NCT01047501

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: Amarin Pharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	AMR101 (ethyl icosapentate) - 4 g/day	AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
DRUG	AMR101 (ethyl icosapentate) - 2 g/day	AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
DRUG	Placebo	Placebo 4 capsules/day for 12 weeks

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-01-13
• Last updated: 2022-04-25
• Results posted: 2022-04-25

Locations

80 sites across 1 country: United States

Regulatory

• FDA-regulated drug study