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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2009-011819-20-FR |
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Date of registration:
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15/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of OMACOR in patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome. A proof of concept study.
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Scientific title:
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Effects of OMACOR in patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome. A proof of concept study.
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Date of first enrolment:
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29/05/2009 |
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Target sample size:
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6 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011819-20 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Male or female gender,
• Aged from 18 to 60 years,
• LQT3 syndrome genotype confirmed in medical file,
• QTc interval more or equal to 470 ms,
• Wearing an ICD,
• Accepting to participate to the study and able to understand and sign an approved Informed Consent Form,
• Able to understand the protocol and to come to the control visits,
• Likely to be compliant during the study, according to the judgement of the investigator,
• Registered with a social security or health insurance system.
For women of child bearing potential:
• Use of an efficient contraceptive for at least 2 months before the study and one month after the end of the study,
• Negative urine or blood pregnancy test.
Are the trial subjects under 18? no
Number of subjects for this age range:
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
* Criteria related to pathologies
• History of hypersensitivity or intolerance to one of the substances of content of the study drug (EPA ethyl ester, DHA ethyl ester, alpha-tocopherol, gelatin, soya),
• Severe hepatic impairment,
• High risk of haemorrhage,
• Any cardio-vascular, renal, gastro-intestinal, endocrine, haematological, neuro-psychiatric disease that will not be compatible with the participation to the study in the opinion of the investigator,
• Any acute or chronic disease that will not allow with the participation to the study in the opinion of the investigator.
* Criteria related to treatments
• Use of any medication that prolongs QT interval. The list of the Drugs to be Avoided by Patients with Congenital Long QT Syndrome is detailed on web site: www.QTdrugs.org (see appendix 17.2)
• Use of food complements enriched in n-3 PUFAs in the last 2 weeks.
* Criteria related to the way of life
Consumption of n-3 PUFAs rich foods (fat fishes, soya, colza and nut oils) > 3 times/week.
* Criteria related to the population
• Participation to another clinical study in the previous month or during the study or planning to participate to another clinical study within one month after the present study,
• Forfeited freedom by administrative or legal award, or under guardianship,
• Who cannot be contacted in case of emergency,
• Who planned travel outside the study area for a substantial portion of the study period.
For women of childbearing potential:
• Pregnancy,
• Breast-feeding.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Adult patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome, with implantable cardioverter defibrillator (ICD).
MedDRA version: 9.1
Level: LLT
Classification code 10057926
Term: Long QT syndrome congenital
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Intervention(s)
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Trade Name: OMACOR
Pharmaceutical Form: Capsule, soft
CAS Number: 25378272
Other descriptive name: EICOSAPENTAENOIC ACID
Concentration unit: % percent
Concentration type: equal
Concentration number: 46-
Other descriptive name: DOCOSAHEXAENOIC ACID
Concentration unit: % percent
Concentration type: equal
Concentration number: 38-
Other descriptive name: A-TOCOPHEROL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-per capsule
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Primary Outcome(s)
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Primary end point(s): The main criterion is defined as the modification of the QT interval corrected for heart rate (QTc) using the Fridericia equation after 6 weeks of treatment.
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Secondary Objective: To assess the effect of Omacor® on:
- the T wave morphology,
- the standard ECG parameters: RR interval, QRS complex, PR interval,
- the relationship between the QTc Fridericia interval and the erythrocyte cellular membrane and cheek cells concentration in PUFAs.
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Main Objective: To assess the effect of Omacor on the electrocardiographic QTc Fridericia interval in LQT3 patients (cardiac sodium channel gene SCN5A mutation leading to congenital long-QT syndrome).
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Secondary ID(s)
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V00067 CA 201 1A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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