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

Last updated: December 2, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT00435045
OM9L
  • Ages 18-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

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

  • Provide written informed consent and authorization for protected health informationdisclosure

Exclusion

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)

Study Design

Total Participants: 245
Study Start date:
February 01, 2007
Estimated Completion Date:
October 31, 2007

Study Description

Randomized, double-blind, placebo-controlled, parallel-group study design with eleven clinic visits (one screening visit, three lead-in/baseline visits, and seven treatment visits) After a 4-week diet only lead-in period, subjects with a triglyceride (TG) level in the high to very high range and with non-HDL-C level above NCEP ATPIII goals will be randomized to receive either open-label atorvastatin 10 mg per day plus double-blinded Lovaza 4g (4 x 1g capsules) per day OR open-label atorvastatin 10 mg per day plus a double-blinded matching placebo (4 corn oil capsules per day) for 8 weeks After the initial 8-week treatment period, the dose of open-label atorvastatin will be titrated to 20 mg per day (with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day) for an additional 4 weeks At Week 12, a second open-label titration to 40 mg of open-label atorvastatin per day will be maintained for an additional 4 weeks (again with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day)