Conditions: Dyslipidemia
Keywords: LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol LDL cholesterol Atorvastatin Fenofibrate
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 140
Healthy volunteers: no

Brief summary:
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

Detailed description:
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).

Arms:
arm 1: Open-label LCP-AtorFen

Interventions: intervention 1: LCP-AtorFen
Intervention descriptions: intervention 1: All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.

Protocol document: