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Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)

NCT01047501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2022-04-25

Study results available
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Summary

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

AMR101 (ethyl icosapentate) - 4 g/day

AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks

DRUG

AMR101 (ethyl icosapentate) - 2 g/day

AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks

DRUG

Placebo

Placebo 4 capsules/day for 12 weeks

Sponsors & Collaborators

  • Amarin Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-02-28
Completion
2011-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01047501 on ClinicalTrials.gov