Clinical Trials Register

Summary
EudraCT Number:	2012-003292-19
Sponsor's Protocol Code Number:	EFC12703
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:	2013-04-09
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

2012-003292-19

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter, 24 week study assessing the safety and efficacy of lixisenatide in older patients with type 2 diabetes inadequately controlled on their current diabetes treatment regimen

Estudio de 24 semanas de duración, multicéntrico, de 2 brazos paralelos, controlado con placebo, doble ciego y aleatorizado que evalúa la eficacia y seguridad de lixisenatida en pacientes ancianos con diabetes tipo 2 inadecuadamente controlada con su régimen de tratamiento actual para la diabetes.

A.3.1

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

Efficacy and safety of lixisenatide versus placebo on top of basal insulin and/or oral antidiabetic treatment in older type 2 diabetic patients

Eficacia y seguridad de lixisenatida versus placebo añadido al tratamiento de insulina basal y/o antidiabéticos orales en pacientes ancianos con diabetes tipo 2

A.3.2

Name or abbreviated title of the trial where available

GetGoal-O

A.4.1

Sponsor's protocol code number

EFC12703

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	Sanofi-Aventis Recherche & Développement
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	Sanofi-Aventis Recherche et Développement
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	sanofi-aventis, s.a.
B.5.2	Functional name of contact point	CSU Director, Dra. Bibiana Figueres
B.5.3	Address:
B.5.3.1	Street Address	c/ Josep Pla nº2, 5ª planta
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08019
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34 93 485 94 66
B.5.5	Fax number	+34 93 489 54 66
B.5.6	E-mail	bibiana.figueres@sanofi.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	Lyxumia 10 micrograms solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	sanofi-aventis groupe
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	lixisenatide
D.3.2	Product code	AVE0010
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lixisenatide
D.3.9.1	CAS number	320367-13-3
D.3.9.2	Current sponsor code	AVE0010
D.3.9.3	Other descriptive name	LIXISENATIDE
D.3.9.4	EV Substance Code	SUB32251
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Lyxumia 20 micrograms solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	sanofi-aventis groupe
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	lixisenatide
D.3.2	Product code	AVE0010
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lixisenatide
D.3.9.1	CAS number	320367-13-3
D.3.9.2	Current sponsor code	AVE0010
D.3.9.3	Other descriptive name	LIXISENATIDE
D.3.9.4	EV Substance Code	SUB32251
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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.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	Solution for injection in pre-filled pen
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 2 Diabetes mellitus

Diabetes Mellitus tipo 2

E.1.1.1

Medical condition in easily understood language

Type 2 Diabetes

Diabetes tipo 2

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

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 evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by HbA1c reduction, in older type 2 diabetes patients (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen

Evaluar el efecto de lixisenatida con respecto a placebo durante 24 semanas sobre el control glucémico, evaluado mediante reducción de la HbA1c, en pacientes mayores con diabetes mellitus tipo 2 (DMT2) inadequadamente controlada con su régimen de tratamiento antidiabético actual

E.2.2

Secondary objectives of the trial

Main secondary objective:
To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM patients (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects).
Other secondary objectives:
To assess the effect of lixisenatide compared to placebo after 24-week treatment on:
Fasting plasma glucose (FPG)
During liquid standardized breakfast meal challenge test : 2 hour- PPG and Plasma Glucose Excursion
7-point Self-monitored plasma glucose (SMPG) profile
Body weight
Change in total daily dose of basal insulin (if taken)
Percentage of patients requiring rescue therapy
Safety and tolerability
To assess lixisenatide pharmacokinetic profile
To assess anti-lixisenatide antibody development.

Objetivo secundario principal
Evaluar la seguridad y tolerabilidad de lixisenatida con respecto a placebo en pacientes mayores con DMT2 (incluida la aparición de hipoglucemia sintomática [glucosa plasmática GP <60 mg/dl] y efectos secundarios gastrointestinales documentados).
Otros objetivos secundarios:
Evaluar el efecto de lixisenatida con respecto a placebo después del tratamiento de 24 semanas con:
Glucosa plasmática en ayunas (GPA)
Durante la prueba de tolerancia al desayuno líquido estandarizado: Glucosa post-prandial (GPP) a las 2 horas y oscilación de la glucosa plasmática
El perfil de autocontrol de la glucosa plasmática (Self-monitored plasma glucose, SMPG) de 7 puntos
El peso corporal
El cambio en la dosis diaria total de insulina basal (si se toma)
El porcentaje de pacientes que requieren terapia de rescate
Seguridad y tolerabilidad
Evaluar el perfil farmacocinético (FC) de lixisenatida
Evaluar el desarrollo de anticuerpos antilixisenatida

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Older patients, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic regimen
? Signed written informed consent

Pacientes mayores, de más de 70 años de edad, con una DMT2 no controlada con su régimen antidiabético actual.
Consentimiento informado por escrito firmado

E.4

Principal exclusion criteria

? At screening HbA1c ?7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older patients and that this is the responsibility of the investigator to include the patient based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia)
? At screening patients on both basal insulin and sulfonylurea or basal insulin and meglitinides
? At screening FPG >250 mg/dL (>13.9 mmol/L)
? Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit.
? Type 2 diabetes mellitus diagnosed less than 1 year prior to screening
? Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening
? Treatment within the 3 months preceding the screening with other antidiabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea [except glibenclamide >10mg, glicazide >160mg], meglitinides [except repaglinide >6mg], pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population. .
? Patients who have been on an approved or an investigational GLP-1 medication (exenatide, liraglutide, lixisenatide or others)
? History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening
? BMI <22 or >40 kg/m²
? Malnutrition assessed clinically by the investigator or any sub-investigator and by MNA-SF score <12 in countries (the judgment of the investigator prevails on questionnaires scores)
? Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by MMSE score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that will affect the patient?s ability to participate in the study
? Patient who have an eGFR (using the Modification of Diet in Renal Disease {MDRD} formula <30ml/min/1.73m2
? Patients with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment
? Laboratory findings at the time of screening:
- Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range
- ALT or AST >3 times ULN
- Calcitonin >20 pg/mL (5.9 pmol/L)
? Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) and not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening
? History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
? Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposes to medullary thyroid cancer (eg, multiple endocrine neoplasia syndromes)

? En la selección, una HbA1c ?7,0 % o >10 % (reconociendo que el umbral del 7 % puede no ser apropiado para todos los pacientes mayores y que es responsabilidad del investigador incluir al paciente según una evaluación individual de los beneficios previstos de un mejor control de la glucemia en comparación con el riesgo de hipoglucemia [consultar la Sección 4.1.4])
? En la selección, pacientes con insulina basal y sulfonilurea o insulina basal y meglitinidas
? En la selección, GPA >250 mg/dl (>13,9 mmol/l)
? Diabetes mellitus tipo 1 o antecedentes de cetoacidosis en el plazo de un año antes de la visita de selección.
? Diabetes mellitus tipo 2 diagnosticada menos de 1 año antes de la selección
? Tratamiento antidiabético sin régimen estable o iniciado en el plazo de los últimos 3 meses antes de la selección
? Tratamiento en los 3 meses antes de la selección con otro agente antidiabético distinto de la terapia de base permitida. La terapia permitida para la diabetes incluye metformina, sulfonilurea (excepto glibenclamida >10 mg, glicazida >160 mg), meglitinidas (excepto repaglinida >6 mg), pioglitazona e insulina basal y se deben seguir las restricciones de las fichas técnicas y etiquetados locales del producto para la población del estudio.
? Pacientes que han recibido un medicamento de GLP-1 aprobado o en investigación (exenatida, liraglutida, lixisenatida u otros)
? Antecedentes de hipoglucemia severa asociada a inadvertencia de síntomas o que haya causado la pérdida del conocimiento/coma/convulsión en los 6 meses previos a la selección
? IMC <22 o >40 kg/m²
? Desnutrición evaluada clínicamente por el investigador o un subinvestigador y según una puntuación de MNA-SF <12 (el criterio del investigador prevalece sobre las puntuaciones de los cuestionarios)
? Trastorno cognitivo y demencia evaluados clínicamente por el investigador o un subinvestigador, y según la puntuación de MMSE <24 (el criterio del investigador prevalece sobre las puntuaciones de los cuestionarios) o cualquier trastorno neurológico que afecte la capacidad del paciente para participar en el estudio
? Pacientes que tienen una TFGe (utilizando la fórmula de modificación de la dieta en enfermedad renal [Modification of Diet in Renal Disease ,MDRD]) <30 ml/min/1,73 m2
? Pacientes con enfermedad grave o no controlada, o con cualquier anomalía clínicamente significativa identificada en una exploración física o procedimiento clínico de investigación que, a criterio del investigador o de un subinvestigador, impediría la realización segura del estudio o limitaría la evaluación de eficacia
? Resultados analíticos en el momento de la selección:
- Amilasa y/o lipasa: >3 veces por encima del límite superior normal (LSN) del intervalo analítico
- ALT o AST >3 veces el LSN
- Calcitonina >20 pg/ml (5,9 pmol/l)
? Antecedentes clínicamente relevantes de enfermedad gastrointestinal asociada a náuseas y vómitos prolongados, incluyendo (pero no restringido a): gastroparesia, reflujo gastroesofágico inestable (es decir, empeoramiento) y no controlado (náuseas y vómitos prolongados) en los 6 meses antes de la selección
? Antecedentes de pancreatitis idiopática, pancreatitis crónica, pancreatectomía, cirugía de estómago/gástrica, enfermedad inflamatoria intestinal
? Antecedentes personales o familiares inmediatos de cáncer medular tiroideo o afecciones genéticas que predisponen al cáncer medular tiroideo (p. ej., síndromes de neoplasia endocrina múltiple)

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in HbA1c

Cambio absoluto en el valor de HbA1c desde el inicio hasta la semana 24

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

24 semanas

E.5.2

Secondary end point(s)

Change from baseline in FPG

Change in 2?hour PPG and plasma glucose excursions (2-hour postprandial plasma glucose ? FPG) during the liquid standardized breakfast meal test from baseline

Change in 7-point SMPG profile (i.e, the average and each time point of the 7 points) from baseline

Change in body weight from baseline

Change in total daily basal insulin dose from baseline for patients taking basal insulin

Percentage of patients requiring rescue therapy during the 24-week double-blind treatment period

Documented (PG <60 mg/dl) symptomatic
hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year)

Severe hypoglycemia

Gastrointestinal side effects

Cambio en la GPA desde el inicio hasta la semana 24
Cambio en la GPP a las 2 horas y oscilaciones de la glucosa plasmática (glucosa post-prandrial plasmática a las 2 horas ? GPA) durante la prueba del desayuno estandarizado líquido desde el inicio hasta la semana 24
Cambio en el perfil de SMPG de 7 puntos (es decir, el promedio y en cada uno de los 7 puntos) desde el inicio hasta la semana 24
Cambio en el peso corporal desde el inicio hasta la semana 24
Cambio en la dosis de insulina basal diaria total desde el inicio hasta la semana 24 para pacientes que toman insulina basal
Porcentaje de pacientes que requieren terapia de rescate durante el período del tratamiento doble ciego de 24 semanas
Porcentaje de pacientes que alcanzan HbA1c <7,0 % en la semana 24
Hipoglucemia severa
Efectos secundarios gastrointestinales

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24

Semana 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

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)

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

Bulgaria

Canada

Denmark

Germany

Norway

Peru

Poland

Russian Federation

South Africa

Spain

Sweden

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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

340

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

182

F.4.2.2

In the whole clinical trial

340

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)

No specific plan for treatment or care after the subject has ended the participation in the trial.

No hay un plan específico para el tratamiento o la atención después de que el sujeto haya finalizado la participación en el ensayo.

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

2013-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-31

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-02-18

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