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Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects

NCT ID: NCT00903409

Last Updated: 2017-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-15

Study Completion Date

2008-06-27

Brief Summary

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In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) \[formerly known as Omacor\] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.

Detailed Description

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Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.

Conditions

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Hypertriglyceridemia

Keywords

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High triglycerides Lovaza simvastatin omega-3-acid ethyl esters

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Simvastatin + Lovaza® ("Non-switchers")

Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + Lovaza® in the double-blind trial, hence in this open-label extension, they are termed "Non-switchers"

Group Type EXPERIMENTAL

Simvastatin + Lovaza® (omega-3-acid ethyl esters)

Intervention Type DRUG

Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]

Simvastatin + Lovaza® ("Switchers")

Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + placebo in the double-blind trial, hence in this open-label extension, they are termed "Switchers"

Group Type EXPERIMENTAL

Simvastatin + Lovaza® (omega-3-acid ethyl esters)

Intervention Type DRUG

Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]

Interventions

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Simvastatin + Lovaza® (omega-3-acid ethyl esters)

Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]

Intervention Type DRUG

Eligibility Criteria

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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

FYI - entry criteria for LOV111818/OM6 (double-blind study)


* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mobile, Alabama, United States

Site Status

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Encinitas, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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Sacramento, California, United States

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Thousand Oaks, California, United States

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Hollywood, Florida, United States

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Pinellas Park, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Dunwoody, Georgia, United States

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Suwanee, Georgia, United States

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Chicago, Illinois, United States

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Bloomington, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Edina, Minnesota, United States

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Wentzville, Minnesota, United States

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Kansas City, Missouri, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Bristol, Tennessee, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Lakewood, Washington, United States

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GSK Investigational Site

Seattle, Washington, United States

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Countries

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United States

References

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Bays HE, Maki KC, McKenney J, Snipes R, Meadowcroft A, Schroyer R, Doyle RT, Stein E. Long-term up to 24-month efficacy and safety of concomitant prescription omega-3-acid ethyl esters and simvastatin in hypertriglyceridemic patients. Curr Med Res Opin. 2010 Apr;26(4):907-15. doi: 10.1185/03007991003645318.

Reference Type BACKGROUND
PMID: 20156032 (View on PubMed)

Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. Am J Cardiol. 2010 May 15;105(10):1409-12. doi: 10.1016/j.amjcard.2009.12.063. Epub 2010 Mar 30.

Reference Type BACKGROUND
PMID: 20451686 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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LOV111858

Identifier Type: OTHER

Identifier Source: secondary_id

111818

Identifier Type: -

Identifier Source: org_study_id