Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

This study has been terminated.
(Very slow recruitment.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Voula Osganian, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00672633
First received: April 30, 2008
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

The investigators will conduct a randomized clinical trial to evaluate the efficacy of Lovaza (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years old whose baseline triglycerides range from 150 mg/dl to 1000 mg/dl. Seventy subjects will be recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6 months or the control condition, a corn oil placebo, 4 tablets a day for 6 months. Participants in both the treatment and control groups will receive the standard of care, which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet that emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of fishes rich in omega-3 fatty acids, consistent with the American Heart Association recommendations. The primary outcome will be change in fasting triglycerides from baseline to 3 months. The investigators hypothesize that patients who receive LOVAZA will have significantly greater reductions in plasma triglyceride levels when compared to patients on placebo at 3 months.


Condition Intervention Phase
Hypertriglyceridemia
Drug: Lovaza
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides.

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Fasting Triglycerides [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Fasting Triglycerides


Secondary Outcome Measures:
  • LDL Cholesterol [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Low Density Lipoprotein Cholesterol

  • HDL Cholesterol [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    High Density Lipoprotein Cholesterol


Enrollment: 25
Study Start Date: April 2008
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A , Experimental
Lovaza, 4 grams/day orally for 6 months
Drug: Lovaza
Lovaza , 4 grams/day orally for 6 months
Other Name: Lovaza
Placebo Comparator: Corn Oil Pill
Corn Oil Pill, 4 pills/day orally for 6 months
Drug: Placebo
Corn Oil Pill, 4 pills/day orally for 6 months
Other Name: Corn Oil Pill

Detailed Description:

The investigators propose to conduct a placebo controlled, double blind, parallel group randomized trial to evaluate the efficacy of Lovaza (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years old whose baseline triglycerides range from150 mg/dl to 1000 mg/dl. Seventy subjects will be recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6 months or the control condition, a corn oil placebo, 4 tablets a day for 6 months. Participants in both the treatment and control groups will receive the standard of care, which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet that emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of fishes rich in omega-3 fatty acids, consistent with the American Heart Association recommendations (Kris-Etherton, 2003). Subjects will be randomized to the treatment or control condition after a 4 week run-in period of dietary education and advice. The primary outcome will be change in fasting triglycerides from baseline to 3 months.

2.0 SPECIFIC AIMS

2.1 Primary Aim/Outcome

  • To determine the efficacy of LOVAZA in reducing plasma triglyceride levels among adolescents, ages 12-19 years with mild to moderate hypertriglyceridemia. We hypothesize that patients who receive LOVAZA will have significantly greater reductions in plasma triglyceride levels when compared to patients on placebo at 3 months.

2.2 Secondary Aims/Outcome

  • To determine whether the efficacy of LOVAZA varies with duration of treatment, 3 months versus 6 months.
  • To determine the effects of LOVAZA on plasma HDL and LDL cholesterol at 3 months and 6 months.
  • To determine the effects of LOVAZA on systolic and diastolic blood pressure at 3 months and 6 months.

2.3 Exploratory Aims

  • To describe the effects of LOVAZA on vascular reactivity/endothelial function as measured by pulse amplitude at 3 months and 6 months.
  • To describe the effects of LOVAZA on levels of biomarkers of inflammation as measured by C-Reactive Protein at 3 months and 6 months.
  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 10-19 years old
  • Fasting Triglyceride levels of 150-1000 mg/dl at the screening and baseline visit
  • Ability to swallow pills
  • Informed consent from a parent or legal guardian of minors or adult subject
  • Written assent from the adolescent to participate in the study
  • English or Spanish speaking

Exclusion Criteria:

  • Food Allergy to Fish or any components of the pills which includes alpha tocopherol, partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol or corn oil, and iron oxide or iron oxide containing food color additives.
  • Pregnancy or positive urine pregnancy test for those females who have begun menstruating
  • Breast feeding
  • Alcohol Use: Patient is unable to abstain from alcohol use during the study. This will be assessed by asking the following questions: "During the past 30 days, on how many days did you have at least one drink of alcohol?"; "During the past 30 days, on how many days did you have 5 or more drinks of alcohol in a row, that is, within a couple of hours?"; "This study requires that you abstain from alcohol use during the course of the study. Do you think you can do this?"
  • Known Bleeding Disorder or Coagulopathy or treatment with anticoagulant medications or low platelet counts, abnormal PT, or PTT.
  • Significant cognitive or psychosocial disorder or medical illness that would limit participation in the trial.
  • Type 1 or 2 Diabetes or fasting glucose that is >=126 mg/dl
  • Liver disease or an ALT greater than 2 times upper limit of normal
  • Treatment with medications that affect triglyceride levels, including oral hypoglycemic agents or insulin.
  • Be currently taking the same oral contraceptive pills for less than the past three months or intend to change or discontinue prescription oral contraceptive pills used in the next seven months
  • Be currently taking any over-the-counter supplements that affect triglycerides or lipid metabolism including over the counter fish oil supplements.
  • Treatment for or diagnosis of a thyroid disorder or an elevated TSH level at baseline
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672633

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
GlaxoSmithKline
Investigators
Principal Investigator: Stavroula K Osganian, MD, ScD Children's Hospital Boston
Principal Investigator: Sara DeFerranti, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Voula Osganian, Physician Scientist, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00672633     History of Changes
Other Study ID Numbers: 08010028
Study First Received: April 30, 2008
Results First Received: March 8, 2013
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Omega 3 Fatty Acids
Triglycerides
Lovaza
Trial

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 01, 2014