Phase 4
N=16
An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
Dyslipidemias
Bottom Line
View on ClinicalTrials.gov: NCT00678743 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omacor + simvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Provident Clinical Research
- Primary completion
- Aug 2009
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 | — |
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.
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). 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.