Addison, Illinois 60101


Purpose:

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.


Study summary:

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.


Criteria:

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)


NCT ID:

NCT00746811


Primary Contact:

Study Director
Kevin C. Maki, PhD
Provident Clinical Research


Backup Contact:

N/A


Location Contact:

Addison, Illinois 60101
United States

John Marshall, RN, BSN
Phone: 630-617-2000
Email: research@providentcrc.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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