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

Condition(s) targeted: Hypertriglyceridemia

Intervention: Antara (fenofibrate) + Lovaza (Drug); Antara (fenofibrate) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

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

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

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

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)

Starting date: October 2005
Last updated: December 10, 2009