Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia

A Double-blind, Randomized, Placebo-controlled, Two-period Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Ethyl Esters on Low-density Lipoprotein Cholesterol in Subjects With Primary Hypercholesterolemia

The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.

This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.

Inclusion Criteria:

• Men and women, ages 18-79 inclusive
• Fasting, untreated low-density lipoprotein cholesterol (LDL-C)level in the borderline high to very high range
• Fasting, untreated triglyceride (TG)level in the normal range
• Provide written informed consent and authorization for protected health information

Exclusion Criteria:

• CHD or CHD risk equivalent
• Pregnancy
• Use of lipid altering medications which cannot be stopped
• Body mass index over 45 kg per square meter
• Allergy or sensitivity to omega-3 fatty acids
• Certain muscle, liver, kidney, lung or gastrointestinal conditions
• Poorly controlled hypertension
• Certain medications
• Active cancers treated within prior 2 years (except non-melanoma skin cancer)