Trial to Assess the Effects of P-OM3 on LDL-C in Subjects With Primary Hypercholesterolemia

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Provident Clinical Research
• Collaborator: GlaxoSmithKline

Criteria

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)