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

September 8, 2017 updated by: GlaxoSmithKline

OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (Previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • California
      • Encinitas, California, United States, 92024
        • GSK Investigational Site
      • Fresno, California, United States, 93710
        • GSK Investigational Site
      • Greenbrae, California, United States, 94904
        • GSK Investigational Site
      • Sacramento, California, United States, 95831
        • GSK Investigational Site
      • Thousand Oaks, California, United States, 91360
        • GSK Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33023
        • GSK Investigational Site
      • Pinellas Park, Florida, United States, 33781
        • GSK Investigational Site
      • Tampa, Florida, United States, 33606
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • GSK Investigational Site
      • Dunwoody, Georgia, United States, 30328
        • GSK Investigational Site
      • Suwanee, Georgia, United States, 30024
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • GSK Investigational Site
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • GSK Investigational Site
      • Evansville, Indiana, United States, 47714
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • GSK Investigational Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • GSK Investigational Site
      • Wentzville, Minnesota, United States, 62285
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10032
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
      • Hickory, North Carolina, United States, 28601
        • GSK Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28677
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28412
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27106
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45212
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • GSK Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
    • Texas
      • Plano, Texas, United States, 75093
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23249
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
    • Washington
      • Lakewood, Washington, United States, 98499
        • GSK Investigational Site
      • Seattle, Washington, United States, 98104
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8.

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

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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"
Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]
Experimental: 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"
Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)
Time Frame: Month 4 (LOV111818)
Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)
Month 4 (LOV111818)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in "Switchers" vs. Non-switchers
Time Frame: Months 4, 12, and 24 (LOV111818) of the open-label extension trial
Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial
Months 4, 12, and 24 (LOV111818) of the open-label extension trial
Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial
Time Frame: LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial
Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial
LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 111818
  • LOV111858 (Other Identifier: GSK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Dataset Specification
    Information identifier: 111818
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 111818
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 111818
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 111818
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 111818
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 111818
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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