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

An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00487591

Enrollment

Registered

2007-06-18

Start date

2006-11-30

Completion date

2007-08-31

Last updated

2008-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed Dyslipidemia

Keywords

cholesterol, dyslipidemia, omega 3

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.

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.

Interventions

DRUGOmacor (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)

DRUGsimvastatin plus placebo

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change in non-high-density lipoprotein cholesterol (non-HDL-C)	Baseline to end of treatment

Secondary

Measure	Time frame
Changes in other lipid and biomarker levels	Baseline through end of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026