Phase 4
Completed N=32
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
Primary Hypercholesterolemia
Source: ClinicalTrials.gov NCT00746811 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Percent Change From Baseline in LDL-C During Each Treatment — 3.4; -0.7 Percent change from baseline
◆ Published Evidence
Established
31citations · ~2 / year
Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia.
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.
Linked Publications
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Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LDL-C During Each Treatment |
3.4; -0.7 | — |
| SECONDARY Percent Changes in Other Lipid and Biomarker Levels |
0.5; -0.7; -16.7; 2.0; 1.5; -1.7 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00746811) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.