Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides
Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital