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

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Fenofibrate/Simvastatin; Drug: Simvastatin

• Registration Number: NCT00349375
• Lead Sponsor: Solvay Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-07
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1040

Inclusion Criteria

• Mixed dyslipidemia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Fenofibrate/Simvastatin	-
3	Simvastatin	-
1	Fenofibrate/Simvastatin	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline to 24 weeks of treatment in Triglycerides	12 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C	12 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline to 24 weeks of treatment in Triglycerides	24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C	24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C	24 weeks

Trial Locations

Locations (110)

Site 008; 🇨🇿 Brno, Czech Republic

Site 009; 🇨🇿 Brno, Czech Republic

Site 010; 🇨🇿 Brno, Czech Republic

Site 015; 🇨🇿 Hradisk, Czech Republic

Site 019; 🇨🇿 Karlovy Vary, Czech Republic

Site 014; 🇨🇿 Kladno, Czech Republic

Site 005; 🇨🇿 Nymburk, Czech Republic

Site 012; 🇨🇿 Olomouc, Czech Republic

Site 013; 🇨🇿 Olomouc, Czech Republic

Site 007; 🇨🇿 Plzen, Czech Republic

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