Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amarin Pharma Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)