EUCTR2009-011819-20-FR进行中（未招募）1 期
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.
Pierre Fabre Médicament0 个研究点目标入组 6 人开始时间: 2009年4月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •* 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.
研究者
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