Phase 3
Completed N=188
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Source: ClinicalTrials.gov NCT00903409 ↗Enrolled (actual)
188
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) — 0.9; -9.4; -3.3 Percent change — p=<0.001
Summary
In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) |
0.9; -9.4; -3.3 | <0.001 sig |
| SECONDARY Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in "Switchers" vs. Non-switchers |
-5.4; -10.3; -8.3; -6.6; -8.1; -7.3 | — |
| SECONDARY Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial |
-0.2; -6.4; -1.5; 1.6; -6.3; -3.8 | — |
Eligibility Criteria
For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8.
FYI - entry criteria for LOV111818/OM6 (double-blind study)
Inclusion Criteria
- Men and women ages 18-79 years, inclusive
- Current therapy with a statin drug
- Triglyceride levels between 200 and 499 mg/dL
- Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
- Provide written informed consent and authorization for protected health information disclosure
Exclusion Criteria
- Sensitivity to statin drugs or omega-3 fatty acids
- Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
- Unexplained muscle pain or weakness
- History of pancreatitis
- Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
- Poorly controlled diabetes, or receiving insulin therapy
- Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
- Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
- Use of warfarin (Coumadin)
Data sourced from ClinicalTrials.gov (NCT00903409). 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. Informational only — not medical advice.