NCT01047683

Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL

Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 229 (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 fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	AMR101 (ethyl icosapentate) - 4 g/day	AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
DRUG	AMR101 (ethyl icosapentate) - 2 g/day	AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
DRUG	Placebo	Placebo 4 capsules/day for 12 weeks (Weeks 1-12)

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-10-01
• Completion: 2011-07-01
• First posted: 2010-01-13
• Last updated: 2022-04-25
• Results posted: 2022-04-25

Locations

60 sites across 11 countries: United States, Denmark, Finland, Germany, India, Italy, Mexico, Netherlands, Russia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study