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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy

NCT01047501•Amarin Pharma Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women, ages \>18
•Fasting triglyceride ≥200 mg/dL and \<500 mg/dL
•LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and \<100 mg/dL
•High risk for coronary heart disease
•On stable dose of statin (atorvastatin, rosuvastatin or simvastatin)
•Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria

•Women who are pregnant or lactating, or planning to become pregnant
•Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects
•History of bariatric surgery or currently on weight loss drugs
•Uncontrolled hypertension (BP \> 160/100)
•HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin
•Consumption of more than 2 alcoholic beverages per day
•History of cancers (except if been disease free for \>5 years OR history was basal or squamous cell skin cancer)
•Participation in another clinical trial involving an investigational agent in the last 30 days
•Other parameters will be assessed at the study center to ensure eligibility for this study.

Locations (80)

Amarin Investigational Site

Muscle Shoals, Alabama, United States

Amarin Investigational Site

Scottsboro, Alabama, United States

Amarin Investigational Site

Phoenix, Arizona, United States

Amarin Investigational Site

Tucson, Arizona, United States

Amarin Investigational Site

Anaheim, California, United States

Amarin Investigational Site

Burbank, California, United States

Amarin Investigational Site

Chino, California, United States

Amarin Investigational Site

Encinitas, California, United States

Amarin Investigational Site

Irvine, California, United States

Amarin Investigational Site

Los Angeles, California, United States

Key Dates

Start Date

December 1, 2009

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2011

Last Updated

April 25, 2022

Enrollment

702

ACTUAL participants

Conditions

Hypertriglyceridemia

Interventions

AMR101 (ethyl icosapentate) - 4 g/day

DRUG

AMR101 (ethyl icosapentate) - 2 g/day

DRUG

Placebo

DRUG

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Hypertriglyceridemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

A Study of SHR-1918 In Participants With Hypertriglyceridemia

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers

Chia Seeds Consumption in Hypertriglyceridemia

Impacts of Aronia on Inflammation and the Gut Microbiome