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
    Patients atteints de fibrose pulmonaire idiopathique (FPI) avec une détérioration avancée de la fonction pulmonaire
    E.1.1.1Medical condition in easily understood language
    Idiopathic pulmonary fibrosis
    Fibrose pulmonaire idiopathique
    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 PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in IPF patients with advanced lung function impairment.
    Evaluation de l’efficacité et de l’innocuité du traitement combiné par le nintedanib et le sildénafil chez des patients atteints de FPI avec une détérioration avancée de la fonction pulmonaire.
    E.2.2Secondary objectives of the trial
    To enlarge the existing nintedanib mono-therapy database with safety and tolerability data in this population.
    Compléter les données disponibles sur l’innocuité et la tolérance du nintedanib en monothérapie dans cette population de patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed (including any required washout);
    2. Male or female patients aged ≥40 years at visit 1;
    3. A clinical diagnosis of IPF within the last 6 years before visit 1, based upon the ATS/ERS/JRS/ALAT 2011 guideline;
    4. Combination of high-resolution computed tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with a diagnosis of IPF as assessed by the investigator based on a HRCT scan performed within 18 months of visit 1;
    5. DLCO (corrected for Hb) ≤ 35% predicted of normal at visit 1.
    1.Signature du consentement écrit ;
    2.Hommes/femmes ≥40 ans à la visite V1 ;
    3.Diagnostic clinique de la FPI dans les 6 ans précédents la visite V1 selon les recommandations ATS/ERS/JRS/ALAT 2011 ;
    4.Présence des caractéristiques typiques de l’FPI (listées dans l’appendice 10.1 du protocole) :
    –sur un Scanner pulmonaire (High Resolution Computed Tomography) dans les 18 mois avant V1
    –et sur les biopsies pulmonaires (si disponibles)
    5.Dlco (corrigée par Hg) ≤ 35 % de la valeur prédictive normale lors de V1.
    E.4Principal exclusion criteria
    1. Previous enrolment in this trial;
    2. ALT, AST > 1.5 fold upper limit of normal (ULN) at visit 1;
    3. Total bilirubin > 1.5 fold ULN at visit 1;
    4. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7 at visit 1);
    5. History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1;
    6. Bleeding Risk: - Known genetic predisposition to bleeding; - Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin, etc.) or high dose antiplatelet therapy; - History of haemorrhagic central nervous system (CNS) event within 12 months prior to visit 1; - History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to visit 1; - International normalised ratio (INR) > 2 at visit 1; - Prothrombin time (PT) and activated partial thromboplastin time (aPTT) > 150% of institutional ULN at visit 1;
    7. Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery;
    8. History of thrombotic event (including stroke and transient ischemic attack) within 12 months of visit 1;
    9. Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula at visit 1;
    10. Presence of aortic stenosis (AS) per investigator judgement at visit 1;
    11. Severe chronic heart failure: defined by left ventricular ejection fraction (EF) < 25% per investigator judgement at visit 1;
    12. Presence of idiopathic hypertrophic subaortic stenosis (IHSS) per investigator judgement at visit 1; 13. Second-degree or third-degree atrioventricular (AV) block on electrocardiogram (ECG) per investigator judgement at visit 1;
    14. Hypotension (systolic blood pressure [SBP] < 100 mm Hg or diastolic blood pressure [DBP] < 50 mm Hg) (symptomatic orthostatic hypotension) at visit 1;
    15. Uncontrolled systemic hypertension (SBP > 180 mmHg; DBP > 100 mmHg) at visit 1;
    16. Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose to priapism;
    17. Retinitis pigmentosa;
    18. History of vision loss;
    19. History of nonarteritic ischemic optic neuropathy;
    20. Veno-occlusive disease;
    21. History of acute IPF exacerbation or respiratory infection within 8 weeks of visit 2.
    22. Treatment with nitrates, n-acetylcysteine, pirfenidone, azathioprine, cyclophosphamide, cyclosporine, prednisone >15 mg daily or >30 mg every 2 days OR equivalent dose of other oral corticosteroids as well as any investigational drug within 4 weeks of visit 2;
    23. Treatment for pulmonary hypertension with prostaglandins (e.g., epoprostenol, treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan), phosphodiesterase inhibitors (e.g., sildenafil, tadalafil, vardenafil) or a stimulator of guanylatcyclase (e.g., riociguat) within 4 weeks of visit 2;
    24. Treatment with potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir within 4 weeks of visit 2;
    25. Supplementation with L-arginine and concurrent use of grapefruit juice or St John's wort within 4 weeks of visit 2;
    26. Treatment with the reduced dose of nintedanib (100 mg bid) within 4 weeks of visit 2;
    27. Permanent discontinuation of nintedanib in the past due to adverse events considered drug-related;
    28. Known hypersensitivity or intolerance to nintedanib, sildenafil, galactose, peanut or soya or any other components of the study medication;
    29. A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial;
    30. Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment;
    31. Women who are pregnant, nursing, or who plan to become pregnant while in the trial;
    31.Women who are pregnant, nursing, or who plan to become pregnant while in the trial;
    32.Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly;
    33.Patients not able to understand and follow study procedures including completion of self-administered questionnaires without help.
    1.Sélection antérieure dans cet essai ;
    2.ALT, AST > 1.5 fois la limite supérieure normale (ULN) à la visite V1;
    3.Bilirubine totale > 1.5 fois la limite supérieure normale (ULN) à la visite 1 ;
    4.Obstruction importante des voies respiratoires (FEV1/FVC <0.7 à la visite V1 avant la prise de bronchodilatateur) ;
    5.Antécédents d’infarctus du myocarde dans les 6 mois précédant la visite V1 ou d’angor instable dans le mois précédant la visite V1 ;
    6.Risques de saignement: prédisposition génétique connue aux hémorragies ; patients nécessitant une fibrinolyse, un traitement anticoagulant à pleine dose (par ex. Anti-vitamines K, dabigatran, héparine, hirudine, etc.) ou un traitement anti-agrégant plaquettaire à forte dose ; antécédents d’événement hémorragique du système nerveux central au cours des 12 mois précédant la visite V1 ; antécédents d’hémoptysie ou d’hématurie, d’hémorragie ou d’ulcères gastro-intestinaux actifs et/ou de lésion majeure ou d’intervention chirurgicale majeure au cours des 3 mois précédant la visite V1 ; ratio normalisé international (INR) > 2 à la visite V1 ; temps de prothrombine (PT) et le temps partiel de thromboplastine (PTT)> 150% de la limite supérieure normale institutionnelle à la visite V1 ;
    7.Chirurgie majeure prévue durant la participation à l'essai, y compris une transplantation pulmonaire, ou une chirurgie abdominale ou intestinale majeure ;
    8.Antécédents d'événement thrombotique (y compris accident vasculaire cérébral et accident ischémique transitoire) dans les 12 mois précédant la visite V1 ;
    9.Clairance de la créatinine < 30 mL/min calculée par la formule de Cockcroft–Gault à la visite V1 ;
    10.Présence d’une sténose aortique à la visite V1 ;
    11.Insuffisance cardiaque chronique importante : définie par une fraction d'éjection ventriculaire gauche (EF) <25% à la visite V1;
    12.Présence de sténose sous-aortique hypertrophique idiopathique (IHSS) selon le jugement de l'investigateur à la visite V 1;
    13.Bloc auriculo-ventriculaire à l’ECG de 2eme ou 3eme degré selon le jugement de l’investigateur à la V1 ;
    14.Hypotension (pression sanguine systolique [SBP] < 100 mm Hg ou pression sanguine diastolique [DBP] < 50 mm Hg) (hypotension orthostatique symptomatique) à la visite V1 ;
    15.Hypertension systémique non contrôlée (SBP > 180 mmHg; DBP > 100 mmHg) à la V1 ;
    16. Malformations du pénis connues ou des conditions (par exemple, l'anémie falciforme, le myélome multiple, la leucémie) pouvant prédisposer au priapisme;
    17.Rétinite pigmentaire;
    18.Antécédents de pertes de vue ;
    19.Antécédents de neuropathie optique ischémique non artéritique ;
    20.Maladie veino-occlusive ;
    21.Antécédents d’exacerbation aigue de la FPI ou infection respiratoire dans les 8 semaines précédant la visite V2 ;
    22.Traitement par les nitrates, la n-acétylcystéine, la pirfenidone, azathioprine, cyclophosphamide, cyclosporine, prednisone>15 mg par jour ou > 30 mg tous les 2 jours OU par une dose équivalente d’autres corticoïdes oraux ainsi que tout autre traitement expérimental au cours des quatre semaines précédant la visite 2 ;
    23.Traitement de l’hypertension pulmonaire par les prostaglandines (exemple, epoprosténole, tréprostinil), antagonistes de l’endotheline-1 (ex. sildénafil, tadalafil, vardénafil) ou un simulateur de guanylatcyclase (ex. riociguat) dans les quatre semaines précédant la visite V2 ;
    24.Traitement par les inhibiteurs puissants de cytochrome P450 3A4 (CYP3A4) tels que le ketoconazole, l’itraconazole et le ritonavir dans les quatre semaines précédant la visite V4 ;
    25.Supplémentation avec la L-arginine et utilisation concomitante du jus de pamplemousse ou de feuilles de millepertuis perforées dans les quatre semaines précédant la visite V2 ;
    26.Traitement à dose réduite du nintedanib (100 mg bid) dans les 4 semaines précédant la visite V2 ;
    27.Arrêt définitif de la prise du nintedanib dans le passé en raison d’intolérance ou événements indésirables considérés comme liés au traitement ;
    28.Hypersensibilité connue au nintedanib, cacahuète, soja, ou tout autre composant des médicaments de l’étude ;
    29.Maladie ou état qui, selon l’investigateur, est susceptible d’interférer avec les procédures de l’étude ou d’exposer le patient à un risque du fait de sa participation à l’étude ;
    30.Alcoolisme ou toxicomanie en cours, selon le jugement de l’investigateur.
    31.Femmes enceintes ou allaitantes ou qui prévoient d’être enceinte pendant l’étude ;
    32.Femme en âge de procréer n’ayant pas accès aux méthodes de contraception efficaces selon les ICH M3 présentant un taux d’échec de moins de 1% par an lorsqu’elles sont utilisées constamment et correctement
    33.Patients incapables de comprendre et de respecter les procédures de l’étude, y compris de répondre sans aide aux auto-questionnaires ;
    34.Patients atteints de maladies hépatiques chroniques sous-jacentes (Child Pugh A, B ou C) ;
    E.5 End points
    E.5.1Primary end point(s)
    1: change from baseline in SGRQ total score at week 12
    1:Changement du score total du questionnaire SGRQ à la semaine 12 par rapport au score initial obtenu à V2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: week 12
    1: semaine 12
    E.5.2Secondary end point(s)
    1: change from baseline in UCSD SOBQ at week 12

    2: change from baseline in SGRQ total score at week 24

    3: change from baseline in UCSD SOBQ at week 24

    4: % of patients with on-treatment SAE from baseline to week 24
    1: Changement du score UCSD SOBQ à la semaine 12 par rapport au score initial obtenu à V2
    2: Changement du score SGRQ à la semaine 24 par rapport au score initial obtenu à la V2
    3: changement du score UCSD SOBQ à la semaine 24 par rapport au score initial obtenu à V2
    4: Pourcentage des patients présentant des EIGs sous traitement de la V2 jusqu’à la semaine 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: week 12

    2: week 24

    3: week 24

    4:week 24
    1: semaine 12

    2: semaine 24

    3: semaine 24

    4: semaine 24
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarqueurs
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    China
    France
    Germany
    India
    Italy
    Japan
    Korea, Republic of
    Mexico
    Spain
    United Kingdom
    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
    LVLS
    LVLS: dernière visite du dernier patient
    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 months10
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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 clinical practice
    Les patients seront traités selon la pratique clinique
    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 Decision2017-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-13
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