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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Omacor + simvastatin
  • Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.

Primary Measures

• 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
  • Time Frame: Week 6
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: 52 weeks
    Safety Issue?: No
• 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
  • Time Frame: 104 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Provident Clinical Research

Overall Clinical Trial Officials and Contacts

Kevin C. Maki, PhD Study Director Provident Clinical Research  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00678743

Study ID Number: PRV-06009X

ClinicalTrials.gov Identifier: NCT00678743

Health Authority: United States: Institutional Review Board