Official Title: “An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia”

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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: August 2007

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• : Simva+Omacor
• : Simva + Placebo

Primary Measures

• Change in non-high-density lipoprotein cholesterol (non-HDL-C)
  • Time Frame: Baseline to end of treatment
    Safety Issue?: No

Secondary Measures

• Changes in other lipid and biomarker levels
  • Time Frame: Baseline through end of treatment
    Safety Issue?: 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Provident Clinical Research

Overall Clinical Trial Officials and Contacts

Kevin C Maki, PhD Study Director Provident Clinical Research  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00487591

Study ID Number: PRV-06009

ClinicalTrials.gov Identifier: NCT00487591

Health Authority: United States: Institutional Review Board