Healthy volunteers intended indication of the product: primary and secondary prevention of cardiovascular morbidity and mortality
Conditions
Interventions
Trade Name: OMACOR
Product Name: OMACOR
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ETHYL ICOSAPENTATE
CAS Number: 73310108
Current Sponsor code: CCB-KARD-09-01
Other descriptive name: Ico
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age 18-60 years - male and female - no known history of chronic diseases - effective contraception in women- of childbearing age 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
Exclusion criteria: - BMI >30 kg/m2 - intolerance to study medication (OMACOR) or its ingredients (soya bean oil, peanuts) - aterial blood pressure >150/90 mm Hg - consumption og marine fish > 1 meal/week or Omega-3-Index > 6 - regular intake of other diet supplements, which have an influence on metabolism of PUFA (e.g. vitamin E) - regular intake of other medication (except for contraceptives, thyroid hormones) - pregnancy and lactation period - inherited lipometabolic disorders - coagulation disorders and intake of anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in ratio of omega-3/omega-6 derived cytochrome-P450-dependent epoxyeicosanoids in erythrocytes by treatment with 1g and 2g of purified omega-3 PUFA (Omacor);Secondary Objective: - absolute and relative change in fatty acid profile in erythrocytes and urin - change in heart rate variability - change in inflammory markers;Primary end point(s): change in ratio of Omega-3/Omega-6 PUFA derived epoxyeicosanoids in erythocytes | — |
Countries
Germany
Outcome results
None listed