Phase 2 N=220 Randomized Double-blind Treatment

Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT00504829 ↗

Enrolled (actual)

220

Serious AEs

1.4%

Results posted

Feb 2020

Primary outcome: 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 percent change from baseline

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LCP-AtorFen (Drug); atorvastatin (Drug); fenofibrate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Veloxis Pharmaceuticals
Primary completion: Feb 2008

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	—

Summary

The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

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.

View full record on ClinicalTrials.gov →

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.