Last updated: 11/07/2018 18:03:15

Evaluation of Efficacy and Safety of Omacor, Co-Administered with Atorvastatin, in Subjects with HypertriglyceridemiaNot applicable

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GSK study ID
OM9L
See study documents
Clinicaltrials.gov ID
NCT00435045
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Controlled, Forced Titration Study to Assess the Efficacy and Safety of Omacor, Co-Administered with Open-Label Atorvastatin Therapy, in Hypertriglyceridemic Subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Secondary outcomes:

Percent Change in Total Cholesterol (TC) from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in High Density Lipoprotein (HDL)Cholesterol from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Low Density Lipoprotein (LDL) Cholesterol (beta-quantification) from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Triglycerides from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Apolipoprotein-A-1 from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Apolipoprotein C-III from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Docosahexaenoic Acid (DHA) from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Eicosapentaenoic Acid (EPA) from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Low Density Lipoprotein Particle Concentration Total from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Low Density Lipoprotein Particle Size from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Lipoprotein-Phosphoslipase A2 from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in High Density Lipoprotein (HDL) Particle Size from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Very Low Density Lipoproteins Size from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Intermediate Density Lipoprotein Particle Concentration from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Remnant-like particle cholesterol from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Total Adiponectin from Baseline to Week 8 during 10 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 8

Percent Change in Non-High Density Lipoprotein Cholesterol from Baseline to Week 12 during 20 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 12

Percent Change in Non-High Density Lipoprotein Cholesterol from Baseline to Week 16 during 40 mg Atorvastatin Treatment Period

Timeframe: Baseline and Week 16

Interventions:
  • Drug: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin
  • Drug: atorvastatin
    • Enrollment:
    245
    Primary completion date:
    2007-22-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bays H, McKenney J, Maki KC, et al. Prescription omega-3-acid ethyl esters: effects on non-high-density lipoprotein cholesterol in combined hyperlipidemic patients when combined with escalating doses of atorvastatin. Mayo Clin Proc. 2010; 85:122-128
    Medical condition
    Hypertriglyceridemia
    Product
    GI104000, GSK2295313, omega-3-acid ethyl esters
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to October 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • Men and women, ages 18-79 years, inclusive
    • Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C) level above NCEP ATPIII goals
    • Pregnancy
    • Use of lipid-altering drugs which cannot be stopped
    Inclusion and exclusion 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)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-22-10
    Actual study completion date
    2007-22-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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