Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin Alone

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Drug: Fenofibrate/Simvastatin
* Drug: Fenofibrate/Simvastatin
* Drug: Pravastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Fenofibrate/Simvastatin<br>* Combination of Fenofibrate and Simvastatin 20mg<br>|
| Experimental: 2<br> | Drug: Fenofibrate/Simvastatin<br>* Combination of Fenofibrate and Simvastatin 40 mg<br>|
| Active Comparator: 3<br> | Drug: Pravastatin<br>* Pravastatin 40 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 12 weeks of treatment in Triglycerides |  | 12 weeks | 
| Percent change from baseline to 12 weeks of treatment in HDL-C |  | 12 weeks | 
| Percent change from baseline to 12 weeks of treatment in LDL-C |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 12 weeks of treatment in Triglycerides |  | 24 weeks | 
| Percent change from baseline to 12 weeks of treatment in HDL-C |  | 24 weeks | 
| Percent change from baseline to 12 weeks of treatment in LDL-C |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin, Hyperlipidemia Combined