Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Solvay

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: fenofibrate / simvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362934

2006-000519-21

C LF0242780-01 05 03

Details and patient eligibility

About

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.

Enrollment: 516 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mixed dyslipidemia.

Exclusion criteria

• Known hypersensitivity to fenofibrates or simvastatin or atorvastatin
• Pregnant or lactating women
• Contra-indication to fenofibrate or simvastatin or atorvastatin
• Unstable or severe cardiac disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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516 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: fenofibrate / simvastatin

2

Active Comparator group

Treatment:

Drug: Atorvastatin