NCT00349375

Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,040 (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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Fenofibrate/Simvastatin	Combination of Fenofibrate 145mg and Simvastatin 20mg
DRUG	Fenofibrate/Simvastatin	Combination of Fenofibrate and Simvastatin 40 mg
DRUG	Simvastatin	Simvastatin 40 mg

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-07-07
• Last updated: 2009-07-08

Locations

110 sites across 8 countries: Czechia, Denmark, France, Germany, Hungary, Netherlands, Poland, Ukraine