Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia

NCT ID: NCT00435045

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-10-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in hypertriglyceridemic subjects.

Detailed Description

Randomized, double-blind, placebo-controlled, parallel-group study design with eleven clinic visits (one screening visit, three lead-in/baseline visits, and seven treatment visits) After a 4-week diet only lead-in period, subjects with a triglyceride (TG) level in the high to very high range and with non-HDL-C level above NCEP ATPIII goals will be randomized to receive either open-label atorvastatin 10 mg per day plus double-blinded Lovaza 4g (4 x 1g capsules) per day OR open-label atorvastatin 10 mg per day plus a double-blinded matching placebo (4 corn oil capsules per day) for 8 weeks After the initial 8-week treatment period, the dose of open-label atorvastatin will be titrated to 20 mg per day (with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day) for an additional 4 weeks At Week 12, a second open-label titration to 40 mg of open-label atorvastatin per day will be maintained for an additional 4 weeks (again with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day)

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

atorvastatin arm

atorvastatin + placebo

Group Type: ACTIVE_COMPARATOR

atorvastatin

Intervention Type: DRUG

atorvastatin + placebo

Lovaza arm

Lovaza + atorvastatin

Group Type: EXPERIMENTAL

Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin

Intervention Type: DRUG

Lovaza + atorvastatin

Interventions

Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin

Lovaza + atorvastatin

Intervention Type: DRUG

atorvastatin

atorvastatin + placebo

Intervention Type: DRUG

Other Intervention Names

Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin

Eligibility Criteria

Inclusion Criteria

• Men and women, ages 18-79 years, inclusive
• Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C) level above NCEP ATPIII goals
• Fasting, untreated triglyceride (TG) level in the high to very high range
• Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria

• Pregnancy
• Use of lipid-altering drugs which cannot be stopped
• History of certain cardiovascular conditions or cardiac surgery within prior 6 months
• Body mass index above 40 kg per square meter
• Allergy or sensitivity to omega-3 fatty acids or to statin drugs
• Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
• Certain muscle, liver, kidney, lung, or gastrointestinal conditions
• Certain medications
• Active cancers treated within prior 2 years (except non-melanoma skin cancer)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Bays HE, McKenney J, Maki KC, Doyle RT, Carter RN, Stein E. Effects of prescription omega-3-acid ethyl esters on non--high-density lipoprotein cholesterol when coadministered with escalating doses of atorvastatin. Mayo Clin Proc. 2010 Feb;85(2):122-8. doi: 10.4065/mcp.2009.0397.

Reference Type: BACKGROUND

PMID: 20118387 (View on PubMed)

Maki KC, Bays HE, Dicklin MR, Johnson SL, Shabbout M. Effects of prescription omega-3-acid ethyl esters, coadministered with atorvastatin, on circulating levels of lipoprotein particles, apolipoprotein CIII, and lipoprotein-associated phospholipase A2 mass in men and women with mixed dyslipidemia. J Clin Lipidol. 2011 Nov-Dec;5(6):483-92. doi: 10.1016/j.jacl.2011.09.001. Epub 2011 Sep 13.

Reference Type: DERIVED

PMID: 22108152 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

OM9L

Identifier Type: -

Identifier Source: org_study_id