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NCT00672633 · ClinicalTrials.gov registry record · Phase 2
Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides
A Phase 2 study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00672633: Clinical Trial Phase 2 study, sponsored by Boston Children's Hospital.
NCT00672633 is a Phase 2 study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00672633, a Phase 2 study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
Fasting Triglycerides
Interventions
- DRUG Placebo
- DRUG Lovaza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
Why NCT00672633 stopped before completion
NCT00672633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00672633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00672633 about?
NCT00672633 is a clinical study titled "Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides". 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 r...
What is the current status of trial NCT00672633?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2008-04. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00672633?
The interventions under investigation include: Placebo (DRUG), Lovaza (DRUG).
Who is sponsoring clinical trial NCT00672633?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00672633's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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