Dyslipidemia Clinical Trial
Official title:
A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
POPULATION:
Subjects with mixed dyslipidemia (non-HDL cholesterol > 130 mg/dL and TG ≥ 150 mg/dL and ≤
500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the
enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and
elected to enter the open-label extension study.
STUDY DESIGN AND DURATION:
This is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36,
48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and
efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled
in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the
extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).
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