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

Phase 4

• Conditions: Mixed Dyslipidemia

• Registration Number: NCT00678743
• Lead Sponsor: Provident Clinical Research

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 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 Timeline

• Study Start: 2007-08
• Status Verified: 2008-05
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Last Update Submitted: 2008-05-14
• Study First Posted: 2008-05-16
• Last Update Posted: 2008-05-16
• Primary Completion: 2009-08
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint will be the percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to Week 6 of PRV-06009X	Week 6

Secondary Outcome Measures

Name	Time	Method
The percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to week 52 of PRV-06009X open-label treatment	52 weeks
The percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 double-blind study to week 104 of PRV-06009X open-label treatment	104 weeks