Clinical Trials Register

Summary
EudraCT Number:	2013-001643-30
Sponsor's Protocol Code Number:	CLCZ696A2320
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-07-12
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

2013-001643-30

A.3

Full title of the trial

An 8-week randomized, double-blind, placebo-controlled factorial study to evaluate the efficacy and safety of LCZ696 alone and in combination with amlodipine in patients with essential hypertension

Estudio aleatorizado, doble ciego, controlado con placebo, factorial de 8
semanas de duración para evaluar la eficacia y la seguridad de LCZ696 solo
y en combinación con amlodipino en pacientes con hipertensión esencial

A.3.1

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

An 8-week study to evaluate the efficacy (blood pressure lowering effect) and safety of LCZ696 given alone and in combination with amlodipine

Estudio de 8 semanas para evaluar la eficacia (efecto en la disminución de
la presión sanguínea) y seguridad de LCZ696 solo y en combinación con
amlodipino.

A.4.1

Sponsor's protocol code number

CLCZ696A2320

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Farmacéutica S. A
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Pharma Services AG, Switzerland
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farmacéutica S.A
B.5.2	Functional name of contact point	departamento Médico
B.5.3	Address:
B.5.3.1	Street Address	Gran Via de les Corts Catalanes 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900353036
B.5.5	Fax number	+34932479903
B.5.6	E-mail	eecc.novartis@novartis.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	LCZ696
D.3.4	Pharmaceutical form	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	NA
D.3.9.1	CAS number	936623-90-4
D.3.9.2	Current sponsor code	LCZ696
D.3.9.3	Other descriptive name	LCZ696
D.3.9.4	EV Substance Code	SUB30457
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	200
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	Amlodipine Hexal
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
D.2.1.2	Country which granted the Marketing Authorisation	Turkey
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	amlodipine besylate
D.3.4	Pharmaceutical form	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	NA
D.3.9.3	Other descriptive name	AMLODIPINE BESILATE
D.3.9.4	EV Substance Code	SUB12864MIG
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.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	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	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

Essential hypertension

Hipertensión esencial

E.1.1.1

Medical condition in easily understood language

Patients with high blood pressure

Pacientes con presión sanguínea elevanda.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10015488
E.1.2	Term	Essential hypertension
E.1.2	System Organ Class	10047065 - Vascular 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 blood pressure lowering effect and safety of LCZ696 when given alone and in combination with amlodipine in patients with essential hypertension.

Evaluar la eficacia (efecto de disminución de la presión arterial) y la
seguridad de LCZ696 cuando se administra solo y en combinación con
amlodipino en pacientes con hipertensión esencial.

E.2.2

Secondary objectives of the trial

1.evaluate efficacy of LCZ696 cmp to placebo, measured by change in mean sitting BP (msDBP) from BS after 8 weeks treatment in patients with essential HT.
2.evaluate efficacy of combination of LCZ696 and amlodipine cmp to monotherapy, measured by change msDBP from BS after 8 weeks treatment in pts with essential HT.
3.evaluate office and ambulatory pulse pressure for all trtment groups after 8 wks trtment.
4.evaluate efficacy of LCZ696 cmp to placebo, measured by change in mean 24-hour ambulatory (maSBP), mean 24-hour ambulatory (maDBP), daytime and nighttime maSBP/maDBP, trough/peak ratios of maSBP and maDBP from baseline after 8 wks trtment in a subset of patients with essential HT.
5.evaluate efficacy of combination of LCZ696 and amlodipine compared to monotherapy, measured by change in mean 24-hour ambulatory maSBP), mean 24-hour ambulatory (maDBP), daytime and nighttime maSBP/maDBP from baseline after 8 weeks treatment in a subset of patients with essential HT.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

ABPM- Sub Study

Objectives:
To evaluate the efficacy of LCZ696 200mg and 400mg compared to placebo, as measured
by change in mean 24-hour ambulatory SBP (maSBP), mean 24-hour ambulatory DBP(maDBP), daytime and nighttime maSBP/maDBP, trough/peak ratios of maSBP and maDBP from baseline after 8 weeks of treatment in a subset of patients with essential hypertension.

To evaluate the efficacy of combination of LCZ696 and amlodipine (200/5mg, 200/10mg, 400/5mg and 400/10 mg) compared to monotherapy, as measured by change in mean 24-hour ambulatory SBP (maSBP), mean 24-hour ambulatory DBP (maDBP), daytime and nighttime maSBP/maDBP from baseline after 8 weeks of treatment in a subset of patients with essential hypertension.

Sub-estudio de MAPA

Objetivos:
Evaluar la eficacia de LCZ696 200mg y 400mg comparado con placebo midiendo el cambio en la PAS media ambulatoria de 24 horas (PASma), PAD media ambulatoria de 24 horas (PADma), PADma/PADma diurnas y nocturnas, relación pico/valle de PASma y PADma desde la basal hasta 8 semanas de tratamiento en un subgrupo de pacientes con hipertensión esencial.

Evaluar la eficacia de la combinación de LCZ696 y amlodipino en comparación con la monoterapia, midiendo el cambio en la PAS media ambulatoria de 24 horas (PASma), PAD media ambulatoria de 24 horas (PADma), PASma/PADma diurnas y nocturnas desde la basal hasta 8 semanas de tratamiento en un subgrupo de pacientes con hipertensión esencial.

E.3

Principal inclusion criteria

1.Male or female outpatients.
2.Patients with mild-to- moderate hypertension, untreated or currently taking antihypertensive therapy.
3.Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1)
must have an msSBP ?150 mmHg and<180 mmHg at the randomization visit and msSBP ?140 mmHg <180 mmHg at the preceding visit.
4.Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP? 150 mmHg and <180 mmHg at both the randomization visit and the preceding visit.
5.Patients must have an absolute difference of ?15 mmHg in msSBP between the randomization visit and the preceding visit.
6.Ability to communicate and comply with all study requirements and demonstrate good medication compliance (? 80% compliance rate) during the treatment run-in period.

1. El consentimiento informado por escrito se debe obtener antes de realizar cualquier evaluación.
2. Pacientes con hipertensión de leve a moderada no tratados o que estén recibiendo actualmente tratamiento antihipertensivo.
3. Pacientes tratados (que hayan recibido tratamiento antihipertensivo durante las 4 semanas anteriores a la visita 1) que tengan una PASms?150 mmHg y <180 mmHg en la visita de aleatorización (visita 201) y una PASms ?140 mmHg y <180 mmHg en la visita inmediatamente
anterior a la visita 201 (visita 102 o 103).
4. Pacientes no tratados (con diagnóstico reciente de hipertensión esencial o que tengan antecedentes de hipertensión pero no hayan recibido fármacos antihipertensivos durante al menos 4 semanas antes
de la visita 1 que tengan una PASms ?150 mmHg y <180 mmHg tanto en la visita 1 como en la visita 201.
5. Pacientes que tengan una diferencia absoluta ?15 mmHg en la PASms entre la visita 201 y la visita inmediatamente anterior.
6. Capacidad para comunicar y cumplir todos los requisitos del estudio y demostrar un buen cumplimento de la medicación (tasa de cumplimiento ? 80%) durante el periodo de preinclusión del tratamiento.

E.4

Principal exclusion criteria

1.Severe hypertension (msDBP ?110 mmHg and/or msSBP ? 180 mmHg).
2.History of angioedema, drug- related or otherwise.
3.History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing?s disease, pheochromocytoma, polycystic kidney disease, and drug- induced hypertension.
4.Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
5.History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
6.Pregnant or lactating women.
7.Women of child-bearing potential not using highly effective methods of contraception.

1.Hipertensión severa (PADms ?110 mmHg y/o PASms ? 180 mmHg).
2.Antecedentes de angioedema, relacionado o no con el fármaco.
3.Antecedentes o signos de alguna forma secundaria de hipertensión, incluyendo, entre otros: hipertensión renal parenquimatosa, hipertensión renovascular (estenosis de la arterial renal unilateral o bilateral), coartación aórtica, hiperaldosteronismo primario, enfermedad de Cushing, feocromocitoma, enfermedad renal poliquística e hipertensión provocada por fármacos.
4.Accidente isquémico transitorio (AIT) durante los 12 meses anteriores a la visita 1 o cualquier antecedente de accidente cerebrovascular.
5. Antecedentes de infarto de miocardio, cirugía de baipás coronario o cualquier intervención coronaria percutánea (ICP) durante los 12 meses anteriores a la visita 1.
6. Mujeres embarazadas o en periodo de lactancia.
7. Mujeres en edad fértil que no utilicen métodos anticonceptivos altamente eficaces.
Para el resto de criterios consultar protocolo.

E.5 End points

E.5.1

Primary end point(s)

1.Change from baseline in mean sitting systolic blood pressure (msSBP) of LCZ696 monotherapy compared to placebo.
2.Change from baseline in mean sitting systolic blood pressure (msSBP) of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone.

1. Cambio en la presión arterial sistólica media en sedestación con la monoterapia con LCZ696 comparado con placebo respecto a la basal.
2. Cambio en la presión arterial sistólica media en sedestación con la combinación de LCZ696 y amlodipino comparado con LCZ696 y amlodipino solo respecto a la basal.

E.5.1.1

Timepoint(s) of evaluation of this end point

1.at baseline, 8 weeks
2.at baseline, 8 weeks

1. Respecto a la basal, 8 semanas
2. Respecto a la basal, 8 semanas

E.5.2

Secondary end point(s)

1. To evaluate the efficacy of LCZ696 200mg and 400mg compared to placebo, as measured by change in mean sitting diastolic BP (msDBP) from baseline after 8 weeks of treatment in patients with essential hypertension.
2. To evaluate the efficacy of combination of LCZ696 and amlodipine (200/5mg, 200/10mg, 400/5mg and 400/10 mg) compared to monotherapy, as measured by change in msDBP from baseline after 8 weeks of treatment in patients with essential hypertension.
3. To evaluate office and ambulatory pulse pressure for all treatment groups after 8 weeks of treatment.
4. To evaluate the efficacy of LCZ696 200mg and 400mg compared to placebo, as measured by change in mean 24-hour ambulatory SBP (maSBP), mean 24-hour ambulatory DBP (maDBP), daytime and nighttime maSBP/maDBP, trough/peak ratios of maSBP and maDBP from baseline after 8 weeks of treatment in a subset of patients with essential hypertension.
5. To evaluate the efficacy of combination of LCZ696 and amlodipine (200/5mg, 200/10mg, 400/5mg and 400/10 mg) compared to monotherapy, as measured by change in mean 24-hour ambulatory SBP (maSBP), mean 24-hour ambulatory DBP (maDBP), daytime and nighttime maSBP/maDBP from baseline after 8 weeks of treatment in a subset of patients with essential hypertension.
6. To assess the proportion of patients achieving blood pressure control (msSBP<140 mmHg and msDBP <90 mmHg) for all treatment groups after 8 weeks of treatment.
7. To assess the proportion of patients achieving a successful response in msSBP (< 140 mmHg or a reduction ? 20 mmHg from baseline) for all treatment groups after 8 weeks of treatment.
8. To assess the proportion of patients achieving a successful response (msDBP < 90 mmHg or a reduction ? 10 mmHg from baseline) for all treatment groups after 8 weeks of treatment.
9. To evaluate the safety of LCZ696 and its combination with amlodipine (200/5mg, 200/10mg, 400/5mg and 400/10 mg) in patients with essential hypertension.

1. Evaluar la eficacia de LCZ696 200 mg y 400 mg en comparación con placebo, midiendo el cambio en la PA diastólica media en sedestación (PADms) desde la basal hasta 8 semanas de tratamiento en pacientes con hipertensión esencial.
2. Evaluar la eficacia de la combinación de LCZ696 y amlodipino (200/5 mg, 200/10 mg, 400/5 mg y 400/10 mg) en comparación con la monoterapia, midiendo el cambio en la PADms desde la basal hasta 8 semanas de tratamiento en pacientes con hipertensión esencial.
3. Evaluar la presión de pulso en consulta y ambulatoria en todos los grupos de tratamiento después de 8 semanas de tratamiento.
4. Evaluar la eficacia de la combinación de LCZ696 200 mg y 400 mg comparado con placebo, midiendo el cambio en la PAS media ambulatoria de 24 horas (PASma), PAD media ambulatoria de 24 horas (PADma), PASma/PADma diurnas y nocturnas, relación valle/pico de PASma y PADma desde la basal hasta 8 semanas de tratamiento en un subgrupo de pacientes con hipertensión esencial.
5. Evaluar la eficacia de la combinación de LCZ696 y amlodipino (200/5 mg, 200/10 mg, 400/5 mg y 400/10 mg) en comparación con la monoterapia, midiendo el cambio en la PAS media ambulatoria de 24 horas (PASma), PAD media ambulatoria de 24 horas (PADma), PASma/PADma diurnas y nocturnas desde la basal hasta 8 semanas de tratamiento en un subgrupo de pacientes con hipertensión esencial.
6. Evaluar la proporción de pacientes que alcancen un control de la presión arterial (PASms<140 mmHg y PADms <90 mmHg) en todos los grupos de tratamiento después de 8 semanas de tratamiento.
7. Evaluar la proporción de pacientes que alcancen una respuesta satisfactoria en la PASms (<140 mmHg o una reducción ? 20 mmHg respecto a la basal) en todos los grupos de tratamiento después de 8 semanas de tratamiento.
8. Evaluar la proporción de pacientes que alcancen una respuesta satisfactoria (PADms <90 mmHg o una reducción ? 10 mmHg respecto a la basal) en todos los grupos de tratamiento después de 8 semanas de tratamiento.
9. Evaluar la seguridad de LCZ696 y su combinación con amlodipino (200/5 mg, 200/10 mg, 400/5 mg y 400/10 mg) en pacientes con hipertensión esencial.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. from baseline after 8 weeks of treatment.
2. from baseline after 8 weeks of treatment.
3. after 8 weeks of treatment.
4. from baseline after 8 weeks of treatment.
5. from baseline after 8 weeks of treatment.
6. after 8 weeks of treatment.
7. after 8 weeks of treatment.
8. after 8 weeks of treatment.
9. after 8 weeks of treatment.

1. De la basal hasta 8 semanas de tratamiento.
2. De la basal hasta 8 semanas de tratamiento.
3. Después de 8 semanas de tratamiento.
4. De la basal hasta 8 semanas de tratamiento.
5. De la basal hasta 8 semanas de tratamiento.
6. Después de 8 semanas de tratamiento.
7. Después de 8 semanas de tratamiento.
8. Después de 8 semanas de tratamiento.
9. Después de 8 semanas de tratamiento.

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

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

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

Argentina

Brazil

Colombia

Dominican Republic

Ecuador

Guatemala

Mexico

Panama

Peru

Philippines

Russian Federation

Slovakia

South Africa

Spain

Thailand

Vietnam

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

LVLV.

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)

Yes

F.1.2.1

Number of subjects for this age range:

1100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

286

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

156

F.4.2.2

In the whole clinical trial

1386

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)

An open-label extension study is planned. It is estimated that 600 male and female patients who successfully
complete the core study will enter this open-label extension study.

Se ha previsto una extensión con tratamiento abierto. Se estima que 600 pacientes (hombre y mujeres) que completaron la parte principal del estudio participarán en la extensión del ensayo con tratamiento abierto.

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

2013-08-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2014-06-24

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