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An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487591
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : May 7, 2008
Reliant Pharmaceuticals
Information provided by:
Provident Clinical Research

Brief Summary:
The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.

Condition or disease Intervention/treatment
Mixed Dyslipidemia Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin Drug: simvastatin plus placebo

Detailed Description:
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
Study Start Date : November 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Simva+Omacor Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin
Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg)
Other Name: Lovaza

Simva + Placebo Drug: simvastatin plus placebo
simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo

Primary Outcome Measures :
  1. Change in non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Baseline to end of treatment ]

Secondary Outcome Measures :
  1. Changes in other lipid and biomarker levels [ Time Frame: Baseline through end of treatment ]

Biospecimen Retention:   Samples Without DNA
serum and plasma

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

Inclusion Criteria:

  • Men and women, ages 18-79 inclusive
  • Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals
  • Fasting, untreated triglyceride (TG) level in the high to very high range
  • Provide written informed consent and authorization for protected health information

Exclusion Criteria:

  • Pregnancy
  • Use of lipid-altering drugs which cannot be stopped
  • History of certain cardiovascular conditions or cardiac surgery within the prior 6 months
  • Body mass index above 40 kg per square meter
  • Allergy or sensitivity to omega-3 fatty acids or to statin drugs
  • Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
  • Certain muscle, liver, kidney, lung or gastrointestinal conditions
  • Certain medications
  • Active cancers treated within prior 2 years (except non-melanoma skin cancer)

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 identifier (NCT number): NCT00487591

Sponsors and Collaborators
Provident Clinical Research
Reliant Pharmaceuticals
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Study Director: Kevin C Maki, PhD Provident Clinical Research
Publications of Results:
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Responsible Party: Kevin C. Maki, PhD, Chief Science Officer, Provident Clinical Research Identifier: NCT00487591    
Other Study ID Numbers: PRV-06009
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: April 2008
Keywords provided by Provident Clinical Research:
omega 3
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors