NCT00349284

A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome

A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 181 (planned)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

Conditions

• Hyperlipidemia Combined

Interventions

Type	Name	Description
DRUG	Combination of 145 mg fenofibrate and 10 mg ezetimibe

Timeline

• Start date: 2005-01-01
• First posted: 2006-07-06
• Last updated: 2007-09-03

Locations

43 sites across 3 countries: Belgium, France, Germany