Phase 3
N=229
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT01047683 ↗Enrolled (actual)
229
Serious AEs
0.9%
Results posted
Apr 2022
Primary outcome: Primary: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect — -7.0; -26.6; 9.7 Percent change from baseline — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AMR101 (ethyl icosapentate) - 4 g/day (Drug); AMR101 (ethyl icosapentate) - 2 g/day (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amarin Pharma Inc.
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect |
-7.0; -26.6; 9.7 | <0.0001 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels |
0.0; -19.5; 13.7 | 0.0005 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels |
-5.1; -17.1; -2.4 | 0.0006 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels |
2.1; -3.8; 4.3 | 0.0019 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women, ages >18
- Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL
- 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 pancreatitis
- 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.
Data sourced from ClinicalTrials.gov (NCT01047683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.