An Open-Label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
|ClinicalTrials.gov Identifier: NCT00678743|
Recruitment Status : Unknown
Verified May 2008 by Provident Clinical Research.
Recruitment status was: Active, not recruiting
First Posted : May 16, 2008
Last Update Posted : May 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Mixed Dyslipidemia||Drug: Omacor + simvastatin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2007|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||September 2009|
Drug: Omacor + simvastatin
- Omega-3-acid ethyl esters
- 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 ]
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678743
|Study Director:||Kevin C. Maki, PhD||Provident Clinical Research|