Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00246636

Purpose

The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.

The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.

Condition	Intervention	Phase
Hypertriglyceridemia	Drug: Antara (fenofibrate) + Lovaza Drug: Antara (fenofibrate)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated With Antara, Followed by an 8-week Extension

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides

Drug Information available for: Procetofen Omacor

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5X [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	167
Study Start Date:	October 2005
Study Completion Date:	March 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
OM5/LOV111859 (double-blind study) - Antara: Active Comparator Antara (fenofibrate) + placebo	Drug: Antara (fenofibrate) Antara (fenofibrate) + placebo
OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza: Experimental Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]	Drug: Antara (fenofibrate) + Lovaza Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] Drug: Antara (fenofibrate) Antara (fenofibrate) + placebo
OM5/LOV111859 (double-blind study) - Antara + Lovaza: Experimental Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]	Drug: Antara (fenofibrate) + Lovaza Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]

Detailed Description:

Three studies comprise this OM5 Program

Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636.
Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293

Eligibility

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

Criteria

For OM5/LOV111858 -

Inclusion Criteria:

Men and women ages 18-79 years, inclusive
Triglyceride levels between 500 mg/dL and <1300 mg/dL
Body mass index between 25 and 43 kg/m2
Willingness to follow a low-saturated fat diet during the study period and maintain current physical activity level
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 fibrate drugs or omega-3 fatty acids
Lipoprotein lipase impairment or apo C-2 deficiency or Type III hyperlipidemia
History of pancreatitis
Recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer (except non-melanoma skin cancer)
Poorly controlled diabetes mellitus
Type 1 diabetes
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 isotretinoin (Accutane)
Use of warfarin (Coumadin)

For OM5X/LOV111859 -

Subjects were included in the study if they met the following criteria:

Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation
Successfully completed the previous OM5 double-blind study to Week 8
Provided written informed consent on or before the Week 8 clinic visit of the OM5 double-blind study (i.e., Visit 1X of the OM5X extension study)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246636

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 National Clinical Trials Identifier (NCT ID):

Bays HE, Maki KC, Doyle RT, Stein E. The effect of prescription omega-3 fatty acids on body weight after 8 to 16 weeks of treatment for very high triglyceride levels. Postgrad Med. 2009 Sep;121(5):145-50.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OM5 program (Reliant), OM5/LOV111859 (original study), OM5X/LOV111860 (1st extension)
Study First Received:	October 28, 2005
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00246636 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Very high triglycerides
omega-3-acid ethyl esters
fenofibrate
Lovaza

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Hypertriglyceridemia
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Procetofen
Pharmacologic Actions
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009