Trial to Assess the Effects of P-OM3 on LDL-C in Subjects With Primary Hypercholesterolemia

Study Overview
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Brief Summary
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The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.

Detailed Description
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This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.

Official Title
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A Double-blind, Randomized, Placebo-controlled, Two-period Crossover Trial to Assess the Effects of 4 g/d P-OM3 on LDL-C and Other Aspects of the Fasting Lipid Profile in Subjects With Primary Hypercholesterolemia

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: P-OM3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, ages 18-79 inclusive Fasting, untreated low-density lipoprotein cholesterol (LDL-C)level in the borderline high to very high range Fasting, untreated triglyceride (TG)level in the normal range Provide written informed consent and authorization for protected health information Exclusion Criteria: CHD or CHD risk equivalent Pregnancy Use of lipid altering medications which cannot be stopped Body mass index over 45 kg per square meter Allergy or sensitivity to omega-3 fatty acids Certain muscle, liver, kidney, lung or gastrointestinal conditions Poorly controlled hypertension 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>P-OM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment. | Drug: P-OM3<br>* 4 grams/day - 4 one gram capsules<br>* Other names: Lovaza;Drug: Placebo<br>* 4 grams/day - 4 one gram capsules<br>|
| Other: 2<br>Placebo for the first six weeks of treatment. P-OM3 for the second six weeks of treatment. | Drug: P-OM3<br>* 4 grams/day - 4 one gram capsules<br>* Other names: Lovaza;Drug: Placebo<br>* 4 grams/day - 4 one gram capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome variable will be the percent change from baseline in LDL-C during each treatment. |  | 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, hypercholesterolemia, omega 3