At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 32 enrolled
Drug / intervention
P-OM3 +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 Double-blind, Randomized, Placebo-controlled, Two-period Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Ethyl Esters on Low-density Lipoprotein Cholesterol in Subjects With Primary Hypercholesterolemia
In Brief
A Phase 4 clinical trial evaluating P-OM3 and Placebo for Primary Hypercholesterolemia. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hypercholesterolemia
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartJan 2010
Primary CompletionJul 2010
Study CompletionOct 2010
TodayJul 2026
First PostedSep 4, 2008
Enrollment StartJan 1, 2010
Primary CompletionJul 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.8 years ago
Interventions
P-OM3drug
4 grams/day - 4 one gram capsules
Placebodrug
4 grams/day - 4 one gram capsules