Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertriglyceridemia
Intervention: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin (Drug); atorvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period
Secondary outcome: Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment PeriodPercent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period
Detailed 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)
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
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)
Locations and Contacts
Additional Information
Related publications: Bays HE, McKenney J, Maki KC, Doyle RT, Carter RN, Stein E. Effects of prescription omega-3-acid ethyl esters on non--high-density lipoprotein cholesterol when coadministered with escalating doses of atorvastatin. Mayo Clin Proc. 2010 Feb;85(2):122-8. doi: 10.4065/mcp.2009.0397.
Starting date: February 2007
Last updated: September 3, 2010
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