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A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

NCT01492361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8179

Last updated 2022-04-14

Study results available
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Summary

AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.

Conditions

Interventions

DRUG

AMR101

Parallel Assignment

DRUG

Placebo

Parallel Assignment

DRUG

Statin therapy

Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)

Sponsors & Collaborators

  • Amarin Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Deepak L. Bhatt, MD, MPH · Brigham and Women's Hospital, 75 Francis Street, Boston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States
  • Australia
  • Canada
  • India
  • Netherlands
  • New Zealand
  • Poland
  • Romania
  • Russia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01492361 on ClinicalTrials.gov