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

Condition(s) targeted: Mixed Dyslipidemia

Intervention: Omacor + simvastatin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Provident Clinical Research

Official(s) and/or principal investigator(s):
Kevin C. Maki, PhD, Study Director, Affiliation: Provident Clinical Research

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.

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

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

Primary outcome: 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

Secondary outcome:

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

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

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.

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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

Starting date: August 2007
Ending date: September 2009
Last updated: May 14, 2008