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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hypertriglyceridemia

Treatments

Drug: atorvastatin

Drug: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00435045

OM9L

Details and patient eligibility

About

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.

Full 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)

Enrollment

245 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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)