Phase 3 N=245 Randomized Triple-blind Treatment

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

Hypertriglyceridemia

Bottom Line

View on ClinicalTrials.gov: NCT00435045 ↗

Enrolled (actual)

245

Serious AEs

—

Results posted

May 2009

Primary outcome: Primary: Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period — -40.2; -33.7 percent change — p=0.0002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin (Drug); atorvastatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-40.2; -33.7	0.0002 sig
SECONDARY Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-31.5; -27.4	—
SECONDARY Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	12.4; 10.0	—
SECONDARY Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-29.3; -31.5	—
SECONDARY Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-45.4; -26.9	—
SECONDARY Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-54.3; -37.0	—
SECONDARY Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-0.3; 1.5	—
SECONDARY Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-29.4; -16.0	—
SECONDARY Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-38.3; -34.5	—
SECONDARY Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-51.9; -34.0	—
SECONDARY Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	85.5; 4.2	—
SECONDARY Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	402.2; -5.6	—
SECONDARY Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-34.6; -32.2	—
SECONDARY Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	1.5; 0.5	—
SECONDARY Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-20.7; -9.7	—
SECONDARY Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	1.0; 5.1	—
SECONDARY Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	0.0; 1.2	—
SECONDARY Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-32.4; -25.9	—
SECONDARY Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-17.5; -3.3	—
SECONDARY Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-60.4; -50.3	—
SECONDARY Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-50.0; -38.9	—
SECONDARY Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period	-5.1; -1.6	—
SECONDARY Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period	-46.9; -39.0	—
SECONDARY Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period	-50.4; -46.3	—

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 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00435045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.