Clinical Trials Register

Summary
EudraCT Number:	2007-002421-68
Sponsor's Protocol Code Number:	1235.6
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:	2007-11-21
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

2007-002421-68

A.3

Full title of the trial

Estudio con 3 brazos de tratamiento aleatorizado a doble ciego durante 8 semanas, para comparar la seguridad y eficacia de la combinación de telmisartán 40 mg+ amlodipino 10 mg versus telmisartán 80 mg + amlodipino 10 mg versus amlodipino 10 mg en monoterapia en pacientes con hipertensión que no responden adecuadamente al tratamiento con amlodipino 10 mg en monoterapia.

An eight-week randomised, 3-arm, double-blind study to compare the safety and efficacy of the combination of telmisartan 40mg + amlodipine 10mg versus
telmisartan 80mg + amlodipine 10mg versus amlodipine 10mg monotherapy in patients with hypertension who fail to respond adequately to treatment with
amlodipine 10mg monotherapy.

A.4.1

Sponsor's protocol code number

1235.6

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	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
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.3.1	Product name	telmisartan/amlodipino (40mg/10mg) combinación a dosis fija
D.3.2	Product code	T40/A10
D.3.4	Pharmaceutical form	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	telmisartan
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	40
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	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	telmisartan/amlodipino (80mg/10mg) combinación a dosis fija
D.3.2	Product code	T80/A10
D.3.4	Pharmaceutical form	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	telmisartan
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	80
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	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	Norvasc
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Norvasc
D.3.2	Product code	C08CA01
D.3.4	Pharmaceutical form	Capsule*
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	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	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
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule*
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 esencial

essential hypertension

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 que la combinación de telmisartán (40 u 80 mg) + amlodipino 10 mg (A10) es superior a la monoterapia con A10 para reducir la presión arterial diastólica (PAD) valle en sedestación en pacientes que no responden a monoterapia con A10.

To show that the combination of telmisartan (40 or 80mg) + amlodipine 10mg (A10) is superior to A10 monotherapy in reducing seated trough diastolic blood pressure (DBP) in patients who fail to respond to A10 monotherapy.

E.2.2

Secondary objectives of the trial

(i) demostrar que la combinación de telmisartán (40 u 80 mg) + A10 es superior a la monoterapia con A10 reduciendo la presión arterial sistólica (PAS) valle en sedestación en pacientes que no responden a monoterapia con A10. (ii) demostrar que la combinación de telmisartán (40 u 80 mg) + A10 es superior a la monoterapia con A10 reduciendo otras variables de presión arterial incluyendo el porcentaje de pacientes en quienes se obtiene control de la presión arterial, respuesta de la PAD y respuesta de la PAS, y los porcentajes de pacientes con presión arterial óptima, normal, alta-normal y alta y (iii) monitorizar la seguridad por medio de exploraciones físicas, parámetros analíticos, electrocardiogramas (ECG) de 12 derivaciones y notificaciones de acontecimientos adversos.
Se comparará la eficacia de la combinación de telmisartán 40 mg + amlodipino 10 mg (T40/A10) con la de la combinación de telmisartán 80 mg + amlodipino 10 mg (T80/A10) respecto a todos los criterios de valoración

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. edad igual o superior a 18 años en el momento de firmar el consentimiento informado.
2. diagnóstico de hipertensión esencial y presión arterial no controlada adecuadamente antes de firmar el consentimiento informado (control inadecuado que se define como una PAD en sedestación ≥ 95 mmHg si está tomando tratamiento antihipertensivo o una PAD en sedestación ≥ 100 mmHg si no está recibiendo tratamiento).
3. falta de respuesta al tratamiento de seis semanas con A10. (La falta de respuesta se define como una PAD en sedestación ≥ 90 mmHg a las seis semanas. Este criterio se evaluará en la visita 4).
4. posibilidad de suspender el tratamiento antihipertensivo habitual sin que ello suponga un riesgo inaceptable para el paciente.
5. buena disposición y capacidad de otorgar el consentimiento informado por escrito (conforme a la Buena Práctica Clínica y a la legislación local).

E.4

Principal exclusion criteria

1. embarazo, lactancia o mujeres en edad fértil que no utilicen un método anticonceptivo aceptable durante el estudio y no consientan en someterse a pruebas de embarazo durante su participación en el mismo.
2. PAS media en sedestación ≥ 200 mmHg y/o PAD media en sedestación ≥ 120 mmHg en la visita 1 o en cualquier momento durante el tratamiento de selección o PAS media en sedestación ≥ 180 mmHg y/o PAD media en sedestación ≥ 120 mmHg en la visita de aleatorización (la visita 4) o en cualquier momento durante el tratamiento aleatorizado.
3. cualquier disfunción hepática clínicamente significativa
4. disfunción renal grave, estenosis bilateral de la arteria renal o estenosis de la arteria de un único riñón funcional o tras trasplante renal.
5. hiperpotasemia clínicamente relevante.
6. depleción de volumen o de sodio no corregidas.
7. aldosteronismo primario.
8. intolerancia hereditaria a la fructosa o la lactosa.
9. insuficiencia cardíaca congestiva sintomática (clase funcional III-IV de la New York Heart Association).
10. pacientes con antecedentes de síntomas característicos de angioedema durante el tratamiento con IECAs o antagonistas de los receptores de la angiotensina II.
11. antecedentes de drogodependencia o alcoholismo durante los seis meses anteriores a la firma del formulario de consentimiento.
12. participación en otro ensayo clínico o toma de cualquier tratamiento en fase de investigación clínica durante los treinta días anteriores a la firma del consentimiento.
13. miocardiopatía hipertrófica obstructiva, estenosis hemodinámicamente significativa de la válvula aórtica o mitral.
14. hipersensibilidad alérgica conocida a cualquier componente de las formulaciones en estudio.
15. incumplimiento de pauta de medicación del estudio (que se define como inferior al 80% o superior al 120%) durante el período selección con tratamiento abierto.
16. tratamiento en la actualidad con cualquier antihipertensivo, ya sean prescritos o no para esta indicación, que no pueda interrumpirse con seguridad (decisión del investigador) al iniciar el tratamiento de selección.
17. administración crónica de cualquier medicación que altere la presión arterial distinta de la medicación del ensayo.
18. cualquier situación clínica que, a juicio del investigador, no permita la finalización segura del protocolo y la administración segura del telmisartán y el amlodipino.

E.5 End points

E.5.1

Primary end point(s)

El criterio de valoración principal es el cambio respecto a la situación basal de la PAD valle en sedestación (es decir, la PAD aproximadamente 24 horas después de la última dosis del tratamiento del estudio) al cabo de ocho semanas de tratamiento o en la última observación en el valle durante el período de tratamiento a doble ciego (es decir, la última observación valle considerada).

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

Yes

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.8.3

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.8.5

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

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

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Information not present in EudraCT

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

160

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1135

F.4.2.2

In the whole clinical trial

2296

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)

Se ofrecerá la posibilidad de participar en un estudio abierto de seguimiento o bien seguir con los cuidados habituales.

Will be offered participation in an open-label follow-up study or usual care

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

2007-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-10-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-10-17

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