Phase 4
Completed N=16
An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
Dyslipidemias
Source: ClinicalTrials.gov NCT00678743 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Median % Change in Non-HDL-C From Baseline to Week 6 — -51.0; -40.8; -34.9 Median percent change from baseline — p=0.0008
◆ 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 primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.
Linked Publications
-
Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median % Change in Non-HDL-C From Baseline to Week 6 |
-51.0; -40.8; -34.9 | 0.0008 sig |
| SECONDARY Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin |
-50.33; -40.39 | — |
| SECONDARY Median % Change in Non-HDL-C From Baseline to Week 104 |
-53.46; -51.25 | — |
Eligibility Criteria
Inclusion Criteria
- Must have met all relevant inclusion/exclusion criteria prior to and throughout the previous double-blind study (PRV-06009)
- Must have completed the previous double-blind study to week 12.
- Provide written informed consent and authorization for protected health information
Exclusion Criteria
- Study drug compliance less than 50% in PRV-06009
- Any ongoing serious adverse event from PRV-06009
Data sourced from ClinicalTrials.gov (NCT00678743) 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.