An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia

Study Overview
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Brief Summary
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The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.

Detailed Description
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This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.

Official Title
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An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia

Conditions
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Mixed Dyslipidemia

Intervention / Treatment
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* Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin
* Drug: simvastatin plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, ages 18-79 inclusive Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals Fasting, untreated triglyceride (TG) level in the high to very high range Provide written informed consent and authorization for protected health information Exclusion Criteria: Pregnancy Use of lipid-altering drugs which cannot be stopped History of certain cardiovascular conditions or cardiac surgery within the 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simva+Omacor<br> | Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin<br>* Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg)<br>* Other names: Lovaza;|
| Simva + Placebo<br> | Drug: simvastatin plus placebo<br>* simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in non-high-density lipoprotein cholesterol (non-HDL-C) |  | Baseline to end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipid and biomarker levels |  | Baseline through end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, dyslipidemia, omega 3