An Open-Label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Mixed Dyslipidemia

• NCT number: NCT00678743
• Study type: Interventional
• Source: Provident Clinical Research
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 2007
• Completion date: September 2009