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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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00246636
First received: October 28, 2005
Last updated: December 10, 2009
Last verified: December 2009
History of Changes
  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 4

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, 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
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
Active Comparator: OM5/LOV111859 (double-blind study) - Antara
Antara (fenofibrate) + placebo
 Drug: Antara (fenofibrate)
Antara (fenofibrate) + placebo
Experimental: OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
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
Experimental: OM5/LOV111859 (double-blind study) - Antara + Lovaza
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:

  1. Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation
  2. Successfully completed the previous OM5 double-blind study to Week 8
  3. 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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00246636     History of Changes
Other Study ID Numbers: OM5 program (Reliant), OM5/LOV111859 (original study), OM5X/LOV111860 (1st extension)
Study First Received: October 28, 2005
Last Updated: December 10, 2009
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:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013