Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00246701

Acronym

COMBOS

Enrollment

256

Registered

2005-10-31

Start date

2005-11-01

Completion date

2006-06-01

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

omega-3-acid ethyl esters, simvastatin, Lovaza, High triglycerides

Brief summary

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy. Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

Detailed description

Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.

Interventions

DRUGSimvastatin

Simvastatin

DRUGSimvastatin + Lovaza

Simvastatin + Lovaza (omega-3-acid ethyl esters)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol	8 weeks

Secondary

Measure	Time frame
OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026