Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Forced Titration Study to Assess the Efficacy and Safety of Omacor, Co-Administered With Open-Label Atorvastatin Therapy, in Hypertriglyceridemic Subjects”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: October 2007

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)

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Lovaza arm
  • Lovaza + atorvastatin
• Active Comparator: atorvastatin arm
  • atorvastatin + placebo

Primary Measures

• Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No

Secondary Measures

• Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period
  • Time Frame: Baseline and Week 16
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00435045

Study ID Number: OM9L

ClinicalTrials.gov Identifier: NCT00435045

Health Authority: United States: Food and Drug Administration