An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia - Full Text View

Sponsor:	Provident Clinical Research
Collaborator:	Reliant Pharmaceuticals
Information provided by:	Provident Clinical Research
ClinicalTrials.gov Identifier:	NCT00487591

Purpose

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:

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Omega-3-acid Ethyl Esters Lovaza

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in other lipid and biomarker levels [ Time Frame: Baseline through end of treatment ] [ Designated as safety issue: No ]

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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487591

Sponsors and Collaborators

Provident Clinical Research

Reliant Pharmaceuticals

Investigators

Study Director:

Kevin C Maki, PhD

Provident Clinical Research

More Information

Publications:

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 adding prescription omega-3 acid ethyl esters to simvastatin (20 mg/day) on lipids and lipoprotein particles in men and women with mixed dyslipidemia. Am J Cardiol. 2008 Aug 15;102(4):429-33. Epub 2008 May 22.

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

Keywords provided by Provident Clinical Research:

cholesterol
dyslipidemia
omega 3

Additional relevant MeSH terms:

Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 24, 2012