Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

Hypertriglyceridemia Clinical Trial

Official title: A Double Blind Randomized Controlled Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides.

Status Terminated

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.

Clinical Trial 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. ;

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

• Hypertriglyceridemia

• NCT number: NCT00672633
• Study type: Interventional
• Source: Children's Hospital Boston
• Status: Terminated
• Phase: Phase 2
• Start date: April 2008
• Completion date: March 2012