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

Provident Clinical Research

Status and phase: Completed; Phase 4

Conditions: Primary Hypercholesterolemia

Treatments: Drug: P-OM3; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00746811

PRV-08007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

P-OM3 then Placebo

Other group

Description:

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

Treatment:

Drug: Placebo

Drug: P-OM3

Placebo then P-OM3

Other group

Description:

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

Treatment:

Drug: Placebo

Drug: P-OM3