Clinical Trials Register

Summary
EudraCT Number:	2012-002271-34
Sponsor's Protocol Code Number:	1275.10
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:	2012-10-29
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

2012-002271-34

A.3

Full title of the trial

A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy.

Estudio de fase III, aleatorizado, doble ciego y de grupos paralelos para evaluar la eficacia y seguridad de linagliptina 5 mg en comparación con placebo, administrada por vía oral a dosis fijas en combinación con
empagliflozina 10 mg o 25 mg durante 24 semanas, en pacientes con diabetes mellitus tipo 2 con un control insuficiente de la glucemia después de 16 semanas de tratamiento con empagliflozina 10 mg o
25 mg además del tratamiento de base con metformina.

A.3.1

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

A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.

Estudio para evauar la eficacia y seguridad de linagliptina 5 mg en combinación con empagliflozina 10 mg o 25 mg en pacientes con diabetes mellitus tipo 2 con niveles de glucosa que no han sido bien controlados tras 16 semanas de tratamiento con empagliflozina 10 mg o 25 mg y metformina.

A.4.1

Sponsor's protocol code number

1275.10

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	0018002430127
B.5.5	Fax number	0018009217119
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	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	Empagliflozin + Linagliptin
D.3.2	Product code	BI 10773 + BI 1356
D.3.4	Pharmaceutical form	Film-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	Empagliflozin
D.3.9.2	Current sponsor code	BI 10773
D.3.9.3	Other descriptive name	Empagliflozin
D.3.9.4	EV Substance Code	SUB35915
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Linagliptin
D.3.9.2	Current sponsor code	BI 1356
D.3.9.3	Other descriptive name	LINAGLIPTIN
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	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	Empagliflozin + Linagliptin
D.3.2	Product code	BI 10773 + BI 1356
D.3.4	Pharmaceutical form	Film-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	Empagliflozin
D.3.9.2	Current sponsor code	BI 10773
D.3.9.3	Other descriptive name	Empagliflozin
D.3.9.4	EV Substance Code	SUB35915
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Linagliptin
D.3.9.2	Current sponsor code	BI 1356
D.3.9.3	Other descriptive name	LINAGLIPTIN
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: 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	Empagliflozin
D.3.2	Product code	BI 10773
D.3.4	Pharmaceutical form	Film-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	Empagliflozin
D.3.9.2	Current sponsor code	BI 10773
D.3.9.3	Other descriptive name	Empagliflozin
D.3.9.4	EV Substance Code	SUB35915
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	10
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: 4
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	Empagliflozin
D.3.2	Product code	BI 10773
D.3.4	Pharmaceutical form	Film-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	Empagliflozin
D.3.9.2	Current sponsor code	BI 10773
D.3.9.3	Other descriptive name	Empagliflozin
D.3.9.4	EV Substance Code	SUB35915
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	25
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	Film-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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-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

Diabetes mellitus type 2 is the medical condition to be investiagted

Diabetes mellitus tipo 2.

E.1.1.1

Medical condition in easily understood language

A medical condition called diabetes which is characterized by elevated glucose levels.

Enfermedad conocida como diabetes que se caracteriza por niveles elevados de glucosa.

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

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin

El objetivo del estudio es investigar la eficacia, seguridad y tolerabilidad de linagliptina 5 mg una vez al día en comparación con placebo administrada durante 24 semanas en pacientes con T2DM con un control inadecuado con el tratamiento con empagliflozina 10 mg o 25 mg y la dosis máxima tolerada de metformina.

E.2.2

Secondary objectives of the trial

Fasting plasma glucose (FPG) change from baseline (Visit 5) at 24 weeks (or Visit 9)

Cambio en la glucemia plasmática en ayunas (FPG) respecto al valor basal (visita 5) a las 24 semanas (o Visita 9).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients treated with metformin for at least 12 weeks
HbA1c ? 8.0% (64 mmol/mol) and ? 10.5% (91 mmol/mol) at Visit 1 for the 16 week open label treatment period.
HbA1c ? 7.0% (53 mmol/mol) and ? 10.5 % (91 mmol/mol) at Visit 4 for the 24 week double-blind treatment period.
Body Mass Index (BMI) ?45 kg/m2 at Visit 1 (screening)

Pacientes tratados con metformina durante al menos 12 semanas.
HbA1c ? 8,0 % (64 mmol/mol) y ? 10,5 % (91 mmol/mol) en la visita 1 para el período de tratamiento en abierto de 16 semanas.
HbA1c ? 7,0 % (53 mmol/mol) y ? 10,5 % (91 mmol/mol) en la visita 4 para el periodo de tratamiento doble ciego de 24 semanas.
Índice de masa corporal (BMI) ? 45 kg/m2 en la visita 1 (selección).

E.4

Principal exclusion criteria

Uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/L) after an overnight fast during the open label period (from Visit 2 to Visit 4) and placebo add on "run-in" period (Visit 4 to Visit 5).
Any other antidiabetic drug within 12 weeks prior to Visit 2 randomization (except metformin background therapy)
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) based on Visit 1 and Visit 4 laboratory parameters.
Impaired renal function, defined as eGFR <60 ml/min/1.73 m2 (MDRD formula) as determined during screening (Visit 1) or placebo add on "run-in" (Visit 4)
Known blood dyscrasias or any disorders causing haemolysis or unstable red blood cell count (e.g. malaria, babesiosis, haemolytic anaemia) due to the short lifespan of the RBC and its impact on HbA1c.
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) within 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
Current treatment with systemic steroids (other than inhaled or topical steroids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other documented uncontrolled endocrine disorder except T2DM.
Pre-menopausal women (last menstruation ?1 year prior to informed consent) who are nursing or pregnant.

Hiperglucemia no controlada con un nivel de glucemia > 270 mg/dl (> 15,0 mmol/l) después de ayuno nocturno durante el período en abierto (de la visita 2 a la visita 4) y el período de preinclusión con placebo complementario (visita 4 a visita 5).

Tratamiento con cualquier otro antidiabético en las 12 semanas anteriores a la aleatorización en la visita 2 (excepto el tratamiento de base con metformina).

Síndrome coronario agudo (IMSEST, IMEST y angina de pecho inestable), ictus o AIT en los 3 meses anteriores a la firma del consentimiento informado.

Indicios de hepatopatía, definida por una concentración sérica de ALT (SGPT), AST (SGOT) o fosfatasa alcalina superior a 3 veces el límite superior de la normalidad (ULN), según los parámetros analíticos de la visita 1 y visita 4.

Insuficiencia renal, definida como eGFR < 60 ml/min/1,73 m2 (fórmula MDRD) según determinación durante la selección (visita 1) o la preinclusión con placebo complementario (visita 4)

Discrasias sanguíneas o cualquier trastorno que cause hemólisis o cifra inestable de eritrocitos (p. ej., paludismo, babesiosis, anemia hemolítica) debido a la corta vida de los eritrocitos y su influencia sobre la HbA1c.

Tratamientos con fármacos contra la obesidad (p. ej., sibutramina, orlistat) en los 3 meses anteriores al consentimiento informado o cualquier otro tratamiento en el momento de la selección (es decir, intervención quirúrgica, dieta radical de adelgazamiento, etc.) que provoquen un peso corporal inestable.

Tratamiento actual con corticosteroides sistémicos (aparte de corticosteroides inhalados o tópicos) en el momento del consentimiento informado o cambio en la pauta de administración de hormonas tiroideas en las 6 semanas anteriores al consentimiento informado o cualquier otro trastorno endocrino no controlado confirmado con excepción de la T2DM

Mujeres premenopáusicas (última menstruación ? 1 año antes del consentimiento informado) que estén en periodo de lactancia o embarazadas

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the change of HbA1c after 24 weeks of treatment (at week 24 or Visit 9) from baseline (Visit 5).

El criterio principal de valoración de este estudio es el cambio en la HbA1c tras 24 semanas
de tratamiento (en la semana 24 o visita 9) respecto al valor basal (visita 5).

E.5.1.1

Timepoint(s) of evaluation of this end point

After 24 weeks of treatment (Visit 9) from baseline (Visit 5).

Tras 24 semanas de tratamiento (visita 9) respecto al valor basal (visita 5).

E.5.2

Secondary end point(s)

Fasting plasma glucose (FPG) change from baseline (Visit 5) at 24 weeks (or Visit 9)

Cambio en la glucemia plasmática en ayunas (FPG) respecto al valor basal (visita 5) a las 24 semanas (o Visita 9).

E.5.2.1

Timepoint(s) of evaluation of this end point

After 24 weeks of treatment (Visit 9) from baseline (Visit 5).

Tras 24 semanas de tratamiento (visita 9) respecto al valor basal (visita 5).

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)

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

Argentina

Australia

Canada

Germany

India

Italy

Peru

Portugal

Russian Federation

Spain

Sri Lanka

Ukraine

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

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:

517

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

173

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Illiterate

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

228

F.4.2.2

In the whole clinical trial

690

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-12-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-10

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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