Clinical Trials Register

Summary
EudraCT Number:	2011-002276-16
Sponsor's Protocol Code Number:	1218.60
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:	2011-10-03
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

2011-002276-16

A.3

Full title of the trial

A randomised, double-blind, double-dummy active-comparator controlled study investigating the efficacy and safety of Linagliptin co-administered with metformin QD at bedtime versus metformin BID over 14 weeks in treatment naive type 2 diabetes and insufficient glycaemic control.

Estudio aleatorizado, doble ciego, con doble simulación, controlado con un fármaco de referencia activo para investigar la eficacia y la seguridad de linagliptina coadministrada con metformina una vez al día a la hora de acostarse en comparación con metformina dos veces al día durante 14 semanas en el tratamiento de pacientes sin tratamiento previo con diabetes mellitus de tipo 2 y con un control de la glucemia insuficiente.

A.3.1

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

linagliptin in combination with metformin in treatment naive patients with type 2 diabetes mellitus and insufficient glycaemic control.

linagliptina en combinación con metformina en el tratamiento de pacientes sin tratamiento previo con diabetes mellitus de tipo 2 y control de la glucemia insuficiente.

A.4.1

Sponsor's protocol code number

1218.60

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 España, 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	Boehringer Ingelheim España, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmbH & Co. KG
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	+1-800-243-0127
B.5.5	Fax number	+1-800-821-7119
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	Trajenta
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Inglheim 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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Coated tablet
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	LINAGLIPTIN
D.3.9.1	CAS number	668270-12-0
D.3.9.2	Current sponsor code	BI 1356
D.3.9.4	EV Substance Code	SUB31340
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	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	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	Glucophage
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Serono GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Coated tablet
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	METFORMIN HYDROCHLORIDE
D.3.9.1	CAS number	1115-70-4
D.3.9.4	EV Substance Code	SUB03200MIG
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	500
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	Coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Coated tablet
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

Type 2 diabetes Mellitus

Diabetes Mellitus tipo 2

E.1.1.1

Medical condition in easily understood language

Type 2 Diabetes Mellitus

Diabetes Mellitus tipo 2

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
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

The change from baseline in HbA1c after 14 weeks treatment

Cambio en el nivel de HbA1c respecto a la situación basal después de 14 semanas de tratamiento.

E.2.2

Secondary objectives of the trial

Key sencondary objectives are to assess whether the combination therapy (once daily) has improved tolerability to gastrointestinal (GI) side effects over metformin alone (twice daily), by comparing the composite endpoint of occurrence of treat to target response, defined HbA1c<7.0% and no occurence of moderate or severe metformin pre-specified GI side effects during 14 weeks treatment; and the occurrence of metformin pre-specified moderate or severe GI side effects during 14 weeks treatment.

Los criterios secundarios de valoración más importantes son:
Criterio de valoración compuesto de la aparición de la respuesta de eficacia objetivo, que es un nivel de HbA1c en tratamiento del < 7,0% después de 14 semanas de tratamiento, y no aparición de efectos secundarios GI moderados o graves definidos previamente para la metformina y evaluados por los investigadores durante 14 semanas de tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Diagnosis of Type 2 diabetes mellitus prior to informed consent;
2. Male and female patients on diet and excise regimen who are drug naive, defined as abesense of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization
3. Glycoslylated haemoglobin A1c (HbA1c) >/= 6.5% (48 mmol/mol) to </= 10.0% (86 mmol/mol)at visit 1 (screening);
4. Age>/=18 and </=80 years at visit 1(screening);
5. Body Mass Index(BMI)</= 45kg/m2 at vist 1 (screening);
6. Signed and dated written informed consent by date of visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

1. Diagnóstico de DMT2 antes del consentimiento informado
2. Pacientes de ambos sexos sometidos a un régimen de dieta y ejercicio sin tratamiento
previo, definido como ausencia de cualquier antidiabético oral (ADO) o insulina
durante al menos las 12 semanas previas a la aleatorización
3. Nivel de HbA1c de >/= 6,5% (48 mmol/mol) y </= 10,0% (86 mmol/mol) en la visita 1
(selección)
4. Edad >/=18 18 y </= 80 años en la visita 1 (selección)
5. IMC ? 45 kg/m2 (índice de masa corporal) en la visita 1 (selección)
6. Consentimiento informado por escrito, firmado y fechado el día de la visita 1
conforme a la BPC y a la legislación local

E.4

Principal exclusion criteria

1.Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/L) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (Not on the same day);
2.Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization
3. Myocaridial infarction,stroke or Transient ischemia attack (TIA) within 3 months prior to informed consent;
4. Indication of liver disease/Impaired hepatic function, defined by serum levels of either Aspartate aminotransferase (ALT or SGPT), alanine aminotransferase (AST or SGOT), or alkaline phosphatase above 3 x uppler limit of normal (ULN) as determined at visit 1,
5. Impaired renal function fuction, defined as eGFR< 60ml/min (severe renal impairement, modification of diet in renal disease (MDRD) formula) as determined at run-in phase
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malaborption
7. Medical history of Cancer(except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Blood dyscrasia or any other disorders causing hemolysis or unstable Red Blood Cell (eg. malaria, babesiosis, hamolytic anemia)
9. Contraindications to moetformin according to the local label
10. Treatment with anti-obesity drugs 3 months prior to informed consent or any otehr treatment at the time of screening (i.e. surgery, aggressive diet regimen etc) leading to unstable body weight
12. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
a. are nursing or pregnant or
b. are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to contiune using this method throughout the study and do not agree to submit to periodic pregancy testing during parcipation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
13. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
14. Participation in another trial with application of any investigational drug within 30 days prior to informed consent
15. Any other clinical condition that would jeopardize patients safety while participating in this trial

1. Hiperglucemia no controlada con un nivel de glucosa > 240 mg/dl (> 13,3 mmol/l)
después de una noche en ayunas durante la selección/preinclusión con placebo y
confirmada a través de una segunda medición (no en el mismo día).
2. Tratamiento con cualquier antidiabético oral o insulina en las 12 semanas anteriores a
la aleatorización
3. Síndrome coronario agudo (no STEMI, STEMI y angina de pecho inestable), ictus o
AIT en los 3 meses anteriores al consentimiento informado
4. Indicios de hepatopatía/función hepática alterada, definida por una concentración
sérica de ALT (SGPT), AST (SGOT) o de fosfatasa alcalina 3 veces mayor que el
límite superior de la normalidad (LSN), según la determinación realizada durante la
fase de selección o preinclusión.
5. Función renal alterada, definida como una TFGe < 60 ml/min (fórmula MDRD)
determinada durante la selección o la fase de preinclusión
6. Cirugía bariátrica en los dos últimos años y otras intervenciones quirúrgicas de tipo
gastrointestinal que induzcan a una malabsorción crónica.
7. Antecedentes médicos de cáncer (excepto carcinoma de células basales) o tratamiento
antineoplásico en los últimos 5 años.
8. Discrasias sanguíneas o cualquier trastorno que cause hemólisis o conduzca a una
cifra inestable de eritrocitos (p. ej., malaria, babesiosis, anemia hemolítica).
9. Contraindicaciones de la metformina conforme al etiquetado local
10. Tratamiento con fármacos antiobesidad 3 meses antes del consentimiento informado o
cualquier otro tratamiento en el momento de la selección (es decir, cirugía, regimen
dietético intensivo a criterio de los investigadores, etc.) que produce peso corporal
inestable.
12. Mujeres premenopáusicas (última menstruación ? 1 año antes del consentimiento
informado) que:
a. estén en periodo de lactancia o embarazadas, o
b. sean fértiles y no utilicen un método anticonceptivo fiable o no tengan
previsto seguir utilizándolo durante todo el estudio y no estén de acuerdo en
someterse a pruebas de embarazo periódicas durante su participación en este
estudio. Los métodos anticonceptivos seguros son por, ejemplo, la ligadura de
trompas, los parches transdérmicos, los dispositivos o sistemas intrauterinos
(DIU o SIU), los anticonceptivos orales, implantables o inyectables, la
abstinencia sexual total (si se acepta por parte de las autoridades locales), los
métodos de doble barrera y la vasectomía de la pareja.
13. Antecedentes de alcoholismo o toxicomanía, a juicio de los investigadores, en los 3
meses anteriores al consentimiento informado que pudieran interferir en la
participación en el estudio o cualquier afección en curso que conduzca a una
disminución del cumplimiento de los procedimientos del estudio o de la toma del
fármaco en estudio.
14. Participación en otro ensayo clínico con administración de cualquier otro fármaco en
fase de investigación en los 30 días anteriores al consentimiento informado.
15. Cualquier otra afección clínica que pudiera poner en peligro la seguridad de los
pacientes mientras participen en este ensayo clínico, según el criterio del investigador.

E.5 End points

E.5.1

Primary end point(s)

1: The change from baseline in Glycosylated Hemoglobin A1c (HbA1c) after 14 weeks treatment

1: cambio en el nivel de HbA1c respecto a la situación basal después de 14 semanas de tratamiento

E.5.1.1

Timepoint(s) of evaluation of this end point

1: 14 weeks

1: 14 semanas

E.5.2

Secondary end point(s)

1: Composite endpoint of occurence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% after 14 weeks of treatment, and no occurence of moderate or severe gastrointestinal (GI) side effects during 14 weeks of treatment

2: Change from baseline in fasting plasma glucose (FPG) after 14 weeks of treatment

3: Metformin pre-specified GI symptom intensity score assessed by investigators during 14 weeks of treatment

4: Metformin pre-specified GI symptom intensty score assessed by patients during 14 weeks of treatment

5: Composite endpoint of occurrence of treat to target efficacy response, that is an HbA1c under treatment of <6.5% after 14 weeks of treatment, and on occurence of moderate or severe metformin pre-specified GI side effects assessed by investigators

6: Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment)

7: Occurence of metformin pre-specified moderate to severe GI side effects assessed by investigators during 14 weeks of treatment

8: Occurrence of relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment)

9: Composite endponit of occurence of relative efficacy response(HbA1c lowering by at least 0.5% after 14 weeks of treatment) and no occurence of moderate and severe metformin pre-specified GI side effects assessed by the investigators during 14 weeks

10: Compostie endpoint of occurrence of relative efficacy response(HbA1c lowering by at least 0.8% after 14 weeks of treatment) and no occurrence of moderate and severe metformin pre-specified GI side effects assessed by investigators during 14 weeks

11: change from baseline in HbA1c by visit over time

12: change from baseline in body weight by visit over time

1: Criterio de valoración compuesto de la aparición de la respuesta de eficacia objetivo,
que es un nivel de HbA1c en tratamiento del < 7,0% después de 14 semanas de
tratamiento, y no aparición de efectos secundarios GI moderados o graves definidos
previamente para la metformina y evaluados por los investigadores durante 14 semanas
de tratamiento.
2: Aparición de efectos secundarios GI moderados o graves definidos previamente para la
metformina y evaluados por los investigadores durante 14 semanas de tratamiento
3: Cambio respecto a la situación basal en las concentraciones de glucosa plasmática en
ayunas (GPA) tras 14 semanas de tratamiento.
4: Puntuaciones de la intensidad de los síntomas GI definidos previamente para la
metformina, evaluados por los investigadores, durante 14 semanas de tratamiento
5: Puntuaciones de la intensidad de los síntomas GI definidos previamente de la
metformina, evaluados por los pacientes, durante 14 semanas de tratamiento
6: Criterio de valoración compuesto de la aparición de la respuesta de eficacia objetivo, es
decir, un nivel de HbA1c en tratamiento del < 6,5% tras 14 semanas de tratamiento y la
no aparición de efectos secundarios GI moderados o graves definidos previamente para
la metformina y evaluados por los investigadores durante 14 semanas de tratamiento.
7: Consecución de una respuesta de eficacia relativa (disminución en el nivel de HbA1c de
al menos un 0,5% tras 14 semanas de tratamiento).
8: Consecución de una respuesta de eficacia relativa (disminución en el nivel de HbA1c de
al menos un 0,8% tras 14 semanas de tratamiento).
9: Criterio de valoración compuesto de la consecución de respuesta de eficacia relativa
(disminución en el nivel de HbA1c de al menos un 0,5% tras 14 semanas de tratamiento)
y no aparición de efectos secundarios GI moderados o graves definidos previamente para
la metformina y evaluados por los investigadores durante 14 semanas de tratamiento.
10: Criterio de valoración compuesto de la consecución de respuesta de eficacia relativa
(disminución en el nivel de HbA1c de al menos un 0,8% tras 14 semanas de tratamiento)
y no aparición de efectos secundarios GI moderados o graves definidos previamente para
la metformina y evaluados por los investigadores durante 14 semanas de tratamiento.
11: Cambio con respecto a la situación basal en el valor de la HbA1c por visita en función del
tiempo.
12: Cambio con respecto a la situación basal en el valor del peso corporal por visita en
función del tiempo.

E.5.2.1

Timepoint(s) of evaluation of this end point

1: 14 weeks

2: 14 weeks

3: 14 weeks

4: 14 weeks

5: 14 weeks

6: 14 weeks

7: 14 weeks

8: 14 weeks

9: 14 weeks

10: 14 weeks

11: 14 weeks

12:14 weeks

1: 14 semanas

2: 14 semanas

3: 14 semanas

4: 14 semanas

5: 14 semanas

6: 14 semanas

7: 14 semanas

8: 14 semanas

9: 14 semanas

10: 14 semanas

11: 14 semanas

12:14 semanas

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

Yes

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

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

China

Guatemala

Hong Kong

India

Lebanon

Mexico

Peru

Philippines

Taiwan

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

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:

500

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

210

F.4.2.2

In the whole clinical trial

1360

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)

There is no plan for treatment care after subjects end participation in the trial

No hay ningún plan de tratamiento tras el fin de 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

2011-11-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-11-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-03-05

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