Phase 3
Completed N=647
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
Source: ClinicalTrials.gov NCT01408303 ↗Enrolled (actual)
647
Serious AEs
1.1%
Results posted
Dec 2014
Primary outcomePrimary: Serum Non-HDL Cholesterol — -3.86; -6.91; -0.91 Percent change from baseline — p=<0.05
Summary
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Non-HDL Cholesterol |
-3.86; -6.91; -0.91 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Men or women, ≥18 years of age.
- Fasting triglyceride (TG) level ≥200 mg/dL and 4 weeks at Visit 1, or is unstable during screening.
- Use of >750 mL/d grapefruit juice during screening.
- Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
- History of pancreatitis.
- Type I diabetes mellitus, use of insulin, or HbA1c >10% at Visit 1.
- Poorly controlled hypertension
- Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >1.5xULN at Visit 2.
- Recent history or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
- History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.
- Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an acceptable method of contraception.
- Creatine kinase >5.0 times upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN at Visit 2.
- Current or recent history (past 12 months) of drug or alcohol abuse.
- Exposure to any investigational agent within 4 weeks prior to Visit 1.
- Any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
Data sourced from ClinicalTrials.gov (NCT01408303). 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. Informational only — not medical advice.