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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Provident Clinical Research.
Recruitment status was  Active, not recruiting
Reliant Pharmaceuticals
Information provided by:
Provident Clinical Research Identifier:
First received: May 14, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
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 Intervention Phase
Mixed Dyslipidemia
Drug: Omacor + simvastatin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Provident Clinical Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: August 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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
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.

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00678743

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kevin C. Maki, PhD, Chief Science Officer, Provident Clinical Research Identifier: NCT00678743     History of Changes
Other Study ID Numbers: PRV-06009X 
Study First Received: May 14, 2008
Last Updated: May 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Provident Clinical Research:
omega 3

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2016