Phase 3
N=702
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT01047501 ↗Enrolled (actual)
702
Serious AEs
2.6%
Results posted
Apr 2022
Primary outcome: Primary: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect — -5.6; -17.5; 5.9 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
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect |
-5.6; -17.5; 5.9 | <0.0001 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels |
2.4; 1.5; 8.8 | 0.0067 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels |
2.4; -5.0; 9.8 | 0.0001 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels |
1.6; -12.1; 15.0 | 0.0001 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels |
-1.8; -12.8; 6.7 | 0.0001 sig |
| SECONDARY Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels |
1.6; -2.2; 7.1 | 0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women, ages >18
- Fasting triglyceride ≥200 mg/dL and 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 (NCT01047501). 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.