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

This study has been completed.
Reliant Pharmaceuticals
Information provided by:
Provident Clinical Research Identifier:
First received: June 14, 2007
Last updated: April 28, 2008
Last verified: April 2008
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 Intervention Phase
Mixed Dyslipidemia
Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin
Drug: simvastatin plus placebo
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Provident Clinical Research:

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

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

Biospecimen Retention:   Samples Without DNA
serum and plasma

Enrollment: 40
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00487591

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

Maki KC; McKenney JM; Lubin BC; Reeves MS. Lipid effects of prescription omega-3-acid ethyl esters plus simvastatin in subjects with hypertriglyceridemia. FASEB J 2008;22:147.8
Maki KC; McKenney JM; Reeves MS; Lubin BC; Dicklin MR. Effects of prescription omega-3-acid ethyl esters plus simvastatin on lipids and lipoprotein particles in mixed dyslipidemia. J Clin Lipidol 2008 May/June; In press

Responsible Party: Kevin C. Maki, PhD, Chief Science Officer, Provident Clinical Research Identifier: NCT00487591     History of Changes
Other Study ID Numbers: PRV-06009
Study First Received: June 14, 2007
Last Updated: April 28, 2008

Keywords provided by Provident Clinical Research:
omega 3

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on April 28, 2017