An Open-Label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
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|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
Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.Other Names:
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678743
|Study Director:||Kevin C. Maki, PhD||Provident Clinical Research|