Clinical Trials Register

Summary
EudraCT Number:	2014-000593-19
Sponsor's Protocol Code Number:	D589UC00001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-08-06
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

Spain - AEMPS

A.2

EudraCT number

2014-000593-19

A.3

Full title of the trial

A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® pMDI 160/4.5 µg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 µg x 2 Inhalations Twice-daily in COPD Patients
The RISE study: Revealing the Impact of Symbicort in reducing Exacerbations in COPD

Ensayo Fase IIIB, doble ciego, con doble enmascaramiento, aleatorizado, de grupos paralelos, multicéntrico, de 6 meses de tratamiento con Symbicort® pMDI 160/4,5µg x 2 aplicaciones dos veces al día en comparación con Formoterol Turbuhaler 4,5 µg x 2 inhalaciones dos veces al día, sobre las Exacerbaciones en pacientes con EPOC"
RISE: Revelando el Impacto de Symbicort en la reducción de las exarcebaciones en EPOC

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients suffering from Cronic Obstructive Pulmonary Disease.

Comparar la eficacia en cuanto a reducción de las exacerbaciones de Symbicort pMDI frente a formoterol Turbuhaler en pacientes con Enfermedad Pulmonar Obstructiva Crónica.

A.3.2

Name or abbreviated title of the trial where available

The RISE study: Revealing the Impact of Symbicort in reducing Exacerbations in COPD

RISE: Revelando el Impacto de Symbicort en la reducción de las exarcebaciones en EPOC

A.4.1

Sponsor's protocol code number

D589UC00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Farmacéutica Spain, S.A.
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/ Serrano Galvache, 56; Parque Norte, Edificio Roble
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034900200444
B.5.6	E-mail	informacionEECC-Spain@astrazeneca.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	Vannair
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AG
D.2.1.2	Country which granted the Marketing Authorisation	Switzerland
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	SYMBICORT pMDI 160/4.5
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Budesonide
D.3.9.1	CAS number	51333-22-3
D.3.9.3	Other descriptive name	BUDESONIDE
D.3.9.4	EV Substance Code	SUB05955MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE
D.3.9.4	EV Substance Code	SUB02257MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.5
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	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	Oxis
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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	Formoterol Turbuhaler
D.3.4	Pharmaceutical form	Inhalation powder
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE
D.3.9.4	EV Substance Code	SUB02257MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.5
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	Pressurised inhalation
D.8.4	Route of administration of the placebo	Inhalation use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation powder
D.8.4	Route of administration of the placebo	Inhalation 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 moderate to very severe chronic obstructive pulmonary disease (COPD)

Pacientes con enfermedad pulmonar obstructiva crónica (EPOC) de moderada a muy grave

E.1.1.1

Medical condition in easily understood language

Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible.

Enf. pulmonar obstructiva crónica (EPOC) es una enf. pulmonar caracterizada por la obstrucción crónica del flujo de aire al pulmón que interfiere con la respiración normal y no es del todo reversible

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy in reducing exacerbations with Symbicort pMDI 160/4.5 µg x 2 actuations BID versus formoterol Turbuhaler 4.5 µg x 2 inhalations BID in COPD subjects

Comparar la eficacia en cuanto a reducción de las exacerbaciones con Symbicort pMDI 160/4,5 µg x 2 aplicaciones BID frente a formoterol Turbuhaler 4,5 µg x 2 inhalaciones BID en pacientes con EPOC

E.2.2

Secondary objectives of the trial

To compare Symbicort pMDI and formoterol Turbuhaler treatments on the time to the first COPD exacerbation
To compare Symbicort pMDI and formoterol Turbuhaler treatments on health status/health-related quality of life
To compare Symbicort pMDI and formoterol Turbuhaler treatments on pulmonary function
To compare Symbicort pMDI and formoterol Turbuhaler treatments on rescue medication use
To compare Symbicort pMDI and formoterol Turbuhaler treatments on nocturnal awakenings
To demonstrate the safety of Symbicort pMDI compared to that of formoterol Turbuhaler in subjects with COPD

Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto al tiempo hasta la primera exacerbación de la EPOC
Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto al estado de salud/la calidad de vida relacionada con la salud
Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto a la función pulmonar
Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto al uso de medicación de rescate
Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto a los despertares nocturnos
Demostrar la seguridad de Symbicort pMDI en comparación con la de formoterol Turbuhaler en pacientes con EPOC

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed Informed Consent at Visit 1 obtained prior to conducting any study-related procedures including withdrawal of medications.
2. Outpatients; men or women ? 40 years of age.
3. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines.
4. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year).
5. Post-bronchodilator FEV1/forced vital capacity (FVC) <0.7 (70%) and FEV1 ? 70% of predicted normal (PN) value.
6. Documented use of a short-acting inhaled bronchodilator (?2-agonists or anticholinergics) as rescue medication within 6 months prior to study start.
7. A score of ? 2 on the modified medical research council (MMRC) dyspnea scale.
8. Documented history of ?1 moderate or severe COPD exacerbation(s) that required treatment with systemic (oral, IM, IV) corticosteroids (a minimum 3 day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or >24 hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2-52 weeks before Visit 1 (i.e., not within the 14 days prior to Visit 1). A history of an exacerbation treated exclusively with antibiotics will not be considered adequate.

1. Firma del consentimiento informado en la visita 1, obtenido antes de realizar ningún procedimiento relacionado con el ensayo, incluida la retirada de medicamentos.
2. Pacientes ambulatorios; varones o mujeres ? 40 años.
3. Diagnóstico clínico actual de EPOC con síntomas de EPOC durante más de 1 año, de acuerdo con las directrices GOLD.
4. Tabaquismo actual o previo con antecedentes de tabaquismo equivalentes a 10 paquetes-año o más (1 paquete-año = 20 cigarrillos fumados al día durante 1 año).
5. FEV1/capacidad vital forzada (FVC) post-broncodilatador <0,7 (70%) y FEV1 ? 70% del valor normal predictivo (NP) post-broncodilatador.
6. Uso documentado de un broncodilatador inhalado de acción corta (?2-agonistas o anticolinérgicos) como medicación de rescate dentro de los 6 meses previos al comienzo del ensayo.
7. Una puntuación ? 2 en la escala de disnea Medical Research Council modificada (MRCm).
8. Antecedentes documentados de ?1 exacerbación moderada o grave de EPOC que precisó tratamiento con corticosteroides sistémicos (oral, IM, IV) (un ciclo mínimo de 3 días de un tratamiento con corticosteroides orales o una única inyección de corticosteroides depot) u hospitalización (definida como una estancia hospitalaria o una estancia >24 horas en un área de observación en un servicio de urgencias o una instalación equivalente dependiendo del país y del sistema sanitario) en el plazo entre 2 y 52 semanas antes de la visita 1 (esto es, no dentro de los 14 días previos a la visita 1). Los antecedentes de una exacerbación tratada exclusivamente con antibióticos no se considerarán suficientes.

E.4

Principal exclusion criteria

1. A history of asthma at or after 18 years of age.
2. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator.
3. Known homozygous alpha-1 antitrypsin deficiency.
4. Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject?s ability to participate in the study.
5. A history of malignancy (except basal cell carcinoma) within the past 5 years.
6. Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases.
7. Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 14 days prior to Visit 1 and up to Visit 3.
8. CXR (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment, or put the subject at risk because of participation in the study.
9. Risk factors for pneumonia: immune suppression (HIV, lupus) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson?s disease, myasthenia gravis, etc.).
10. Pneumonia not resolved within 14 days of Visit 1.
11. Moderate or severe COPD exacerbation that has not resolved within 14 days prior to Visit 1 or a moderate or severe COPD exacerbation that occurs between Visit 1 and Visit 2.
12. Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.

1. Antecedentes de asma a los 18 años de edad o después.
2. Pacientes con cardiopatía isquémica significativa o inestable, arritmia, miocardiopatía, insuficiencia cardíaca (incluido cor pulmonale significativo), hipertensión no controlada definida por el investigador o cualquier otro trastorno cardiovascular relevante a criterio del investigador.
3. Déficit homocigótico conocido de alfa-1 antitripsina.
4. Cualquier enfermedad o trastorno significativo (p. ej., gastrointestinal, hepático, renal, neurológico, musculoesquelético, endocrino, metabólico, maligno, psiquiátrico, deterioro físico importante) que, en opinión del investigador, podría poner al paciente en riesgo debido a la participación en el ensayo o influir en los resultados del ensayo o la capacidad del paciente para participar en el ensayo.
5. Antecedentes de tumor maligno (excepto carcinoma basocelular) dentro de los últimos 5 años.
6. Tuberculosis activa, cáncer de pulmón, bronquiectasias, sarcoidosis, fibrosis pulmonar, hipertensión pulmonar primaria, enfermedad pulmonar intersticial u otra enfermedad pulmonar activa.
7. Pacientes que hayan necesitado adiciones o modificaciones a su tratamiento habitual de mantenimiento o cambio en la formulación del tratamiento de rescate para la EPOC, debido a empeoramiento de los síntomas dentro de los 14 días previos a la visita 1 y hasta la visita 3.
8. RxT (frontal y lateral) con sospecha de neumonía u otro problema/anomalía que precisará investigación/tratamiento adicional, o pondrá al paciente en riesgo debido a la participación en el ensayo.
9. Factores de riesgo de neumonía: inmunosupresión (VIH, lupus) u otro riesgo de neumonía (p. ej., trastornos neurológicos que afectan al control de las vías aéreas superiores, como enfermedad de Parkinson, miastenia grave, etc.).
10. Neumonía no resuelta en el plazo de 14 días antes de la visita 1.
11. Exacerbación moderada o grave de la EPOC que no se ha resuelto en el plazo de 14 días antes de la visita 1 o exacerbación moderada o grave de la EPOC que se produce entre la visita 1 y la visita 2.
12. Oxigenoterapia a largo plazo (OTLP) u oxigenoterapia nocturna, necesarias durante más de 12 horas al día.

E.5 End points

E.5.1

Primary end point(s)

The rate of moderate and severe COPD exacerbations defined as:
Worsening of ?2 major symptoms or worsening of 1 major symptom together with ?1 minor symptom for ?2 consecutive days.
Moderate exacerbation: treatment of symptoms with systemic corticosteroids (?3 days) and/or antibiotics.
Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting).
Major symptoms:
- Dyspnea
- Increase in sputum volume
- Increase in sputum color/purulence
Minor symptoms:
- Sore throat
- Colds (nasal discharge and/or nasal congestion)
- Fever without other cause
- Increased cough
- Increased wheeze

Tasa de exacerbación moderada y grave de EPOC definida como:
Empeoramiento de ? 2 síntomas mayores o empeoramiento de 1 síntoma mayor junto con ? 1 síntoma menor durante ? 2 días consecutivos.
Exacerbación moderada: tratamiento de síntomas con corticosteroides sistémicos (?3 días) y/o antibióticos.
Exacerbación grave: síntomas que precisan hospitalización (incluidas >24 horas en un servicio de urgencias).
Síntomas mayores:
- Disnea
- Aumento del volumen de esputo
- Aumento del color/la purulencia del esputo
Síntomas menores:
- Dolor de garganta
- Resfriados (secreción nasal y/o congestión nasal)
- Fiebre sin otra causa
- Aumento de la tos
- Aumento de las sibilancias

E.5.1.1

Timepoint(s) of evaluation of this end point

Study Visit:
Enrolment W -5
Run-in W -4
Randomization W 0
Treatment W 4, 8, 17
EoT W 26

Visitas del estudio:
Reclutamiento: Semana -5
Preinclusión: Semana -4
Aleatorización: Semana 0
Tratamiento: Semana 4, 8, 17
FdT: Semana 26

E.5.2

Secondary end point(s)

- Time to first moderate or severe COPD exacerbation
- St. George´s Respiratory Questionnaire (SGRQ)
- Pre-dose/pre-bronchodilator FEV1 at the study site
- Total rescue medication use (average puffs/day)
- Nights with awakening due to COPD

- Tiempo hasta la primera exacerbación moderada o grave de la EPOC
- Cuestionario respiratorio de St. George (SGRQ)
- Volumen espiratorio forzado en un segundo (FEV1) pre-dosis/pre-broncodilatador en el centro del ensayo
- Utilización total de medicamentos de rescate (media de inhalaciones/día)
- Noches con despertares debidos a EPOC

E.5.2.1

Timepoint(s) of evaluation of this end point

Study Visit:
Enrolment W -5
Run-in W -4
Randomization W 0
Treatment W 4, 8, 17
EoT W 26

Visitas del estudio:
Reclutamiento: Semana -5
Preinclusión: Semana -4
Aleatorización: Semana 0
Tratamiento: Semana 4, 8, 17
FdT: Semana 26

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

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

Yes

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

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

Argentina

Bulgaria

Chile

Czech Republic

European Union

Mexico

Poland

South Africa

Spain

United States

E.8.7

Trial has a data monitoring committee

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

Última visita del último paciente

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.1.1.1

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:

1136

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1136

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

353

F.4.2.2

In the whole clinical trial

1136

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
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-10-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-02-10

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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