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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00672633
Other study ID # 08010028
Secondary ID
Status Terminated
Phase Phase 2
First received April 30, 2008
Last updated May 24, 2013
Start date April 2008
Est. completion date March 2012

Study information

Verified date May 2013
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date March 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 19 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Lovaza
Lovaza , 4 grams/day orally for 6 months
Placebo
Corn Oil Pill, 4 pills/day orally for 6 months

Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital Boston GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fasting Triglycerides Fasting Triglycerides 3 months No
Secondary LDL Cholesterol Low Density Lipoprotein Cholesterol 3 months No
Secondary HDL Cholesterol High Density Lipoprotein Cholesterol 3 months No
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