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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT01047501

Run by

Amarin Pharma Inc.

People needed

702

Starts

2009-12-01

Expected to finish

2011-02-01

Last updated by the study team

2022-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Amarin Investigational Site — Los Angeles, California, United States
• Amarin Investigational Site — Spring Valley, California, United States
• Amarin Investigational Site — Westlake Village, California, United States
• Amarin Investigational Site — Golden, Colorado, United States
• Amarin Investigational Site — Wheat Ridge, Colorado, United States
• Amarin Investigational Site — Aventura, Florida, United States
• Amarin Investigational Site — Clearwater, Florida, United States
• Amarin Investigational Site — Coral Gables, Florida, United States
• Amarin Investigational Site — Hialeah, Florida, United States
• Amarin Investigational Site — Jacksonville, Florida, United States
• Amarin Investigational Site — Jacksonville, Florida, United States
• Amarin Investigational Site — Miami, Florida, United States
• Amarin Investigational Site — New Port Richey, Florida, United States
• Amarin Investigational Site — New Port Richey, Florida, United States
• Amarin Investigational Site — Orlando, Florida, United States
• Amarin Investigational Site — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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