Clinical Trials Register

Summary
EudraCT Number:	2012-001100-38
Sponsor's Protocol Code Number:	FARM97AJNN
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-04-15
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-001100-38

A.3

Full title of the trial

Antagonists of Angiotensin II Receptors in sepsis

Antagonisti dei recettori dell'angiotensina II nella sepsi

A.3.1

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

Evaluation of the effect of the drugs that are antagonists of angiotensin II receptors in sepsis

Valutazione dell'effetto dei farmaci antagonisti dei recettori della angiotensina II sulla sepsi

A.4.1

Sponsor's protocol code number

FARM97AJNN

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01992796

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	DIPART. DI NEUROSCIENZE, SCIENZE RIPRODUTTIVE E ODONTOSTOMATOLOGICHE DELL’UNIVERSITà DEGLI STUDI DI NAPOLI “FEDERICO II"
B.1.3.4	Country	Italy
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	Italian Medicines Agency
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CD PHARMA GROUP SRL
B.5.2	Functional name of contact point	B.U. CRO
B.5.3	Address:
B.5.3.1	Street Address	PIAZZA DE ANGELI, 7
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20146
B.5.3.4	Country	Italy
B.5.4	Telephone number	+ 39 0289051076
B.5.5	Fax number	+ 390289051088
B.5.6	E-mail	simona.manzi@cdpharma.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	RETENSIR
D.2.1.1.2	Name of the Marketing Authorisation holder	GENETIC S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	IRBESARTAN
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Nasogastric use (Noncurrent) Oral use Buccal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IRBESARTAN
D.3.9.1	CAS number	138402-11-6
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	75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	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

SEPSIS

SEPSI

E.1.1.1

Medical condition in easily understood language

Severe infection with generalized consequences for the organism

Infezione grave con conseguenze generalizzate sull'organismo

E.1.1.2

Therapeutic area

Not possible to specify

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10040047
E.1.2	Term	Sepsis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Verify if the administration of Irbesartan reduce the mortality rate in the subject with sepsis and verify the incidence of the related multiple organ failure (MOF) after 28 days from the onset of sepsis

Verificare se la somministrazione di Irbesartan riduce il tasso di mortalità nel soggetto con sepsi e l’incidenza della correlata sindrome di disfunzione d’organo multipla (MODS) a 28 giorni dall’esordio della sepsi.

E.2.2

Secondary objectives of the trial

Evaluation of the safety and the tolerability of a low dose of irbesartan in patients with sepsis

Valutazione della sicurezza e della tollerabilità di un regime a basso dosaggio di Irbesartan nei pazienti affetti da sepsi

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients with severe sepsis, hospitalised in the Intensive Care Unit, but able to give the informed consent; Female and Male; Age between 18 and 75 years old; sepsis evaluated wth the publications of the American College of Chest Physician/Society of Critical Care Medicine; multiple organ failure measured by SOFA (Sequential Organ Failure Assessment) score

Pazienti affetti da sepsi ma in grado di fornire il proprio esplicito consenso allo studio, ricoverati presso le Unità di Terapia Intensiva (UTI); soggetti di sesso femminile o maschile di età compresa tra 18 e 75 anni; diagnosi di sepsi effettuata con i pubblicati dell’American College of Chest Physician/Society of Critical Care Medicine. Presenza di disfunzione d’organo sarà valutata sulla base delle variabili cliniche e di laboratorio del Sequential Organ Failure Assessment (SOFA).

E.4

Principal exclusion criteria

Pregnancy; nursing; pre-existen renal damage (severe renal failure or creatinine value of 2,0 mg/dL or dialysis); patient in treatment with ACE inhibitors or ARBs; shock conditions (systolic blood pressure lower than 90 mmHg): patients inserted, in the previous 12 weeks, in another clinical trial that uses another farmaceutical product; known allergies to ARBs

Pazienti di sesso femminile che siano in gravidanza al momento dell’inclusione nel protocollo; coloro che presentano danno renale preesistente (grave insufficienza renale o creatinina di 2,0 mg / dL o dialisi); pazienti già in trattamento con ACE inibitori o ARBs; pazienti in condizioni di shock (pressione sistolica inferiore a 90 mmHg); pazienti reclutati in un altro studio che interessa un altro prodotto farmaceutico nelle precedenti 12 settimane; pazienti con allergie note ai sartanici

E.5 End points

E.5.1

Primary end point(s)

Verify if the administration of Irbesartan reduce the mortality rate in the subject with sepsis and verify the incidence of the related multiple organ failure (MOF)

Verificare se la somministrazione di Irbesartan riduce il tasso di mortalità nel soggetto con sepsi e l’incidenza della correlata sindrome di disfunzione d’organo multipla (MODS)

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 giorni

E.5.2

Secondary end point(s)

Evaluation of the safety and the tolerability of a low dose of irbesartan in patients with sepsis

Valutazione della sicurezza e della tollerabilità di un regime a basso dosaggio di Irbesartan nei pazienti affetti da sepsi

E.5.2.1

Timepoint(s) of evaluation of this end point

28 days

28 giorni

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

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Ultima visita dell'ultimo paziente arruolato nello Studio

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:

240

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-04-15.

Yes

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

Yes

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

300

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)

The patients at the end of the Clinical Trial will be followed in according to the Good Clinical Practice

Essendo uno studio di FASE III, che prevede un periodo di follow-up fino a 3 mesi dall'inclusione nello studio, i pazienti al termine dello stesso continueranno ad essere monitorati come da normale pratica clinica

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

2014-06-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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