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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Provident Clinical Research
• Collaborator: Reliant Pharmaceuticals
• Treatments: Simvastatin

Criteria

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)