Phase 2
Completed N=220
Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
Source: ClinicalTrials.gov NCT00504829 ↗Enrolled (actual)
220
Serious AEs
1.4%
Results posted
Feb 2020
Primary outcomePrimary: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy — -44.8; -40.2; -49.1; -28.9 percent change from baseline
Summary
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy |
-44.8; -40.2; -49.1; -28.9; 19.7; 6.5 | — |
| SECONDARY Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy |
-44.8; -16.1; -42.3; -13.9; 19.7; 18.2 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150 mg/dL and 1000 mg of fish oil per day.
- Other inclusion criteria might apply
Exclusion Criteria
- TGs > 500 mg/dL.
- History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
- Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
- Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy.
- Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
- History of pancreatitis.
- Known allergy or sensitivity to statins or fibrates.
- Poorly controlled hypertension.
- Other exclusion criteria might apply.
Data sourced from ClinicalTrials.gov (NCT00504829). 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.