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Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

NCT01154985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2014-11-20

Study results available
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Summary

This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).

Conditions

  • Steatohepatitis

Interventions

DRUG

Placebo capsule

3x Placebo capsules three times a day (TID) for 365 days

DRUG

EPA-E 300 mg capsule

2x 300 mg capsules + placebo capsule TID for 365 days

DRUG

EPA-E 300 mg capsule

3x 300 mg capsules TID for 365 days

Sponsors & Collaborators

  • Mochida Pharmaceutical Company, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01154985 on ClinicalTrials.gov