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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00246636
• Collaborator: (none)
• Enrollment: 167
• Arms: 3
• Duration (Months): 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia	Drug: Antara (fenofibrate) + Lovaza; Drug: Antara (fenofibrate)	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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]

Outcome Measures

Primary Outcome Measures

1. 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 [8 weeks]

2. 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 [8 weeks]

Secondary Outcome Measures

1. 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 [8 weeks]

2. 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 [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00246636
• Other Study ID Numbers: OM5 program (Reliant); OM5/LOV111859 (original study); OM5X/LOV111860 (1st extension)
• First Posted: Oct 30, 2005
• Last Update Posted: Dec 14, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Very high triglycerides; omega-3-acid ethyl esters; fenofibrate; Lovaza
• Additional relevant MeSH terms: Hypertriglyceridemia; Fenofibrate

Study Results

No Results Posted as of Dec 14, 2009