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

Amarin

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: Placebo; Drug: AMR101 (ethyl icosapentate) - 2 g/day; Drug: AMR101 (ethyl icosapentate) - 4 g/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT01047501

The ANCHOR Study (Other Identifier)

AMR-01-01-0017

Details and patient eligibility

About

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.

Enrollment: 702 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

702 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

AMR101 (ethyl icosapentate) - 2 g/day

Experimental group

Treatment:

Drug: AMR101 (ethyl icosapentate) - 2 g/day

AMR101 (ethyl icosapentate) - 4 g/day

Experimental group

Treatment:

Drug: AMR101 (ethyl icosapentate) - 4 g/day