drugset / Trial / NCT00362206

Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

NCT00362206

Phase 3 Completed 423 enrolled Solvay Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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 pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Timeline

Start
2006-09
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 145 mg
Comparator Pravastatin Small molecule 40 mg
Subject Simvastatin Small molecule 20 mg
Subject Simvastatin Small molecule 40 mg

Indications