An Open-Label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
Recruitment status was Active, not recruiting
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 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 ] [ Designated as 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 52 of PRV-06009X open-label treatment [ Time Frame: 52 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||September 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Drug: Omacor + simvastatin
- Omega-3-acid ethyl esters
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678743
|Study Director:||Kevin C. Maki, PhD||Provident Clinical Research|