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

• ClinicalTrials.gov Identifier: NCT00246636
• Recruitment Status: Completed
• First Posted: October 30, 2005
• Last Update Posted: December 14, 2009
• Sponsor: GlaxoSmithKline
• Information provided by: GlaxoSmithKline

Tracking Information

• First Submitted Date: October 28, 2005
• First Posted Date: October 30, 2005
• Last Update Posted Date: December 14, 2009
• Study Start Date: October 2005
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2009)

• 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 ]
• 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 ]

• Original Primary Outcome Measures (submitted: October 28, 2005): Change in serum triglycerides

Current Secondary Outcome Measures (submitted: September 11, 2009)

• 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 ]
• 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 ]

• Original Secondary Outcome Measures (submitted: October 28, 2005): Changes in other lipid and biomarker levels
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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

Brief Summary

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.

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

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Hypertriglyceridemia

Intervention

• Drug: Antara (fenofibrate) + Lovaza
  Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
• Drug: Antara (fenofibrate)
  Antara (fenofibrate) + placebo

Study Arms

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

  • Drug: Antara (fenofibrate) + Lovaza
  • Drug: Antara (fenofibrate)
• Experimental: OM5/LOV111859 (double-blind study) - Antara + Lovaza
  Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
  Intervention: Drug: Antara (fenofibrate) + Lovaza

Publications *

• 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. doi: 10.3810/pgm.2009.09.2061.
• Roth EM, Bays HE, Forker AD, Maki KC, Carter R, Doyle RT, Stein EA. Prescription omega-3 fatty acid as an adjunct to fenofibrate therapy in hypertriglyceridemic subjects. J Cardiovasc Pharmacol. 2009 Sep;54(3):196-203. doi: 10.1097/FJC.0b013e3181b0cf71.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2008): 167
• Original Enrollment (submitted: October 28, 2005): 150
• Actual Study Completion Date: March 2007
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00246636
• Other Study ID Numbers: OM5 program (Reliant); OM5/LOV111859 (original study); OM5X/LOV111860 (1st extension)
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Study Director, GSK
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: December 2009