Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Solvay

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Pravastatin; Drug: Fenofibrate/Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362206

2006-000515-15

C LF0242780-01 05 04

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

Enrollment: 423 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 pravastatin
• Pregnant or lactating women
• Contra-indication to fenofibrate or simvastatin or pravastatin
• Unstable or severe cardiac disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

423 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Fenofibrate/Simvastatin

Drug: Fenofibrate/Simvastatin

2

Experimental group

Treatment:

Drug: Fenofibrate/Simvastatin

Drug: Fenofibrate/Simvastatin

3

Active Comparator group

Treatment:

Drug: Pravastatin