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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
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by:
Provident Clinical Research

Brief 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.

Condition or disease Intervention/treatment Phase
Mixed Dyslipidemia Drug: Omacor + simvastatin Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Provident Clinical Research
Reliant Pharmaceuticals
Investigators
Study Director: Kevin C. Maki, PhD Provident Clinical Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin C. Maki, PhD, Chief Science Officer, Provident Clinical Research
ClinicalTrials.gov Identifier: NCT00678743     History of Changes
Other Study ID Numbers: PRV-06009X
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008

Keywords provided by Provident Clinical Research:
cholesterol
dyslipidemia
omega 3

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors