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Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL

NCT01047683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229

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 fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

AMR101 (ethyl icosapentate) - 4 g/day

AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)

DRUG

AMR101 (ethyl icosapentate) - 2 g/day

AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)

DRUG

Placebo

Placebo 4 capsules/day for 12 weeks (Weeks 1-12)

Sponsors & Collaborators

  • Amarin Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-10-31
Completion
2011-07-31
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Finland
  • Germany
  • India
  • Italy
  • Mexico
  • Netherlands
  • Russia
  • South Africa
  • Ukraine

Study Locations

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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 NCT01047683 on ClinicalTrials.gov