NCT00362934

Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	fenofibrate / simvastatin	Combination of fenofibrate and simvastatin 20 mg and 40 mg
DRUG	Atorvastatin	Atorvastatin 10 mg and 20mg

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-08-15
• Last updated: 2009-07-08

Locations

68 sites across 5 countries: Bulgaria, Czechia, Germany, Slovakia, Ukraine