Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia

Provident Clinical Research32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Primary Hypercholesterolemia

Interventions

P-OM3DRUG

4 grams/day - 4 one gram capsules

PlaceboDRUG

4 grams/day - 4 one gram capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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)

Locations (1)

Provident Clinical Research

Addison, Illinois, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in LDL-C During Each Treatment

The primary outcome variable will be the percent change from baseline in LDL-C during each treatment. Baseline will be considered the average of values obtained at weeks -1 and 0. On-treatment values will be the average of values collected at weeks 5 and 6 for phase 1, and the average of values collected at weeks 11 and 12 for phase 2.

Time frame: Baseline (average of weeks -1 and 0) and after 5 or 6 weeks of intervention (average of weeks 5 and 6 for the first treatment phase; average of weeks 11 and 12 for the second treatment phase).

Secondary Outcomes

Percent Changes in Other Lipid and Biomarker Levels

Percent changes from baseline in the levels of TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio and Apo AI and B. Baseline and on-treatment values for TC, HDL-C, non-HDL-C, VLDL-C, TG, TC/ HDL-C ratio will be calculated as described for LDL-C. Baseline values for Apo AI and B will include the average of values obtained at weeks -1 and 0. On-treatment values for Apo AI and B will be the average of values collected at weeks 6 and 12.

Data from ClinicalTrials.gov

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