Clinical Trials Register

Summary
EudraCT Number:	2012-003346-32
Sponsor's Protocol Code Number:	CQVA149A2336
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:	2013-01-09
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

2012-003346-32

A.3

Full title of the trial

A 12-week treatment, multi-center, randomized, double-blind, parallel group, placebo and active controlled study to assess the efficacy, safety, and tolerability of QVA149 (indacaterol maleate /glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation

Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y tratamiento activo de 12 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de QVA149 (maleato de indacaterol / bromuro de glicopirronio) en pacientes con EPOC con una limitación del flujo aéreo de moderada a grave.

A.3.1

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

A multi-centre randomized double blind 12-week study to assess the efficacy, safety and tolerability of QVA149 in patients with COPD who have moderate to severe airflow limitation

Estudio multicéntrico, aleatorizado, doble ciego, de 12 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de QVA149 en pacientes con EPOC con una limitación del flujo aéreo de moderada a grave.

A.4.1

Sponsor's protocol code number

CQVA149A2336

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	Novartis Farmacéutica, S.A.
B.1.3.4	Country	Spain
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	Novartis Pharma Service AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farmacéutica, S.A.
B.5.2	Functional name of contact point	Departamento Médico (ICRO)
B.5.3	Address:
B.5.3.1	Street Address	Gran Via de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034900353036
B.5.5	Fax number	0034932479903
B.5.6	E-mail	eecc.novartis@novartis.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	No
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	Indacaterol maleate/Glycopyrronium bromide
D.3.2	Product code	QVA149
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
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	GLYCOPYRRONIUM BROMIDE
D.3.9.1	CAS number	596-51-0
D.3.9.2	Current sponsor code	NVA237
D.3.9.4	EV Substance Code	SUB07951MIG
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	12.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INDACATEROL
D.3.9.1	CAS number	753498-25-8
D.3.9.2	Current sponsor code	QAB149
D.3.9.4	EV Substance Code	SUB30300
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	27.5
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	Yes
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	No
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	Indacaterol
D.3.2	Product code	QAB149
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
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	INDACATEROL
D.3.9.1	CAS number	753498-25-8
D.3.9.2	Current sponsor code	QAB149
D.3.9.4	EV Substance Code	SUB30300
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	27.5
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	Yes
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	No
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	Glycopyrronium bromide
D.3.2	Product code	NVA237
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
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	GLYCOPYRRONIUM BROMIDE
D.3.9.1	CAS number	596-51-0
D.3.9.2	Current sponsor code	NVA237
D.3.9.4	EV Substance Code	SUB07951MIG
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	12.5
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	Yes
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	Inhalation powder, hard capsule
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

Chronic Obstructive Pulmonary Disease (COPD)

Enfermedad Pulmonar Obstructiva Crónica (EPOC)

E.1.1.1

Medical condition in easily understood language

COPD is a chronic condition of the lungs which causes people to suffer symptoms such as shortness of breath and coughing.

La EPOC es una enfermedad crónica de los pulmones que causa síntomas como dificultad para respirar y tos.

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	15.1
E.1.2	Level	LLT
E.1.2	Classification code	10010952
E.1.2	Term	COPD
E.1.2	System Organ Class	100000004855

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 demonstrate the superiority of QVA149 27.5/12.5 ?g b.i.d. compared to monotherapy components, QAB149 27.5 ?g b.i.d. and NVA237 12.5 ?g b.i.d., in terms of standardized FEV1AUC0-12 at Week 12.

Demostrar la superioridad de QVA149 27,5/12,5 µg b.i.d. en comparación con los componentes en monoterapia QAB149 27,5 µg b.i.d. y NVA237 12,5 µg b.i.d. en cuanto a AUC0-12 del FEV1 estandarizada en la semana 12.

E.2.2

Secondary objectives of the trial

Key secondary objective: To demonstrate the superiority of QVA149 27.5/12.5 ?g b.i.d. compared to placebo at Week12 in terms of the change in Health Status, based on total score as well as the percentage of patients with clinically significant improvement, as reported by the patients using the SGRQ.
Secondary objectives
- To evaluate the superiority of QVA149 27.5/12.5 ?g b.i.d., QAB149 27.5 ?g b.i.d. and NVA237 12.5 ?g b.i.d. compared to placebo in terms of standardized FEV1AUC0-12 at Wk 12.
- To evaluate the superiority of QVA149 27.5/12.5 ?g b.i.d., QAB149 27.5 ?g b.i.d. and NVA237 12.5 ?g b.i.d. compared to placebo in terms of the following endpoints:
-trough FEV1 (mean of 23 h 15 min and 23 h 45 min post morning dose) at Wk 12
-pre-dose trough FEV1 (mean of 15 min and 45 min pre morning dose) at Week 12
-Trough FEV1 (mean of 23 h 15 min and 23 h 45 min post morning dose) after Day1
-FEV1 and FVC at any time point
Other secondary objectives listed in the protocol may apply

1. Evaluar la superioridad de QVA149 27,5/12,5 µg b.i.d., QAB149 27,5 µg b.i.d. y NVA237 12,5 µg b.i.d. en comparación con placebo en cuanto a AUC0-12 del FEV1 estandarizada en la semana 12.
2. Evaluar la superioridad de QVA149 27,5/12,5 µg b.i.d., QAB149 27,5 µg b.i.d. y NVA237 12,5 µg b.i.d. en comparación con placebo en cuanto a las siguientes variables en la semana 12.
? FEV1 valle (media de 23 h 15 min y 23 h 45 min tras la dosis matutina).
? FEV1 valle predosis (media de 15 min y 45 min antes de la dosis matutina).
3. Evaluar la superioridad de QVA149 27,5/12,5 µg b.i.d. en comparación con placebo en la semana 12 en cuanto a:
? Nivel de dificultad para respirar experimentada por los pacientes evaluado mediante el índice de transición de disnea (TDI)
? La medicación de rescate utilizada (número de inhalaciones) que ha indicado el paciente en el diario electrónico del paciente
? Síntomas notificados en el diario electrónico
Referirse al protocolo para ver resto de objetivos

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients who have signed an Informed Consent Form prior to initiation of any studyrelated
procedure.
2. Male and female adults aged ?40 years.
3. Patients with stable COPD according to the current GOLD strategy.
4. Patients with airflow limitation indicated by a post-bronchodilator FEV1 ? 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101). Post-bronchodilator refers to 1 hour after sequential inhalation of 84 ?g ipratropium bromide (or equivalent dose) and 400 ?g salbutamol (or 360 ?g albuterol). Spacer devices are not permitted during reversibility testing.
5. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g.10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker may be defined as a subject who has not smoked for ? 6 months at screening.
6. Patients with an mMRC grade 2 or greater at Visit 101.

1. Pacientes que hayan firmado el formulario de consentimiento informado antes de iniciar cualquier procedimiento relacionado con el estudio.
2. Personas adultas de ambos sexos de edad ? 40 años.
3. Pacientes con EPOC estable conforme a la estrategia GOLD actual (GOLD, 2011).
4. Pacientes con una limitación del flujo aéreo indicada mediante un FEV1 postbroncodilatador ? 30% y < 80% del valor teórico y un FEV1/CVF postbroncodilatador < 0,70 en la preinclusión (visita 101).
Postbroncodilatador se refiere a 1 hora después de la inhalación secuencial de 84 µg de bromuro de ipratropio (o dosis equivalente) y 400 µg de salbutamol. No se permite el uso de espaciadores durante las pruebas de reversibilidad.
5. Fumadores actuales o ex fumadores que tengan antecedentes de tabaquismo de al menos 10 paquetes año (p. ej., 10 paquetes año = 1 paquete /día x 10 años o ½ paquete/día x 20 años). Un ex fumador puede definirse como un sujeto que no ha fumado durante un periodo ? 6 meses en la visita de selección.
6. Pacientes con un grado 2 o superior según el mMRC en la visita 101 (véase el apartado 6.6.1).

E.4

Principal exclusion criteria

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test.
2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods are described in the protocol3. Patients with Type I or uncontrolled Type II diabetes.
3. Patients with Type I or uncontrolled Type II diabetes.
4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened.
5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened)
6. Patients who have a clinically significant laboratory abnormality at Visit 101.
7. Patients with a body mass index (BMI) of more than 40 kg/m2.
8. Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment.
9. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at Visit 101 and Visit 102 visits with a resting ventricular rate < 100/min. At Visit 101 the atrial fibrillation must be confirmed by central reading.
10. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
? anticholinergic agents
? long and short acting beta-2 agonists
? sympathomimetic amines
? lactose or any of the other excipients of trial medication

For the full list of exclusion criteria, please refer to the protocol.

Los pacientes que cumplan alguno de los siguientes criterios no son elegibles para participar en este estudio. El investigador no podrá aplicar ningún otro criterio de exclusión adicional para garantizar que la población del estudio sea representativa de todos los pacientes elegibles.
1. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta que finalice la gestación, confirmado por un resultado positivo en la analítica de hCG (gonadotropina coriónica humana).
2. Mujeres en edad fértil, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, salvo que estén utilizando métodos anticonceptivos efectivos durante la administración del tratamiento del estudio. Los métodos anticonceptivos están descritos en el protocolo.
3. Pacientes con diabetes tipo I o tipo II no controlada.
4. Pacientes con antecedentes de síndrome QT largo, o cuyo intervalo QTc medido en la visita 101 (método de Fridericia) sea prolongado (> 450 ms para hombres y mujeres) y que esté confirmado por un asesor central. Estos pacientes no volverán a ser seleccionados.
5. Pacientes que presenten una anomalía en el ECG clínicamente significativa en la visita 101 o en la visita 102. (Estos pacientes no volverán a ser seleccionados).
6. Pacientes que presenten una anomalía clínicamente significativa en las pruebas analíticas de la visita 101.
7. Pacientes con un índice de masa corporal (IMC) superior a 40 kg/m2.
8. Pacientes que presenten una anomalía renal, cardiovascular (cardiopatía isquémica inestable, insuficiencia ventricular izquierda de clase III/IV de la NYHA, infarto de miocardio, entre otros), arritmia (a continuación encontrará información para los pacientes con fibrilación auricular), neurológica, endocrina, inmunológica, psiquiátrica, gastrointestinal, hepática o hematológica clínicamente significativa que pudiera interferir en la evaluación de eficacia y seguridad del tratamiento del estudio.
9. Quedan excluidos los pacientes con fibrilación auricular paroxística (p. ej., intermitente). Los pacientes que presenten una fibrilación auricular persistente definida como una fibrilación auricular continua durante al menos 6 meses y controlada mediante una estrategia de control de velocidad (es decir, betabloqueante selectivo, bloqueante de los canales de calcio, implantación de un marcapasos, terapia de ablación o con digoxina) durante al menos 6 meses se pueden incluir en el estudio. Estos pacientes deben presentar una fibrilación auricular en la visita 101 y visita 102 con una frecuencia ventricular en reposo < 100/min. En la visita 101 la fibrilación auricular debe confirmarse mediante una lectura central.
10. Pacientes con contraindicación para el tratamiento con cualquiera de los siguientes fármacos inhalados o fármacos de clase similar o cualquiera de sus componentes, o que tengan antecedentes de reacciones/hipersensibilidad a dichos fármacos o a cualquiera de sus componentes:
? Anticolinérgicos
? Agonistas beta 2 de acción corta y prolongada
? Aminas simpaticomiméticas
? Lactosa o cualquier otro excipiente de la medicación del ensayo
Referirse al protocolo para ver el resto de criterios.

E.5 End points

E.5.1

Primary end point(s)

Standardized Forced Expiratory Volume in one second Area Under the Curve (AUC) following 12 weeks of treatment.

La variable de eficacia principal es AUC0-12 del FEV1 en la semana 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

Timeframe : 12 weeks

Periodo: 12 semanas

E.5.2

Secondary end point(s)

1-Total St. George's Respiratory Questionnaire score
2-Trough Forced Expiratory Volume in one second
3-Pre-dose trough Forced Expiratory Volume in one second
4-Transitional Dyspnea Index focal score
5-Number of puffs of rescue medication
6-Daily symptoms score
7-Trough Forced Expiratory Volume in one second
8-Forced Expiratory Volume in one second at any time point
9-Morning symptoms score
10-Evening symptoms scores
11-Forced Vital Capacity at different time points

1-Puntuación total del SGRQ en la semana 12
2-Volumen Expiratorio Formazado en el primer segundo
3-Volumen Expiratorio Formazado en el primer segundo, pre dosis
4-Puntuación en el Indice de Transición de Disnea Focal
5-Numbero de inhalaciones de medicación de rescate
6-Puntuación de los sintomas diarios
7-Volumen Expiratorio Formazado en el primer segundo
8-Volumen Expiratorio Formazado en el primer segundo, en los tiempos
9-Puntuación de los síntomas de la mañana
10-Puntuación de los síntomas de la noche
11-Capacidad Vital Forzada en los tiempos.

E.5.2.1

Timepoint(s) of evaluation of this end point

Timeframe :
1.2.3.4.5.6.7.9.10.11 : 12 weeks
8 : day 1

Tiempos:
1.2.3.4.5.6.7.9.10.11 : 12 semanas
8 : dia 1

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

Yes

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

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

Canada

Philippines

Poland

Romania

Spain

Ukraine

United States

Vietnam

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

170

F.4.2.2

In the whole clinical trial

1000

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 completing the 12 week treatment period will not be given further access to study
drug because the risk benefit ratio will not have been substantiated by that time and there are
already other marketed therapeutic alternatives available to treat these patients. At the time of
study completion or early termination, the investigator must provide follow-up medical care
or must refer them for appropriate ongoing care.

Los pacientes que finalicen el periodo de 12 semanas de tratamiento no tendrán acceso al fármaco del estudio debido a que por el momento no se ha confirmado la relación beneficio/riesgo y existen otras alternativas terapéuticas comercializadas para tratar a esos pacientes. En el momento de la finalización del estudio o finalización prematura, el investigador debe proporcionar asistencia médica de seguimiento o deberá remitirlos para que reciban el cuidado adecuado.

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

2013-02-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-05

P. End of Trial
P.	End of Trial Status	Completed

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