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

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Placebo; Drug: AMR101 (ethyl icosapentate) - 2 g/day; Drug: AMR101 (ethyl icosapentate) - 4 g/day

• Registration Number: NCT01047501
• Lead Sponsor: Amarin Pharma Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Disposition First Submitted: 2013-10-10
• Disposition First Submitted QC: 2013-10-10
• Disposition First Posted: 2013-11-05
• Results First Submitted: 2022-02-09
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Results First Posted: 2022-04-25
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 702

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AMR101 (ethyl icosapentate) - 2 g/day	AMR101 (ethyl icosapentate) - 2 g/day	-
AMR101 (ethyl icosapentate) - 4 g/day	AMR101 (ethyl icosapentate) - 4 g/day	-

Primary Outcome Measures

Name	Time	Method
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect	baseline and 12 weeks	Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Secondary Outcome Measures

Name	Time	Method
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels	baseline and 12 weeks	Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels	baseline and 12 weeks	Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels	baseline and 12 weeks	Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels	baseline and 12 weeks	Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels	baseline and 12 weeks	Median percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Trial Locations

Locations (1)

Amarin Investigational Site; 🇺🇸 Wauwatosa, Wisconsin, United States