At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 65 enrolled
Drug / intervention
Lovazadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
In Brief
A Phase 4 clinical trial evaluating Lovaza for High Triglycerides and 4 related conditions. Completed, enrolled 65 participants across 1 site.
Detailed Summary
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh Triglycerides, Hypercholesterolemia, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartJul 2009
Primary CompletionMar 2013
TodayJul 2026
First PostedFeb 2, 2009
Enrollment StartJul 1, 2009
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 17.4 years ago
Interventions
Lovazadrug
4 grams per day