NCT00664859

12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia

A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Veloxis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	LCP-AtorFen	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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-04-23
• Last updated: 2020-03-24
• Results posted: 2020-03-24

Locations

1 site across 1 country: United States