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

Official Title: “A Multicenter, Double-Blind, Randomized, Active Comparator, 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 Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone”

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.

Intervention(s) in this Clinical Trial

• Drug: Fenofibrate/Simvastatin
  • Combination of Fenofibrate 145mg and Simvastatin 20mg
• Drug: Fenofibrate/Simvastatin
  • Combination of Fenofibrate and Simvastatin 40 mg
• Drug: Simvastatin
  • Simvastatin 40 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3

Primary Measures

• Percent change from baseline to 24 weeks of treatment in Triglycerides
  • Time Frame: 12 weeks
    Safety Issue?: No
• Percent change from baseline to 24 weeks of treatment in HDL-C
  • Time Frame: 12 weeks
    Safety Issue?: No
• Percent change from baseline to 24 weeks of treatment in LDL-C
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Percent change from baseline to 24 weeks of treatment in Triglycerides
  • Time Frame: 24 weeks
    Safety Issue?: No
• Percent change from baseline to 24 weeks of treatment in HDL-C
  • Time Frame: 24 weeks
    Safety Issue?: No
• Percent change from baseline to 24 weeks of treatment in LDL-C
  • Time Frame: 24 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Solvay Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00349375

Study ID Number: C LF0242780-01 05 01

ClinicalTrials.gov Identifier: NCT00349375

Health Authority: France: Afssaps - French Health Products Safety Agency