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Clinical trialNCT00672633TerminatedPhase 2Interventional

Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

SponsorBoston Children's HospitalEnrollment25Hypertriglyceridemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Children'S Hospital Boston

    Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

LovazaPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2008
Primary completion
31 Dec 2011
Completion
31 Mar 2012
Last update posted
29 May 2013
Registered enrollment
25
Registry id
NCT00672633

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.