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

NCT00746811 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-31

Study results available
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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.

Conditions

  • Primary Hypercholesterolemia

Interventions

DRUG

P-OM3

4 grams/day - 4 one gram capsules

DRUG

Placebo

4 grams/day - 4 one gram capsules

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Provident Clinical Research

    lead OTHER

Principal Investigators

  • Kevin C. Maki, PhD · Provident Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-07-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00746811 on ClinicalTrials.gov