Clinical Trials Register

Summary
EudraCT Number:	2016-002956-25
Sponsor's Protocol Code Number:	MAS-OLE-16-003
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:	2020-10-06
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

2016-002956-25

A.3

Full title of the trial

Olevia for the prevention of atrial fibrillation post heart valve-surgery.

OLEVIA per la prevenzione della fibrillazione atriale post-operatoria nei pazienti sottoposti a chirurgia valvolare cardiaca.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

MAS-OLE-16-003

A.5.4

Other Identifiers

Name:

MAS-OLE-16-003

Number:

MAS-OLE-16-003

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
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	IBSA FARMACEUTICI
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	FONDAZIONE POLICLINICO GEMELLI
B.5.2	Functional name of contact point	CARDIOCHIRURGIA
B.5.3	Address:
B.5.3.1	Street Address	L.GO GEMELLI 8
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630154639
B.5.5	Fax number	0630154108
B.5.6	E-mail	massimo.massetti@unicatt.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	OMEGAIBSA2 - 1000 MG CAPSULA MOLLE 2X10 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
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	OLEVIA
D.3.2	Product code	ND
D.3.4	Pharmaceutical form	Capsule, soft
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	ACIDI OMEGA 3
D.3.9.2	Current sponsor code	ND
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	3000
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, soft
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

POST-OPERATIVE ATRIAL FIBRILLATION

FIBRILLAZIONE ATRIALE POSTOPERATORIA

E.1.1.1

Medical condition in easily understood language

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	LLT
E.1.2	Classification code	10016566
E.1.2	Term	Fibrillation atrial
E.1.2	System Organ Class	100000004849

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 evaluate the antiarrhythmic effect of Olevia as add-on to standard therapy in patients undergoing heart valve surgery.

Valutare il ruolo anti-aritmico di Olevia in aggiunta alla terapia standard in pazienti sottoposti a chirurgia valvolare cardiaca.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Informed consent signed before starting any procedure provided by the study;
• age = 18 years;
• candidates for heart valve surgery;
• Sinus rhytm on ECG performed at pre-hospedalization time (with or not history of atrial fibrillation).
• Sexual abstinence for two months for male patients.

• Consenso Informato firmato prima dell’inizio di qualsiasi procedura prevista dallo studio
• Età = 18 anni
• Candidati a chirurgia valvolare cardiaca
• Ritmo sinusale all’ECG eseguito in fase di preospedalizzazione (con storia negativa o positiva per FAP)
• Astinenza da rapporti sessuali per due mesi per i pazienti di sesso maschile

E.4

Principal exclusion criteria

• Treatment ongoing with Olevia (hypertriglyceridemia, post-ischemic heart attack) at the time of enrollment;
• controindications to Olevia and excipiens;
• indication to combined heart valve surgery and coronary artery bypass surgery
• impaired liver function (transaminase 1,5 times the upper reference limit );
• impaired renal function (serum creatinine =2.5 mg/dl);
• pregnancy, breast-feeding, women in childbearing age;
• blood dyscrasias (anemias with HB <10 g/dl, myelodysplastic syndromes,myeloproliferative syndromes) thrombocytopenia.
• gastrointestinal inflammatory diseases;
• autoimmune diseases;
• hypersensivity to the active substance or to soya lecithin or to any of the excipients;
• patients unable to give informed consent.

• Trattamento con Olevia (ipertrigliceridemia, post-infarto) già in atto al momento dell’arruolamento
• Controindicazioni ad Olevia ed eccipienti
• Indicazione ad intervento combinato di chirurgia valvolare e bypass aorto-coronarico
• Alterata funzionalità epatica (valore di transaminasi 1,5 volte maggiore del limite superiore di riferimento)
• Alterata funzionalità renale (creatinina plasmatica =2.5 mg/dl)
• Gravidanza, allattamento, donne in età fertile
• Discrasie ematiche (anemie con HB <10 g/dl, sindromi mielodisplastiche, sindromi mieloproliferative) piastrinopenia con piatrine < 150.000/microlitro,• Malattie gastro-intestinali infiammatorie
• Malattie autoimmuni
• Ipersensibilità al principio attivo o alla lecitina di soia o ad uno qualsiasi degli eccipienti
• Pazienti incapaci di dare un consenso informato

E.5 End points

E.5.1

Primary end point(s)

Reduction in the incidence of atrial fibrillation in patients undergone surgical operation for valve disease and treated with Olevia 1000 mg per os three times daily in addition to standard therapy for 30 days before cardiac surgery.

Riduzione dell’incidenza di fibrillazione atriale post-operatoria in pazienti sottoposti a chirurgia valvolare cardiaca in trattamento con Olevia 1000 mg per os 3 volte al giorno in aggiunta alla terapia standard nei 30 giorni precedenti l’intervento chirurgico.

E.5.1.1

Timepoint(s) of evaluation of this end point

35 DAYS

35 GIORNI

E.5.2

Secondary end point(s)

¿ Safety of experimental drug
¿ Evaluation of reduction of laboratory inflammatory markers (GB, VES,PCR)
¿ Evaluation of the effect of Olevia in post-operative atrial and ventricular remodeling in patients that at the time of randomization have an echocardiogram performed until six months before the date of signing informed consent

Sicurezza del prodotto in studio.
- Valutazione della riduzione degli indici di flogosi (GB, VES,PCR).
- Valutazione del ruolo di Olevia nel rimodellamento atriale e ventricolare post-operatorio nei pazienti che al momento della randomizzazione abbiano eseguito un ecocardiogramma color doppler nei 6 mesi precedenti alla data di firma del Consenso Informato.

E.5.2.1

Timepoint(s) of evaluation of this end point

35 DAYS

35 GIORNI

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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)

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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:

140

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

152

F.4.2

For a multinational trial

F.4.2.1

In the EEA

152

F.4.2.2

In the whole clinical trial

152

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)

STANDARD OF CARE

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

2016-11-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-17

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

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