Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00246701

Purpose

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.

Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

Condition	Intervention	Phase
Hypertriglyceridemia	Drug: Simvastatin + Lovaza Drug: Simvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Triglycerides

Drug Information available for: Simvastatin Omacor

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	256
Study Start Date:	November 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Simvastatin Simvastatin + placebo	Drug: Simvastatin Simvastatin
Experimental: Simvastatin + Lovaza Simvastatin + Lovaza (omega-3-acid ethyl esters)	Drug: Simvastatin + Lovaza Simvastatin + Lovaza (omega-3-acid ethyl esters)

Detailed Description:

Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.

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 years, inclusive
Current therapy with a statin drug
Triglyceride levels between 200 and 499 mg/dL
Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

Sensitivity to statin drugs or omega-3 fatty acids
Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
Unexplained muscle pain or weakness
History of pancreatitis
Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
Poorly controlled diabetes, or receiving insulin therapy
Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
Use of warfarin (Coumadin)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246701

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. Am J Cardiol. 2010 May 15;105(10):1409-12. Epub 2010 Mar 30.

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00246701 History of Changes
Other Study ID Numbers:	OM6 program (Reliant), LOV111858 (OM6)
Study First Received:	October 28, 2005
Last Updated:	December 10, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

High triglycerides
omega-3-acid ethyl esters
simvastatin
Lovaza

Additional relevant MeSH terms:

Hypertriglyceridemia
Hyperlipidemias
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 February 09, 2012