Clinical Trials Register

Summary
EudraCT Number:	2006-006066-42
Sponsor's Protocol Code Number:	CSPA100A2303
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:	2008-09-29
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

2006-006066-42

A.3

Full title of the trial

Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, de ocho semanas de seguimiento, para evaluar la eficacia y seguridad de la combinación de aliskiren / amlodipino (300/5 mg y 300/10 mg) en comparación con aliskiren 300 mg, en pacientes con hipertensión esencial que no responden adecuadamente a la monoterapia con aliskiren 300 mg

A.4.1

Sponsor's protocol code number

CSPA100A2303

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Farmaceutica 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	SPA100
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	aliskiren
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	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	amlodipine
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT
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.3.2	Product code	SPA100
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	aliskiren
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	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	amlodipine
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	aliskiren
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	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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT

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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hipertensión

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demostrar la eficacia de las terapias combinadas de aliskiren/amlodipino (300mg/5 mg y 300/10 mg) en pacientes con hipertensión cuya presión arterial no responde satisfactoriamente al tratamiento de 4 semanas con aliskiren 300 mg comprobando la hipótesis de una reducción superior de la presión arterial diastólica media en sedestación (PADms) desde la visita basal hasta el final del estudio, en comparación con la monoterapia de aliskiren 300 mg.

E.2.2

Secondary objectives of the trial

? Evaluar la eficacia de las terapias combinadas de aliskiren/amlodipino (300mg/5 mg y 300/10 mg) en pacientes con hipertensión que no responden adecuadamente al tratamiento de 4 semanas con aliskiren 300 mg en comparación con la monoterapia de aliskiren 300 mg.
? Evaluar la seguridad (incluyendo edema) y la tolerabilidad de las combinaciones de aliskiren/amlodipino (300mg/5 mg y 300/10 mg) en comparación con la monoterapia de aliskiren 300mg en pacientes con hipertensión que no muestran una respuesta adecuada en la presión arterial al tratamiento de 4 semanas con aliskiren 300 mg.
? Evaluar la proporción de pacientes en los que se consigue el objetivo de control de la presión arterial de < 140 / 90 mmHg al final del estudio en todos los grupos de tratamiento.
Se exponen los principales objetivos secundarios. Para más detalles, remitirse al protocolo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Pacientes ambulatorios de 18 años de edad o mayores.
Pacientes hombres o mujeres elegibles.
Pacientes con diagnóstico de hipertensión:
Pacientes recién diagnosticados o pacientes que no han sido tratados para la hipertensión dentro de las 4 semanas previas a la Visita 1 deben presentar una PADms ? 95 mmHg y < 110 mmHg en las Visitas 1 y 2.
Pacientes que han recibido tratamiento para la hipertensión dentro de las 4 semanas previas a la Visita 1 deben presentar una PADms ? 90 mmHg y < 110 mmHg en la Visita 2.
Todos los pacientes deben presentar una PADms ? 90 mmHg y < 110 mmHg en la Visita 4.
Pacientes que sean elegibles y que puedan participar en el estudio, y que otorguen su consentimiento para participar en el mismo después de que se les haya explicado claramente el propósito y la naturaleza del estudio (consentimiento informado por escrito).

E.4

Principal exclusion criteria

Para encontrar la lista completa, remitirse al protocolo.

Pacientes previamente tratados en un estudio con aliskiren en el que estuviese incluido el grupo de tratamiento correspondiente a la combinación de aliskiren y amlodipino, y que hubiesen sido aleatorizados o reclutados en el período de tratamiento con fármaco activo de ese estudio.
? Hipertensión severa (PADms ?110 mmHg y/o PASms ? 180 mmHg).
? Mujeres embarazadas o en período de lactancia, donde el embarazo se define como el estado de una mujer tras la concepción y hasta el final de la gestación, confirmado mediante resultado positivo en la prueba de hCG realizada en laboratorio (? 5 mIU/ml).
? Mujeres en edad fértil (WOCBP), definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, incluidas las mujeres cuya carrera profesional, estilo de vida u orientación sexual excluya el coito con un varón, y mujeres cuyas parejas hayan sido esterilizados mediante vasectomía u otros métodos, A NO SER QUE estén utilizando dos métodos anticonceptivos. Los dos métodos pueden ser un método de doble barrera (si el comité ético local lo acepta) o un método de barrera junto con un método hormonal.
? Los métodos anticonceptivos de barrera adecuados incluyen: diafragma, preservativo (utilizado por la pareja), dispositivo intrauterino (cobre u hormonal), esponja o espermicida. Los anticonceptivos hormonales incluyen cualquier anticonceptivo comercializado que contenga un estrógeno y/o un progestágeno.
o El uso de métodos anticonceptivos fiables se debería mantener durante todo el estudio y durante 7 días después del estudio.
? Se considera que una mujer es posmenopáusica y no fértil si lleva 12 meses de amenorrea natural (espontánea) con un perfil clínico apropiado (p. ej., edad apropiada, antecedentes de síntomas vasomotores) o seis meses de amenorrea espontánea con niveles de FSH séricos > 40 mIU/ml [únicamente en EEUU: y estradiol <20 pg/ml] o ha sido sometida a ooforectomía bilateral quirúrgica (con o sin histerectomía) al menos seis semanas antes. Si sólo se ha realizado ooforectomía, en tal caso será necesario confirmar el estado reproductivo de la mujer mediante el seguimiento de la evaluación del nivel hormonal.
? Antecedentes o indicios de una forma secundaria de hipertensión.
? Retinopatía hipertensiva de grado III o IV de Keith-Wagener conocida
? Algún antecedente de encefalopatía hipertensiva o accidente cerebrovascular, o antecedentes de accidente isquémico transitorio (AIT), infarto de miocardio, derivación aortocoronaria, o cualquier intervención coronaria percutánea (ICP) dentro de los 12 meses previos a la Visita 1.

E.5 End points

E.5.1

Primary end point(s)

La variable de eficacia principal es el cambio desde la basal (Visita 4) en la presión arterial diastólica media (PADms) en sedestación. El momento del análisis principal es el final del estudio utilizando la extrapolación de la última observación (LOCF) (según se define en el Apartado 10.4.3) y al que se hace referencia como la medición al final del estudio.

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.1.7.1

Other trial design description

Non responder

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

Yes

E.8.2.3.1

Comparator description

aliskiren

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

Information not present in EudraCT

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	50
F.4.2	For a multinational trial
F.4.2.1	In the EEA	480
F.4.2.2	In the whole clinical trial	726

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

2008-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-11-13

P. End of Trial
P.	End of Trial Status	Completed

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