Conditions: Dyslipidemias
Keywords: cholesterol dyslipidemia omega 3
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief 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.

Detailed description:
The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits.

The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study:

* Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial.
* Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.

Arms:
arm 1: Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.

Interventions: intervention 1: Omacor + simvastatin
Intervention descriptions: intervention 1: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.

Protocol document: