NCT00746811

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

A Double-blind, Randomized, Placebo-controlled, Two-period Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Ethyl Esters on Low-density Lipoprotein Cholesterol in Subjects With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Provident Clinical Research · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Primary Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	P-OM3	4 grams/day - 4 one gram capsules
DRUG	Placebo	4 grams/day - 4 one gram capsules

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-07-01
• Completion: 2010-10-01
• First posted: 2008-09-04
• Last updated: 2024-05-31
• Results posted: 2024-05-08

Locations

1 site across 1 country: United States