Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects

Hypertriglyceridemia Clinical Trial

— COMBOS  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246701
• Other study ID #: OM6 program (Reliant)
• Secondary ID: LOV111818
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2005
• Last updated: March 24, 2017
• Start date: November 1, 2005
• Est. completion date: June 1, 2006

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.

Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

Description:

Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: June 1, 2006
• Est. primary completion date: June 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Men and women ages 18-79 years, inclusive

• Current therapy with a statin drug

• Triglyceride levels between 200 and 499 mg/dL

• 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 statin drugs or omega-3 fatty acids

• Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia

• Unexplained muscle pain or weakness

• History of pancreatitis

• Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)

• Poorly controlled diabetes, or receiving insulin therapy

• 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 warfarin (Coumadin)

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Simvastatin
Simvastatin
• Simvastatin + Lovaza
Simvastatin + Lovaza (omega-3-acid ethyl esters)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol		8 weeks
Secondary	OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels		8 weeks