Clinical Trials Register

Summary
EudraCT Number:	2018-004809-58
Sponsor's Protocol Code Number:	HEBRO-001
National Competent Authority:	Greece - EOF
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-02-21
Trial 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Greece - EOF

A.2

EudraCT number

2018-004809-58

A.3

Full title of the trial

Comparative study of eplerenone-based treatment strategy versus irbesartan-based blood pressure lowering in obese hypertensive patients (HEBRO Study)

Συγκριτική μελέτη της θεραπευτικής στρατηγικής βασιζόμενη στην επλερενόνη έναντι της βασιζόμενης στην ιρβεσαρτάνη για τη μείωση της αρτηριακής πίεσης σε παχύσαρκους υπερτασικούς ασθενείς (Μελέτη HEBRO)

A.3.1

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

Hypertension thErapy with irBesartan Versus epleRenone for Obese hypertensive patients: A Randomized Clinical Trial

Θεραπεία υπέρτασης με irBesartan έναντι epleRenone σε παχύσαρκους υπερτασικούς ασθενείς: Μια τυχαίοποιημένη κλινική δοκιμή

A.3.2

Name or abbreviated title of the trial where available

HEBRO

A.4.1

Sponsor's protocol code number

HEBRO-001

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	Institute for study, research, education and therapy of vascular, heart, brain and kidney nosologies (I.N.A.K.E.N)
B.1.3.4	Country	Greece
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Institute for study, research, education and therapy of vascular, heart, brain and kidney nosologies (I.N.A.K.E.N)
B.4.2	Country	Greece
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institute for study, research, education and therapy of vascular, heart, brain and kidney nosologies (I.N.A.K.E.N)
B.5.2	Functional name of contact point
B.5.3	Address:
B.5.3.1	Street Address	Mesogion Avenue, 38th-40th
B.5.3.2	Town/ city	Athens
B.5.3.3	Post code	11527
B.5.3.4	Country	Greece
B.5.4	Telephone number	+302130366381
B.5.6	E-mail	inaken.info@gmail.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	Yes
D.2.1.1.1	Trade name	Inosamin® 25mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Elpen Pharmaceutical Co. Inc.
D.2.1.2	Country which granted the Marketing Authorisation	Greece
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	EPLERENONE
D.3.9.3	Other descriptive name	EPLERENONE
D.3.9.4	EV Substance Code	SUB06574MIG
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	25
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	Lucidel® 150mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Elpen Pharmaceutical Co. Inc.
D.2.1.2	Country which granted the Marketing Authorisation	Greece
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	IRBESARTAN
D.3.9.3	Other descriptive name	IRBESARTAN
D.3.9.4	EV Substance Code	SUB08293MIG
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	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	Yes
D.2.1.1.1	Trade name	Amlopen® 5mg/cap
D.2.1.1.2	Name of the Marketing Authorisation holder	Elpen Pharmaceutical Co. Inc.
D.2.1.2	Country which granted the Marketing Authorisation	Greece
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
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	AMLODIPINE
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.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	Fludex® 1,5 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Servier Hellas
D.2.1.2	Country which granted the Marketing Authorisation	Greece
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	Coated 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	INDAPAMIDE
D.3.9.1	CAS number	26807-65-8
D.3.9.3	Other descriptive name	INDAPAMIDE
D.3.9.4	EV Substance Code	SUB08169MIG
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	1.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Amlopen® 5mg/cap
D.2.1.1.2	Name of the Marketing Authorisation holder	Elpen Pharmaceutical Co. Inc.
D.2.1.2	Country which granted the Marketing Authorisation	Greece
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
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	AMLODIPINE
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.IMP: 6
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	Fludex® 1,5 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Servier Hellas
D.2.1.2	Country which granted the Marketing Authorisation	Greece
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	Coated 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	INDAPAMIDE
D.3.9.1	CAS number	26807-65-8
D.3.9.3	Other descriptive name	INDAPAMIDE
D.3.9.4	EV Substance Code	SUB08169MIG
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	1.5
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary Hypertension and Obesity

Υπέρταση σε παχύσαρκους ασθενείς

E.1.1.1

Medical condition in easily understood language

Hypertension

Υπέρταση

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10020775
E.1.2	Term	Hypertension arterial
E.1.2	System Organ Class	100000004866

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparison of the eplerenone based antihypertensive therapeutic strategy against the irbesartan-based antihypertensive therapeutic strategy for the reduction of the 24-hour ambulatory blood pressure in obese hypertensive patients over a 24-week follow-up.

Η σύγκριση της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη σε επλερενόνη έναντι της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη στην ιρβεσαρτάνη όσον αφορά στη μείωση της 24 ωρης περιπατητικής αρτηριακής πίεσης σε παχύσαρκους υπερτασικούς ασθενείς σε διάστημα 24 εβδομάδων παρακολούθησης.

E.2.2

Secondary objectives of the trial

1. Comparison of the eplerenone based antihypertensive treatment strategy against the irbesartan-based antihypertensive therapeutic strategy to reduce 24-hour ambulatory blood pressure over 8 and 16 weeks of follow-up.
2. Comparison of the eplerenone-based antihypertensive therapeutic strategy against the irbesartan-based antihypertensive therapeutic strategy for reducing blood pressure in a 8, 16, and 24-week follow-up.
3. Comparison of the eplerenone-based antihypertensive treatment strategy against the irbesartan-based antihypertensive therapeutic strategy with respect to the blood pressure control rate over 8, 16 and 24 weeks of follow-up.

1. Η σύγκριση της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη σε επλερενόνη έναντι της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη στην ιρβεσαρτάνη όσον αφορά στη μείωση της 24 ωρης περιπατητικής αρτηριακής πίεσης σε διάστημα 8 και 16 εβδομάδων παρακολούθησης.
2. Η σύγκριση της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη σε επλερενόνη έναντι της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη στην ιρβεσαρτάνη όσον αφορά στη μείωση της αρτηριακής πίεσης ιατρείου σε διάστημα 8, 16 και 24 εβδομάδων παρακολούθησης.
3. Η σύγκριση της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη σε επλερενόνη έναντι της αντιυπερτασικής θεραπευτικής στρατηγικής βασιζόμενη στην ιρβεσαρτάνη όσον αφορά στο ποσοστό ρύθμισης της αρτηριακής πίεσης σε διάστημα 8, 16 και 24 εβδομάδων παρακολούθησης.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. 30-75 years of age
2. Untreated or never-treated arterial hypertension with office systolic blood pressure of 140-180 mmHg and/or diastolic blood pressure of 90-120 mmHg
3. Confirmation of arterial hypertension by 24-hour ambulatory blood pressure measurements of mean ambulatory systolic blood pressure over 130 mmHg and/or mean ambulatory diastolic blood pressure over 80 mmHg
4. Obesity, confirmed estimated by Body Mass Index (BMI) of 30-39.99 kg/m2
5. Ιnformed written consent

1. Ασθενής ηλικίας 30-75 ετών
2. Συστολική αρτηριακή πίεση (ΣΑΠ) ιατρείου 140-179mmHg ή/και Διαστολική Αρτηριακή Πίεση (ΔΑΠ) ιατρείου 90-119 mmHg
3. Μέση τιμή 24ωρης καταγραφής Συστολικής Αρτηριακής Πίεσης >130mmHg ή/και Μέση τιμή 24ωρης καταγραφής Διαστολικής Αρτηριακής Πίεσης >80mmHg
4. Παχύσαρκος ασθενής με BMI: 30-39,99kg/m2
5. Ενυπόγραφη συγκατάθεση από τον ασθενή μετά από ενημέρωση

E.4

Principal exclusion criteria

1. Participation in a clinical trial with an Investigational Product or an invasive device during the study or the last 6 months
2. Secondary arterial hypertension
3. Recent (<6 months) cardiovascular event :
- myocardial infarction,
- unstable angina
- stroke)
4. Type 1 diabetes mellitus
5. Heart failure with reduced ejection fraction (EF<40%)
6. Chronic kidney disease assessed by eGFR<45mL/min/1,73m2
7. Bilateral renal arteries stenosis
8. Patient with hyperkalaemia (> 5.5)
9. Hemodynamically significant valvular heart diseas
10. Addison’s disease
11. Pregnancy, planning to conceive or women of childbearing potential, not using effective contraception
12. Scheduled surgery or cardiovascular surgery over the next 6 months
13. Absolute contra-indication to any of the study drugs
14. Requirement for study drug for reason other than to treat hypertension, (eg, β-blockers for angina or aldosterone antagonists for heart failure)
15. Neoplasm under treatment (radiotherapy / chemotherapy / immunotherapy)
16. Patient with a contemporary systemic disease with a life expectancy less than the end of the study
17. Any situation which, in the judgment of the investigator, may adversely affect the efficacy and / or safety of the Investigational Product (alcohol abuse, drug use, mental retardation)
18. Patient treated with systemic corticosteroids at least 3 months prior to the the study screening
19. Patient receiving α-inhibitors with the exception of aflucosin and tamsulosin for prostatic symptoms

1. Συμμετοχή σε κλινική δοκιμή Υπό Έρευνα Φαρμακευτικού Προϊόντος (ΥΕΦΠ) ή επεμβατικής συσκευής κατά τη διάρκεια της μελέτης ή τους τελευταίους 6 μήνες
2. Ασθενής με δευτεροπαθή αρτηριακή υπέρταση
3. Ασθενής με ιστορικό εντός 6μήνου :
• Εμφράγματος μυοκαρδίου
• Ασταθούς στηθάγχης
• Αγγειακού εγκεφαλικού επεισοδίου
4. Ασθενής με σακχαρώδη διαβήτη τύπου 1
5. Ασθενής με συστολική καρδιακή ανεπάρκεια EF≤40%
6. Ασθενής με χρόνια νεφρική νόσο (eGFR<45mL/min/1,73m2)
7. Ασθενής με αμφοτερόπλευρη στένωση νεφρικών αρτηριών
8. Ασθενής με υπερκαλιαιμία (>5,5)
9. Ασθενής με αιμοδυναμικά σημαντική βαλβιδική καρδιακή νόσο
10. Ασθενής με νόσο Addison
11. Γυναίκα ασθενής σε κύηση ή λοχεία ή γυναίκα ασθενής που προγραμματίζει κύηση.
12. Προγραμματισμένη χειρουργική ή καρδιαγγειακή επέμβαση τους επόμενους 6 μήνες
13. Ασθενής με απόλυτη αντένδειξη σε οποιοδήποτε ΥΕΦΠ
14. Ασθενής που είναι αναγκαίο να λάβει φάρμακο της μελέτης για διαφορετικό λόγο
15. Ασθενής με νεοπλασία υπό θεραπεία (ακτινοθεραπεία, χημειοθεραπεία, ανοσοθεραπεία)
16. Ασθενής με σύγχρονη συστηματική νόσο με προσδόκιμο επιβίωσης μικρότερο από το πέρας της μελέτης
17. Οποιαδήποτε κατάσταση που κατά την κρίση του ερευνητή μπορεί να επηρρεάσει δυσμενώς την αποτελεσματικότητα ή/και την ασφάλεια των Υπό Έρευνα Φαρμακευτικών Προϊόντων (ΥΕΦΠ) (κατάχρηση αλκοολ, χρήση ναρκωτικών ουσιών, διανοητική υστέρηση)
18. Ασθενής που έχει λάβει θεραπεία με συστηματικά κορτικοστεροειδή τουλάχιστον 3 μήνες πριν την ένταξή του στη μελέτη
19. Ασθενής που λαμβάνει α-αναστολείς με εξαίρεση την αφλουζοσίνη και την ταμσουλοζίνη για τα προστατικά συμπτώματα

E.5 End points

E.5.1

Primary end point(s)

Reduction in 24-hour ambulatory blood pressure in the eplerenone-based treatment group and in the irbesartan-based treatment group at 24 weeks.

Η μείωση της 24ωρης περιπατητικής αρτηριακής πίεσης στο σκέλος της επλερενόνης έναντι του σκέλους της ιρβεσαρτάνης στις 24 εβδομάδες παρακολούθησης.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Εβδομάδα 24

E.5.2

Secondary end point(s)

1. Reduction in 24-hour ambulatory blood pressure in the eplerenone-based treatment group and in the irbesartan-based treatment group at 8 and 16 weeks.
2. Reduction in 24-hour ambulatory blood pressure in the eplerenone-based treatment group and in the irbesartan-based treatment group at 8 and 16 weeks.
3. Frequency of controlled hypertension in the eplerenone-based treatment group and in the irbesartan-based treatment group at 8, 16 and 24 weeks.

1. Η μείωση της 24ωρης περιπατητικής αρτηριακής πίεσης στο σκέλος της επλερενόνης έναντι του σκέλους της ιρβεσαρτάνης στις 8 και 16 εβδομάδες παρακολούθησης.
2.Η μείωση της αρτηριακής πίεσης ιατρείου σε διάστημα 8, 16 και 24 εβδομάδων παρακολούθησης.
3. Το ποσοστό ρύθμισης της αρτηριακής πίεσης σε διάστημα 8, 16 και 24 εβδομάδων παρακολούθησης.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Week 6 and week 16
2. Week 6 and week 16
3 . Week 6 , 16 and 24

1. Εβδομάδα 6 και εβδομάδα 16
2. Εβδομάδα 6 και εβδομάδα 16
3. Εβδομάδα 6 , 16 και 24

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)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

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

LVLS

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

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.1.3

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

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

340

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)

As per Standard of 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

2019-04-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-03-29

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials