Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in hypertriglyceridemic subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Men and women, ages 18-79 years, inclusive

• Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C) level above NCEP ATPIII goals

• Fasting, untreated triglyceride (TG) level in the high to very high range

• Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

• Pregnancy

• Use of lipid-altering drugs which cannot be stopped

• History of certain cardiovascular conditions or cardiac surgery within 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)