Clinical Trials Register

Summary
EudraCT Number:	2014-005378-12
Sponsor's Protocol Code Number:	CL3-05153-006
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-09-01
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-005378-12

A.3

Full title of the trial

Efficacy and Safety of Fixed-Dose Combination
atorvastatin / amlodipine / perindopril versus Fixed-Dose Combination of atorvastatin / amlodipine in Patients with Hypertension and Dyslipidemia.

Efficacy and Safety of Fixed-Dose Combination
atorvastatin/amlodipine/perindopril versus Fixed-Dose Combination of
atorvastatin/ amlodipine in Patients with Hypertension and Dyslipidemia.

A.3.1

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

Efficacy and Safety of Fixed-Dose Combination
atorvastatin / amlodipine / perindopril versus Fixed-Dose Combination of atorvastatin / amlodipine in Patients with Hypertension and Dyslipidemia.

Efficacia e sicurezza dell¿associazione a dose fissa di atorvastatina / amlodipina / perindopril versus l¿associazione a dose fissa di atorvastatina / amlodipina in pazienti con ipertensione e dislipidemia

A.3.2

Name or abbreviated title of the trial where available

Not available

Non disponibile

A.4.1

Sponsor's protocol code number

CL3-05153-006

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1166-2705

A.5.4

Other Identifiers

Name:

Number:

CL3-05153-006

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	INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
B.1.3.4	Country	France
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	ADIR
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ISTITUTO DI RICERCA SERVIER S.R.L.
B.5.2	Functional name of contact point	Project Manager Sabrina Ceccotti
B.5.3	Address:
B.5.3.1	Street Address	Via Luca Passi, 85
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00166
B.5.3.4	Country	Italy
B.5.4	Telephone number	06669081
B.5.5	Fax number	0666908738
B.5.6	E-mail	infoirs@netgrs.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	Triveram
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoires Servier
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PERINDOPRIL
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB23191
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Yes
D.2.1.1.1	Trade name	Triveram
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoire Servier
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PERINDOPRIL
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB23191
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Triveram
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoire Servier
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PERINDOPRIL
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB23191
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	CADUET
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ILACLARI LTD. STI
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.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	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	CADUET
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ILACLARI LTD. STI
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.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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: 6
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	CADUET
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER AUSTRALIA PTY LTD
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.3.4	Pharmaceutical form	Capsule, hard
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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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: 7
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	CADUET
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER KOREA
D.2.1.2	Country which granted the Marketing Authorisation	Korea, Republic of
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	Capsule, hard
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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	NA
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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: 8
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	CADUET
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Malaysia
D.2.1.2	Country which granted the Marketing Authorisation	Malaysia
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	Capsule, hard
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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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: 9
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	CADUET
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Corporation Austria Ges.m.b.H., Wien
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	Capsule, hard
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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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: 10
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	CADUET
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Korea
D.2.1.2	Country which granted the Marketing Authorisation	Korea, Republic of
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	Capsule, hard
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	ATORVASTATINA
D.3.9.1	CAS number	134523-03-8
D.3.9.2	Current sponsor code	ND
D.3.9.4	EV Substance Code	SUB12958MIG
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMLODIPINA
D.3.9.2	Current sponsor code	ND
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Capsule, hard
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

Hypertension and dyslipidemia

Ipertensione e dislipidemia

E.1.1.1

Medical condition in easily understood language

Hypertension and dyslipidemia

Ipertensione e dislipidemia

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	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10020774
E.1.2	Term	Vascular hypertensive disorders NEC
E.1.2	System Organ Class	100000004866

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10058110
E.1.2	Term	Dyslipidemia
E.1.2	System Organ Class	100000004861

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 demonstrate the superiority of oral fixed-dose combination atorvastatin/amlodipine/perindopril versus the reference drug atorvastatin/amlodipine in lowering office sitting systolic blood pressure (SBP) after 12 weeks of treatment (W012) versus baseline (W012-W000).

Dimostrare la superiorit¿ del trattamento orale a dose fissa dell'associazione atorvastatina / amlodipina / perindopril versus il farmaco di riferimento atorvastatina / amlodipina nel ridurre la pressione sistolica arteriosa (SBP) ambulatoriale in posizione seduta dopo 12 settimane di trattamento (visita W012) rispetto alla misurazione baseline (W012-W000)

E.2.2

Secondary objectives of the trial

-To assess the efficacy of atorvastatin / amlodipine / perindopril versus atorvastatin / amlodipine in lowering Diastolic Blood Pressure (DBP) after 12 weeks of treatment versus baseline (W012-W000).
-To assess the efficacy of atorvastatin/ amlodipine/ perindopril in lowering Low Density Lipoprotein-Cholesterol (LDL-c) after 12 weeks of treatment versus baseline (W012-W000) within group
-To assess the safety of each dose of atorvastatin/ amlodipine/ perindopril during the study and at the end of the treatment period (W012).

-Verificare l¿efficacia dell' associazione atorvastatina /amlodipina/ perindopril versus atorvastatina /amlodipina nel ridurre la pressione diastolica arteriosa (DBP) dopo 12 settimane di trattamento rispetto alla misurazione baseline (W012-W000)
-Verificare l¿efficacia dell'associazione atorvastatina /amlodipina/ perindopril nel ridurre il Colesterolo ¿Lipoproteine a bassa Densit¿ (LDL-c) dopo 12 settimane di trattamento rispetto alla baseline (W012-W000) ,
-Verificare la sicurezza di ciascuna dose dell'associazione atorvastatina / amlodipina / perindopril durante lo studio e alla fine del periodo di trattamento (W012).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1-Men or women of any ethnic origin aged 40 to 79 years inclusive who have signed the informed consent form and can comply with the study requirements and timetable.
2-Essential hypertension defined as: Hypertensive patients naïve of treatment with 160 mmHg = SBP <180 mmHg and 100 mmHg = DBP < 110 mmHg or isolated systolic hypertension (160 mmHg = SBP <180 mmHg) or
Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril 10mg or amlodipine 10mg) for combined systolic and diastolic hypertension (150 mmHg = SBP < 180 mmHg and 95 mmHg = DBP < 110 mmHg) or isolated systolic hypertension (150 mmHg = SBP < 180 mmHg)
3-Dysplipidemic patients : naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 130 mg/ Decilitre (dL) (or 3.36 millimole [mmol] /L) = LDL-c < 190 mg/dL (or 4.91 mmol/L) according to a prevous laboratory result within 12 months
4-Confirmed hypertension measured at inclusion: 150 mmHg = SBP < 180 mmHg and 95 mmHg = DBP < 110 mmHg or isolated systolic hypertension 150 mmHg = SBP < 180 mmHg for either patients under prior monotherapy treatment or patients naive of treatment
5-Confirmed dyslipidemia on lipid profile assessed at W0 visit: 130 mg/dL = LDL-c < 190 mg/dL

1-Uomini o donne di qualunque origine etnica con età compresa tra 40 e 79 anni inclusi, che hanno firmato il consenso informato e che rispettano i criteri e la tempistica dello studio
2-Ipertensione essenziale definite come:
- Pazienti ipertesi naïve al trattamento con 160 mmHg = SBP <180 mmHg e 100 mmHg = DBP < 110 mmHg o ipertensione sistolica isolata (160 mmHg = SBP <180 mmHg) oppure
- Pazienti ipertesi non controllati e in trattamento, con monoterapia da almeno 4 settimane (eccetto pazienti trattati con perindopril 10mg o amlodipine 10mg) con ipertensione sistolica e diastolica combinata (150 mmHg = SBP < 180 mmHg e 95 mmHg = DBP< 110 mmHg) o ipertensione sitolica isolata (150 mmHg = SBP< 180 mmHg), e
3-Pazienti dislipidemici: naïve al trattamento o non controllati con statina alla dose più bassa da almeno 4 settimane con un valore 130 mg/dL (o 3.36 mmol /L) = LDL-c< 190 mg/dL (o 4.91 mmol/L) come evidenziato da precedenti risultati di laboratorio ottenuti entro i 12 mesi
4-Conferma dell’ipertensione misurata alla visita W000 come: 150 mmHg = SBP< 180 mmHg e 95 mmHg = DBP< 110 mmHg oppure ipertensione sitolica isolata 150 mmHg = SBP < 180 mmHg sia per i pazienti in trattamento monoterapico che per quelli naive al trattamento
5-Conferma della dislipidemia con verifica del profilo lipidico valutato alla visita W000 come: 130 mg/dL=LDL-c< 190 mg/dL

E.4

Principal exclusion criteria

1-Known symptomatic orthostatic hypotension
2-Secondary hypertension
3-Isolated diastolic hypertension defined as DBP > or = 90 mmHg
4-Known complicated hypertension: known stage III or IV hypertensive retinopathy, microalbuminaria
5-Known diabetes mellitus type I or type II
6-Obesity defined as a body mass index = 32 kg/m2
7-History or current presence of lymphedema or leg edema (unilateral or bilateral) of venous origin: previously known or discovered during the clinical examination at the selection visit, due to but not limited to calcium channel blockers, especially amlodipine (which induced amlodipine dose down titration or treatment stop)
8-Any history of stroke, transient ischemic attack, cerebrovascular surgery or history of coronary artery disease; heart failure (New York Heart Association [NYHA] II-IV), or hypertrophic obstructive myocardiopathy; unstable angina
9-Known ventricular rhythm disorders (except premature ventricular extrasystole less frequent than 6/minute); history of atrial fibrillation or atrial flutter (except if cured e.g. ablation without no new episodes within the last 12 months) or second or third degree A-V block or other cardiac rhythm disorders leading to important beat to beat variations in blood pressure or known valvular diseases (except mitral valve prolapse)
10-Known renal impairment moderate or severe (known creatinine clearance <60 mL/mn), or bilateral renal artery stenosis or stenosis to a solitary kidney
11-Contraindications to calcium channel inhibitors and/or to ACE inhibitors and/or to statins and especially: known allergy/hypersensitivity/history of intolerance, muscular toxicity during a treatment with a statin, hereditary or idiopathic angioedema, or history of angioedema associated with previous ACE inhibitor therapy
12-Any other medication which may be used for the treatment of hypertension, but which is currently being taken by the patient for an alternative indication, and which cannot be discontinued at the selection visit
13-History of myopathy, familial history of hereditary muscular disorders

1-Ipertensione ortostatica sintomatica nota
2-Ipertensione secondaria
3-Ipertensione diastolica isolata definita come DBP= 90 mmHg
4-Storia di ipertensione complicata come: conosciuta retinopatia ipertensiva di grado III o IV, microalbuminuria
5-Storia di diabete mellito di tipo I o tipo II
6-Obesità definita come indice di massa corporea = 32 kg/m2
7-Storia conosciuta o presenza attuale di linfoedema o edema alle gambe (unilaterale o bilaterale) di origine venosa: conosciuta precedentemente o scoperta durante l’esame clinico nella visita di selezione, dovuto ad amlodipina o a qualunque farmaco che blocca i canali del calcio, e che ha indotto la diminuzione del dosaggio di amlodipina o interruzione del trattamento
8-Storia di ictus, attacchi ischemici transienti, chirurgia cerebrovascolare o storia di malattia arterica coronarica; scompenso cardiaco (New York Heart Association [NYHA] II-IV), o miocardiopatia ipertrofica ostruttiva; angina instabile
9-Storia di disordini nel ritmo ventricolare (eccetto extrasistole prematura ventricolare con frequenza minore di 6/minuto); storia di flutter o fibrillazione atriale (a meno che sia stata curata con ad es. ablazione senza nuovi episodi entro gli ultimi 12 mesi) o blocco A-V di secondo o terzo grado o altri disordini del ritmo cardiaco che comportano significative variazioni beat-to-beat nella pressione arteriosa o malattie valvolari conosciute (eccetto prolasso della valvola mitrale)
10-Storia di disfunzioni renali moderate o gravi (valore di clearance creatinina <60 mL/mn), o stenosi bilaterale dell’arteria renale o stenosi dell arteria di rene unico
11-Controindicazioni per gli inibitori dei canali del calcio e/o agli ACE inibitori e/o a statine ed in particolare: conosciute allergie /ipersensibilità/ intolleranze, tossicità muscolare durante un trattamento con una statina, angioedema ereditario o idiopatico, o storia di angioedema associato a precedenti terapie con ACE inibitori
12-Qualsiasi altro farmaco usato per il trattamento dell’ipertensione, ma che è attualmente assunto dal paziente per un'altra indicazione che non può essere interrotto alla visita di selezione
13-Storia di miopatie, storia di disordini familiari muscolari ereditari

E.5 End points

E.5.1

Primary end point(s)

Office sitting Sistolic blood pressure( SBP) measured within 24 ± 3 hours after the last drug intake in the Investigator’s office using an automated validated device

SBP misurata in posizione seduta nel centro sperimentale entro 24 ± 3 ore dopo l’ultima assunzione del farmaco in studio usando un dispositivo automatizzato validato

E.5.1.1

Timepoint(s) of evaluation of this end point

All visits (W000,W004 e W012)

Tutte le visite (W000,W004 e W012)

E.5.2

Secondary end point(s)

Efficacy. Office sitting DBP measured within 24 ¿ 3 hours after the last drug intake in the Investigator¿s office using an automated validated device; Efficacy. Change from baseline over 12 weeks in LDL-c, total cholesterol, high density lipoprotein-c (HDL-c), and triglycerides; Safety. Adverse events; Safety. Vital signs including BP postural changes ; Safety. Clinical laboratory parameters (biochemistry and haematology); Safety. Electrocardiogram (ECG)

Efficacia. DBP misurata in posizione seduta nel centro sperimentale entro 24 ¿ 3 ore dopo l¿ultima assunzione del farmaco in studio usando un dispositivo automatizzato validato; Efficacia. Differenza dei valori di LDL-c, colesterolo totale, HDL-c e trigliceridi alla visita W012 paragonati alla visita iniziale di selezione.; Sicurezza. Eventi Avversi; Sicurezza. Segni vitali inclusi i cambiamenti di BP posturale; Sicurezza. Parametri clinici di laboratorio (biochimica ed ematologia); Sicurezza. Elettrocardiogramma (ECG)

E.5.2.1

Timepoint(s) of evaluation of this end point

All visits (W000, W004 e W012); Inclusion W004 and W012; All visits; All visits; At W004; Inclusion and W012

Tutte le visite (W000, W004 e W012); Inclusione W004 e W012; Tutte le visite; Tutte le visite; Alla W004; Inclusione e W012

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

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

Brazil

Korea, Republic of

Mexico

Russian Federation

Argentina

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:

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

180

F.4.2.2

In the whole clinical trial

700

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)

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

2015-03-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-29

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

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Clinical trials