Mixed Dyslipidemia Clinical Trial
Official title:
An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate Simvastatin 20 mg Plus Omacor 4g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
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.
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
vists.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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