Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2015-002619-14

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

1199.36

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Boehringer Ingelheim France
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Boehringer Ingelheim
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim
B.5.2	Functional name of contact point	QRPE PSC CT Information Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+18002430127
B.5.5	Fax number	+18008217119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ofev
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/13/1123
D.3 Description of the IMP
D.3.1	Product name	Ofev 100 mg capsule
D.3.2	Product code	nintedanib
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	nintedanib
D.3.9.1	CAS number	656247-17-5
D.3.9.3	Other descriptive name	NINTEDANIB
D.3.9.4	EV Substance Code	SUB120728
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ofev
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/13/1123
D.3 Description of the IMP
D.3.1	Product name	Ofev 150 mg capsule
D.3.2	Product code	nintedanib
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	nintedanib
D.3.9.1	CAS number	656247-17-5
D.3.9.3	Other descriptive name	NINTEDANIB
D.3.9.4	EV Substance Code	SUB120728
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Revatio
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Revatio 20 mg
D.3.2	Product code	sildenafil
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SILDENAFIL
D.3.9.1	CAS number	139755-83-2
D.3.9.3	Other descriptive name	sildenafil
D.3.9.4	EV Substance Code	SUB10517MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical 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.1.1.1

Medical condition in easily understood language

Idiopathic pulmonary fibrosis

Fibrose pulmonaire idiopathique

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10021240
E.1.2	Term	Idiopathic pulmonary fibrosis
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

1: week 12

1: semaine 12

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biomarkers

Biomarqueurs

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If 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.8.7

Trial 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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-04-13

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Select Trial Status:	Select Trial Phase:
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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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