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

Solvay

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Drug: Fenofibrate/Simvastatin; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00352183

ACTRN012605000777695

C LF0242780-01 05 02

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

Enrollment: 450 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mixed dyslipidemia

Exclusion criteria

• Diabetes,
• Known hypersensitivity to fenofibrate or simvastatin,
• Pregnant or lactating women,
• Contra-indication to fenofibrate or simvastatin,
• Unstable or severe cardiac disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Fenofibrate/Simvastatin

2

Active Comparator group

Treatment:

Drug: Simvastatin