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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246636
• Other study ID #: OM5 program (Reliant)
• Secondary ID: OM5/LOV111859 (o
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2005
• Last updated: December 10, 2009
• Start date: October 2005
• Est. completion date: March 2007

Study information

• Verified date: December 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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