drugset / Trial / NCT00349375

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

NCT00349375

Phase 3 Completed 1040 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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Timeline

Start
2005-11
Primary completion
2008-09
Completion
2008-09

Drugs

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

Indications