CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 103 enrolled
Drug / intervention
OMACOR +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.

Search/NCT00760513
NCT00760513Phase 4Completed

The Effects of Purified n-3 Fatty Acids on Serum Fibrosis Markers and Cardiovascular Risk Markers in a Randomized Placebo Controlled Trial in Patients With Non Alcoholic Fatty Liver Disease

University Hospital Southampton NHS Foundation Trust·interventional·Posted Sep 26, 2008·Updated Oct 25, 2019

In Brief

A Phase 4 clinical trial evaluating OMACOR and Placebo oral capsule for Non-Alcoholic Fatty Liver Disease. Completed, enrolled 103 participants across 1 site.

Detailed Summary

Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS, yet there is presently no licensed treatment or validated approach to management. NAFLD predisposes to increased risk of type 2 diabetes, increased risk of cardiovascular disease and may progress to chronic irreversible liver disease. In NAFLD patients, the investigators will test the hypothesis that treatment with long chain n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and risk factors for cardiovascular disease and type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2008
Enrollment StartNov 1, 2009
Primary CompletionNov 1, 2013
Study CompletionNov 29, 2018
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.8 years ago

Interventions

OMACORdrug

4 grammes daily, oral capsule

Placebo oral capsuledrug

4 grammes daily, oral capsule (olive oil)