Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: fenofibrate / simvastatin; Drug: Atorvastatin

• Registration Number: NCT00362934
• 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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Study Start: 2006-10
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fenofibrate / simvastatin	-
2	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (68)

Site 501; 🇧🇬 Haskovo, Bulgaria

Site 505; 🇧🇬 Pleven, Bulgaria

Site 503; 🇧🇬 Plovdiv, Bulgaria

Site 506; 🇧🇬 Plovdiv, Bulgaria

Site 500; 🇧🇬 Sofia, Bulgaria

Site 502; 🇧🇬 Sofia, Bulgaria

Site 504; 🇧🇬 Sofia, Bulgaria

Site 507; 🇧🇬 Sofia, Bulgaria

Site 509; 🇧🇬 Sofia, Bulgaria

Site 511; 🇧🇬 Sofia, Bulgaria

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