An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia

An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia

The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.

This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.

Inclusion Criteria:

• Men and women, ages 18-79 inclusive
• Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals
• Fasting, untreated triglyceride (TG) level in the high to very high range
• Provide written informed consent and authorization for protected health information

Exclusion Criteria:

• Pregnancy
• Use of lipid-altering drugs which cannot be stopped
• History of certain cardiovascular conditions or cardiac surgery within the prior 6 months
• Body mass index above 40 kg per square meter
• Allergy or sensitivity to omega-3 fatty acids or to statin drugs
• Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
• Certain muscle, liver, kidney, lung or gastrointestinal conditions
• Certain medications
• Active cancers treated within prior 2 years (except non-melanoma skin cancer)