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

NCT ID: NCT00746811

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

P-OM3 then Placebo

P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment.

Group Type: OTHER

P-OM3

Intervention Type: DRUG

4 grams/day - 4 one gram capsules

Placebo

Intervention Type: DRUG

4 grams/day - 4 one gram capsules

Placebo then P-OM3

Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.

Group Type: OTHER

P-OM3

Intervention Type: DRUG

4 grams/day - 4 one gram capsules

Placebo

Intervention Type: DRUG

4 grams/day - 4 one gram capsules

Interventions

P-OM3

4 grams/day - 4 one gram capsules

Intervention Type: DRUG

Placebo

4 grams/day - 4 one gram capsules

Intervention Type: DRUG

Other Intervention Names

Lovaza

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Provident Clinical Research

OTHER

Sponsor Role: lead

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Kevin C. Maki, PhD

Study Director/Chief Science Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin C. Maki, PhD

Role: STUDY_DIRECTOR

Provident Clinical Research

Locations

Provident Clinical Research

Addison, Illinois, United States

Countries

United States

References

Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM, Marshall JW. Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. J Cardiovasc Pharmacol. 2011 Apr;57(4):489-94. doi: 10.1097/FJC.0b013e318210fca5.

Reference Type: RESULT

PMID: 21297494 (View on PubMed)

Other Identifiers

PRV-08007

Identifier Type: -

Identifier Source: org_study_id