Clinical Trials Register

Summary
EudraCT Number:	2011-005878-37
Sponsor's Protocol Code Number:	039(C)SC11063
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:	2012-08-09
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

2011-005878-37

A.3

Full title of the trial

A randomized, double-blind study comparing the efficacy and safety of Trazodone OAD and venlafaxine XR in the treatment of patients with Major Depressive Disorder.

Estudio doble ciego aleatorizado para comparar el perfil de eficacia y seguridad de trazodona DUD y venlafaxina LP en el tratamiento de pacientes con trastorno depresivo mayor.

A.3.1

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

Efficacy and safety of trazodone OAD and venlafaxine XR in the treatment of Major Depressive Disorder.

Eficacia y seguridad de trazodona DUD y venlafaxina LP en el tratamiento de trastorno depresivo mayor.

A.3.2

Name or abbreviated title of the trial where available

Trazodone OAD in Major Depressive Disorder

Trazodona DUD en trastorno depresivo mayor

A.4.1

Sponsor's protocol code number

039(C)SC11063

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	Aziende Chimiche Riunite Angelini Francesco - ACRAF S.p.A.
B.1.3.4	Country	Italy
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	Aziende Chimiche Riunite Angelini Francesco - ACRAF S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Aziende Chimiche Riunite Angelini Francesco -ACRAF S.p.A.
B.5.2	Functional name of contact point	Clinical trial application unit
B.5.3	Address:
B.5.3.1	Street Address	P.le della stazione snc
B.5.3.2	Town/ city	S.Palomba - Pomezia (Roma)
B.5.3.3	Post code	00040
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390691045335
B.5.5	Fax number	+39069194333
B.5.6	E-mail	g.orticelli@angelini.it

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	Trittico
D.2.1.1.2	Name of the Marketing Authorisation holder	Aziende Chimiche Riunite Angelini Francesco-ACRAF SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Comprimidos recubiertos con película de liberación prolongada de trazodona HCL con Contramid®
D.3.2	Product code	039(C)
D.3.4	Pharmaceutical form	Prolonged-release 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	clorhidrato de trazodona
D.3.9.1	CAS number	25332-39-2
D.3.9.2	Current sponsor code	039
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB15596MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	EFEXOR 28 CPS 37.5 MG R.P.
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA, srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Venlafaxina XR
D.3.4	Pharmaceutical form	Prolonged-release capsule
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	clorhidrato de venlafaxina
D.3.9.1	CAS number	99300-78-4
D.3.9.4	EV Substance Code	SUB05087MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	37.5
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	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	Trittico
D.2.1.1.2	Name of the Marketing Authorisation holder	Aziende Chimiche Riunite Angellini Francesco - ACRAF SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Comprimidos recubiertos con película de liberación prolongada de trazodona HCL con Contramid®
D.3.2	Product code	039(C)
D.3.4	Pharmaceutical form	Prolonged-release 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	Clorhidrato de trazodona
D.3.9.1	CAS number	25332-39-2
D.3.9.2	Current sponsor code	039
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB15596MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	150
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	Yes
D.2.1.1.1	Trade name	EFEXOR 28 CPS 75 MG R.P.
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Venlafaxina XR
D.3.4	Pharmaceutical form	Prolonged-release capsule
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	clorhidrato de venlafaxina
D.3.9.1	CAS number	99300-78-4
D.3.9.4	EV Substance Code	SUB05087MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	75
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: 5
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	Comprimidos recubiertos con película de liberación prolongada de trazodona HCL con Contramid®
D.3.2	Product code	039(C)
D.3.4	Pharmaceutical form	Prolonged-release 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	Clorhidrato de trazodona
D.3.9.1	CAS number	25332-39-2
D.3.9.2	Current sponsor code	039
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB15596MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	75
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Major depressive disorder

Trastorno depresivo mayor

E.1.1.1

Medical condition in easily understood language

Depression

Depresión

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	SOC
E.1.2	Classification code	10037175
E.1.2	Term	Psychiatric disorders
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	HLGT
E.1.2	Classification code	10012375
E.1.2	Term	Depressed mood disorders and disturbances
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	HLT
E.1.2	Classification code	10012401
E.1.2	Term	Depressive disorders
E.1.2	System Organ Class	10037175 - Psychiatric 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 study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine extended release (venlafaxine XR) after an 8-week treatment period in patients with major depressive disorder.

El objetivo del estudio es evaluar la eficacia y la seguridad de trazodona DUD en comparación con venlafaxina de liberación prolongada (venlafaxina LP) tras un período de tratamiento de 8 semanas en pacientes con trastorno depresivo mayor.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Outpatients; Men or women 18-75 years of age (limits included); diagnosis of MDD according to DSM-IV; HAMD -17 ? 18 at screening and baseline visits; symptoms of depression for at least 1 month; patients legally capable to give their consent to participate the study, subjects must agree not to start a pregnancy from the signature of the informed consent (childbearing women).

Hombres y mujeres 18-75 años de edad (limites incluidos) sin limitación de raza;con un diagnóstico de TDM con arreglo a los criterios de DSM-IV evaluados utilizando la escala MINI; pacientes ambulatorios; escala HAMD > 18 en las visitas de selección e inicial con una disminución no superior al 20 % entre las dos visitas; síntomas de depresión durante un período mínimo de 1 mes; pacientes con capacidad legal para otorgar su consentimiento para participar en el estudio, y capaces de firmar y datar el consentimiento informado escrito antes de la inclusión en el estudio; las mujeres potencialmente fértiles deben comprometerse a no quedarse embarazadas desde el momento de la firma del consentimiento informado hasta 30 días después de la última administración del producto experimental.

E.4

Principal exclusion criteria

Use of venlafaxine or trazodone within the previous 6 months; liver or renal clinically significant disease; myocardial infarction (within 6 months); positive present history of glaucoma; risk factors for TdP; clinically significant electrolyte values; concomitant treatment with drugs known for QT prolongation; QTcF > 450msec; major depression resistant to medical treatments; seizure events; alcohol or psychoactive abuse or addiction; suicide risk (HAMD, criterion 3 value ? 3); present history of psychiatric disorder rather than MDD; pregnant or lactating women; use of antipsychotic, anxiolytic or sedative hypnotic; use of drugs with psychotropic effect; treatment with CYP3A4 inhibitors; hyperthyroidism;clinically significant alterations at physical examination, vital signs, ECG and laboratory exams; vulnerable subjects.

Uso de venlafaxina o trazodona en los 6 meses anteriores; hepatopatía o nefropatía importantes; infarto de miocardio en los 6 meses anteriores al inicio del tratamiento; enfermedad actual de glaucoma; valores de electrolitos fuera de los límites normales de laboratorio y considerados clínicamente trascendentes por el Investigador; tratamiento concomitante con fármacos que prolongan el intervalo QT; valores de QTcF > 450 ms en el ECG realizado en la visita de selección; antecedentes de depresión resistente a tratamientos médicos; antecedentes de epilepsia; antecedentes de consumo excesivo o adicción crónica al alcohol o a psicofármacos; riesgo grave de suicido (escala HAMD, criterio 3 con un valor ? 3); presencia de cualquier trastorno psiquiátrico primario distinto de depresión mayor; antecedentes de presencia de trastorno bipolar, cualquier trastorno psicótico, trastorno mental provocado por afecciones generales; embarazo, lactancia o mujer con resultado positivo en una prueba de embarazo; uso de antipsicóticos, ansiolíticos o sedantes-somníferos; uso de cualquier psicofármaco con efectos sobre el sistema nervioso central; uso de no psicofármacos con efectos psicotrópicos (ej. bloqueantes de los receptores adrenérgicos ?) en los 7 días anteriores a la visita inicial, salvo que se haya mantenido una dosis estable del medicamento durante un período mínimo de 1 mes (3 meses en el caso de medicamentos hormonales o antitiroideos) antes de la visita inicial; tratamiento concomitante con inhibidores de la CYP3A4; hipertiroidismo, aunque esté corregido con fármacos; inicio o interrupción de psicoterapia en los 6 meses anteriores a la visita de selección; anomalías de trascendencia clínica detectadas en la exploración física, los signos vitales, el ECG o las pruebas analíticas correspondientes a la visita de selección; pacientes vulnerables.

E.5 End points

E.5.1

Primary end point(s)

Mean change from baseline in HAMD score at final visit

Variación media con respecto a la visita inicial en la puntuación HAMD en la visita final.

E.5.1.1

Timepoint(s) of evaluation of this end point

Treatment day 56 (final visit)

Tratamiento del día 56 (visita final)

E.5.2

Secondary end point(s)

Mean change from baseline in MADRS score at final visit; CGI-Severity of illness and CGI-Global improvement at final visit; rate of responders defined as patients with a 50% decrease with respect to baseline on the HAMD score at final visit; rate of patients with remission (HAMD score ? 7) at final visit.

Variación media con respecto a la visita inicial en la puntuación MADRS en la Visita final; impresión clínica global de gravedad (CGI-S) e impresión clínica global de mejoría (CGI-I) en la visita final; tasa de pacientes que respondieron favorablemente al tratamiento, definidos como pacientes con una disminución mínima de un 50 % en la puntuación HAMD con respecto a la visita inicial en la visita final; tasa de pacientes con remisión (puntuación HAMD < 7) en la visita final

E.5.2.1

Timepoint(s) of evaluation of this end point

Treatment day 56 (final visit)

Tratamiento en el día 56 (visita final)

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Última visita del último sujeto

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:

300

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

360

F.4.2.2

In the whole clinical trial

360

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)

Final visit responders may continue treatment with the same drug administered during the study. A third physician will open the treatment code and prescribe the formulation available on the market. Non responders at the final visit will reduce the dose in 1-3 weeks based on the maximum dose administered during the study.

Los pacientes que responden favorablemente al tratamiento pueden continuar con el tratamiento. Un profesional independiente abrirá el código del tratamiento y prescribirá la misma medicación recibida por el paciente durante el ensayo, de conformidad con la formulación comercializada. Los pacientes que no responden al tratamiento en la visita final seguirán un programa de reducción de dosis de 1 a 3 semanas de duración.

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

2012-08-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-31

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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