Trial | NCT00678743  Report issue

Title

An Open-Label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    13
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.
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 Started
Aug 31
2007
Primary Completion
Aug 31
2009
Anticipated
Study Completion
Sep 30
2009
Anticipated
Last Update
May 16
2008
Estimate

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, Lovaza, Zocor

Criteria 

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
No Results Posted