An Open-Label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
This trial is active, not recruiting.
|Treatment||omacor + simvastatin|
|Sponsor||Provident Clinical Research|
|Start date||August 2007|
|End date||August 2009|
|Trial size||13 participants|
|Trial identifier||NCT00678743, PRV-06009X|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
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
Male or female participants from 18 years up to 79 years old.
- 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
- Study drug compliance less than 50% in PRV-06009
- Any ongoing serious adverse event from PRV-06009
|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|
|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.|
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