Overview

This trial is active, not recruiting.

Condition mixed dyslipidemia
Treatment omacor + simvastatin
Phase phase 4
Sponsor Provident Clinical Research
Collaborator Reliant Pharmaceuticals
Start date August 2007
End date August 2009
Trial size 13 participants
Trial identifier NCT00678743, PRV-06009X

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Provident Clinical Research.