At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 245 enrolled
Drug / intervention
Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin +1 moredrug
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.
A Randomized, Double-Blind, Placebo-Controlled, Forced Titration Study to Assess the Efficacy and Safety of Omacor, Co-Administered With Open-Label Atorvastatin Therapy, in Hypertriglyceridemic Subjects
In Brief
A Phase 3 clinical trial evaluating Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin and atorvastatin for Hypertriglyceridemia. Completed, enrolled 245 participants.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in hypertriglyceridemic subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertriglyceridemia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedFeb 2007
Primary CompletionOct 2007
TodayJul 2026
First PostedFeb 14, 2007
Enrollment StartFeb 1, 2007
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 19.4 years ago
Interventions
Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatindrug
Lovaza + atorvastatin
atorvastatindrug
atorvastatin + placebo