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OpenTrials
Completed

NCT Number: NCT00678743

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

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.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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 visits.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omacor + simvastatin

Drug

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

Primary outcomes

  1. Median % Change in Non-HDL-C From Baseline to Week 6

    Time frame: Week 6

    The primary efficacy endpoint will be the median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to Week 6 of PRV-06009X.

    Briefly, non-HDL-C was measured at Weeks -2, -1, and 0 from blood samples, and the concentrations of non-HDL-C in the blood at these timepoints were averaged to obtain baseline non-HDL-C concentration. Similarly, non-HDLC was measured at Week 6 from blood samples. Statistical analysis was performed comparing the change in non-HDL-C concentration from baseline to Week 6 and presented herein.

Secondary outcomes

  1. Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin

    Time frame: 52 weeks

    The median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to week 52 of PRV-06009X open-label treatment

  2. Median % Change in Non-HDL-C From Baseline to Week 104

    Time frame: 104 weeks

    The median percent change in non-HDL-C from baseline (average of weeks -2, -1, and 0) of the PRV-06009 (NCT00487591) double-blind study to week 104 of PRV-06009X open-label treatment

Sponsors and collaborators

Lead sponsor

Provident Clinical Research

Other

Collaborators

  • Reliant Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 16, 2008
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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