Clinical Trials Register

Summary
EudraCT Number:	2012-003487-48
Sponsor's Protocol Code Number:	F373280CA201
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-04-11
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

Czechia - SUKL

A.2

EudraCT number

2012-003487-48

A.3

Full title of the trial

Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.

Studie účinnosti a bezpečnosti F373280 pro udržení sinusového rytmu po elektrické kardioverzi u pacientů s perzistující fibrilací síní a chronickým srdečním selháním.

A.3.1

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

Efficacy and safety study of F373280

Studie účinnosti a bezpečnosti F373280

A.4.1

Sponsor's protocol code number

F373280CA201

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	PIERRE FABRE MEDICAMENT
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	PIERRE FABRE MEDICAMENT
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	INSTITUT DE RECHERCHE PIERRE FABRE - Centre de R&D Pierre Fabre
B.5.2	Functional name of contact point	MARINE FAGARD
B.5.3	Address:
B.5.3.1	Street Address	INSTITUT DE RECHERCHE PIERRE FABRE - Centre de R&D Pierre Fabre - BP 13562 - 3 avenue Hubert Curien
B.5.3.2	Town/ city	TOULOUSE Cédex 1
B.5.3.3	Post code	31035
B.5.3.4	Country	France
B.5.4	Telephone number	0033(0)5 34 50 63 54
B.5.5	Fax number	0033(0)5 34 50 65 92
B.5.6	E-mail	marine.fagard@pierre-fabre.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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	panthenyl ester of DHA
D.3.2	Product code	F373280
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	panthenyl ester of DHA
D.3.9.2	Current sponsor code	F373280
D.3.9.3	Other descriptive name	DOCOSAHEXAENOIC ACID PANTHENYL ESTER
D.3.9.4	EV Substance Code	SUB33358
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	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

F373280 is a new therapy based on DHA delivery (pro-drug) developed for the maintenance of sinus rhythm after electrical cardioversion in persistent atrial fibrillation (AF) patients with chronic heart failure.
The results of a pharmacological study performed in animals evidenced that DHA reduces the duration of Atrial Fibrillation (AF) induced by burst pacing.

E.1.1.1

Medical condition in easily understood language

F373280 is a new therapy based on DHA delivery developed for the maintenance of sinus rhythm after electrical cardioversion in persistent atrial fibrillation patients with chronic heart failure.

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10003658
E.1.2	Term	Atrial fibrillation
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary:
Efficacy of F373280 on the maintenance of sinus rhythm after direct electrical cardioversion in patients with persistent atrial fibrillation and chronic heart failure

E.2.2

Secondary objectives of the trial

Secondary:
- Efficacy of F373280 on the efficiency of direct electrical cardioversion
- Effect of F373280 on echocardiographic parameters
- Safety and tolerability of F373280

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Demographic Characteristics and Other Baseline Characteristics:
1.Men or women aged more than 18 years (inclusive),
2.Patients with current persistent AF between 7 days and 6 months duration for whom electrical cardioversion is warranted.
3.Previous history of first documented episode of persistent AF.
4.Previous history of ischemic or non ischemic heart failure
5.NYHA class I or II chronic heart failure at selection and at inclusion
6.Left ventricular systolic disfunction defined at selection and at inclusion by a reduced left ventricular ejection fraction (LVEF) ≥ 30% and ≤ 45% or for patients with a LVEF > 45%:
•an increased left ventricular end-diastolic size (diameter ≥ 60 mm
and/or > 32 mm/m² and/or volume > 97 ml/m²)
•and/or an increased left ventricular end-systolic size
(diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²)
•and/or a reduced left ventricular outflow tract velocity time integral <
15 cm
7.On appropriate, stable medical treatments for heart failure, including a
diuretic and/or angiotensin-converting enzyme, and/or angiotensinreceptor
blocker and/or mineralocorticoid receptor (MR) antagonists,
and/or betablockers
8.Left atrial area ≤ 40 cm² at selection and at inclusion
9.Patients treated or having to be treated by vitamin K antagonist
10.For female patient of child-bearing potential:
•In all the countries except Italy:
-Use of an effective method of contraception (hormonal contraception or
intra-uterine device) assessed by the investigator, for at least 2 months
before the selection in the study, and agreement to go on using it during
the whole duration of the study and up to 1 month after the last dose of
the study treatment
-Documented as surgically sterilized
•In Italy only:
-Absolute abstention from sexual intercourse during the whole duration
of the study and for a month after the end of the study or
-Use of double barrier contraception method (use of effective medical
contraception method) from at least 2 months before the start of the
study to the entire duration of the study and for a month after the end of
the study or
-Documented as surgically sterilized
11.For female patient of child-bearing potential: negative urine
pregnancy test at inclusion
12.For male with a child-bearing potential partner (In Italy only):
-Absolute abstention from sexual intercourse during the whole duration
of the study and for 3 months after the end of the study or
-Use of double barrier contraception method (use of condom for male
and effective contraception method for the partner) from the entire
duration of the study to 3 months after the end of the study.
Ethical / legal considerations:
13.Having signed his/her written informed consent,
14.Affiliated to a social security system, or is beneficiary (if applicable in
the national regulation)

E.4

Principal exclusion criteria

Criteria related to pathologies:
1.No previous history of first documented episode of persistent AF
2.More than two successful cardioversions (electrical or
pharmacological) in the last 6 months
3.Secondary Atrial Fibrillation due to alcohol or severe valvular heart
disease (grade III to IV)
4.NYHA class III or IV heart failure at selection or at inclusion
5.Thyroid disease uncontrolled by treatment: TSH ± T4L ± T3L to be
checked in case of treatment for thyroid disease
6.Myocardial infarction or unstable angina or presence of unstable
ischemic coronaropathy assessed by coronarography or cardiac stress
test (Echo stress, exercise stress test, nuclear or MR perfusion
evaluation methods) within 6 months before selection
7.Severe chronic kidney disease (creatinine ≥ 25 mg/L or estimated
glomerular filtration rate < 30 ml/min) at selection
8.Bradycardia (HR ≤ 50 bpm)
9.Hyperkalemia or hypokalemia (according to the standards of local
laboratories) at selection
10.Cardiac surgery within 3 months before selection or planned during
the study duration
Criteria related to treatments:
11.Previously ineffective pharmacological or electrical cardioversion
12.Concomitant treatment with ranolazine or any antiarrhythmic drug
(within 7 days prior to selection), except amiodarone, dronedarone and
stable dose of digoxin, betablockers, calcium-blockers
13.Concomitant treatment with oral amiodarone or dronedarone from
selection
14.Concomitant treatment with intravenous amiodarone from selection
15.Patient requiring a cardiac resynchronization therapy (CRT) or having
undergone CRT implantation within the last 6 months
16.Treatment with any Polyunsaturated Fatty Acid (PUFA) within the last
3 months
17.Dietary supplement with ω 3 or ω 6 according to investigator's
judgement
18.Having undergone any form of ablation therapy for AF
19.Patient treated with oral anticoagulant treatment other than vitamin
K antagonist: new oral anticoagulants (dabigatran, rivaroxaban,
apixaban), or treated with irreversible antiplatelet agents P2Y12
inhibitors such as ticlopidine, clopidogrel or prasugrel
Other criteria:
20.Patient liable not to comply with protocol instructions and/or with
treatment, in the investigator's opinion
21.Patient having taken part in a clinical trial in the preceding 2 months
or taking part in a trial at the time of selection
22.Patient linguistically or mentally unable to understand the nature,
objectives and possible consequences of the trial, or refusing to patient
himself/herself to its constraints
23.Patient family member or work associate (secretary, nurse,
technician,..) of the Investigator
24.Patient having forfeited his / her freedom by administrative or legal
award or being under guardianship
25. Breastfeeding female patient

E.5 End points

E.5.1

Primary end point(s)

efficacy

E.5.1.1

Timepoint(s) of evaluation of this end point

Time to first Atrial Fibrillation recurrence or atrial flutter emergence defined by the time to first episode of AF or atrial flutter lasting for at least 10 minutes.

E.5.2

Secondary end point(s)

safety

E.5.2.1

Timepoint(s) of evaluation of this end point

Adverse events
Vital signs
Physical examination
Standard 12-lead ECG
Haematology
Biochemistry
Coagulation parameters

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)

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

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

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)

None

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

2013-06-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-04-03

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